https://qibawiki.rsna.org/api.php?action=feedcontributions&user=Jlisiecki&feedformat=atomQIBA Wiki - User contributions [en]2024-03-29T13:30:47ZUser contributionsMediaWiki 1.35.5https://qibawiki.rsna.org/index.php?title=Profile_Editions&diff=19647Profile Editions2024-01-19T20:01:50Z<p>Jlisiecki: </p>
<hr />
<div>Because multiple editions of a given Profile are formally published as it advances through the QIBA Process, ensure certain details are visible when referencing the Profile by using the following template:<br />
* <'''Modality'''> <'''Biomarker Name'''> - <'''Publication Date'''> ('''Stage''')<br />
<br />
'''Modality''' and '''Stage''' should be obvious. '''Publication Date''' is the date of the draft at the end of the [[Review Process|'''publication approval process''']].<br />
<br />
The '''Biomarker Name''' is determined by the Profile Authoring Group based on what is both clear and convenient to their community. Often it will make sense to include the relevant anatomy if that is key to the biomarker scope. The use of abbreviations and acronyms is up to the Profile Authoring Group based on what would be clear to their intended clinical audience. Try to keep the Biomarker Name short enough that people can conveniently refer to it verbally.<br />
<br />
For examples, refer to the '''[[Profiles]]''' page.<br />
<br />
''Rationale'':<br />
<br />
The modality is a useful way to group biomarkers and is often a key piece of scope.<br />
<br />
It is important to understand that a Profile embodies trade-off choices between what requirements were considered reasonably achievable and what performance was considered useful/acceptable. Those choices, however, represent a snapshot at a particular point in time. Over time, performance expectations may increase (for example to meet the needs of a new clinical application) and new technologies may become more widely available in the installed base, making it practical to raise conformance requirements.<br />
<br />
The publication date indicates which of two editions of a Profile is newer and also provides a temporal context for the tradeoffs. A 2018 Profile reflects the expectations and technologies of 2018. <br />
<br />
It is expected that new editions of a Profile may be published when there are significant advancements in technology and/or expectations. Older sites and systems can still claim conformance to the older editions of a Profile, while others will pursue more cutting-edge performance. <br />
<br />
The [[QIBA Profile Stages|'''Profile Stage''']] is important to understand the level of maturity and stability of the Profile. A Clinically Feasible or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance. <br />
<br />
''Usage'': <br />
<br />
A product conformance claim might say <br />
* This product conforms to the QIBA PET Amyloid 2022-06-03 (Clinically Feasible) Profile as the Acquisition Device actor.<br />
A site conformance claim might say<br />
* This site conforms to the QIBA CT Lung Density 2020-09-04 (Consensus) Profile.<br />
Documents such as Clinical Trial Protocols, imaging guidelines, or publications from professional organizations or commercial entities might say things like<br />
<br />
* This protocol incorporates the requirements of the QIBA MR Elastography of the Liver 2022-02-14 (Clinically Feasible) Profile.</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Profile_Editions&diff=19646Profile Editions2024-01-19T20:01:29Z<p>Jlisiecki: </p>
<hr />
<div>Because multiple editions of a given Profile are formally published as it advances through the QIBA Process, ensure certain details are visible when referencing the Profile by using the following template:<br />
* <'''Modality'''> <'''Biomarker Name'''> - <'''Publication Date'''> ('''Stage''')<br />
<br />
'''Modality''' and '''Stage''' should be obvious. '''Publication Date''' is the date of the draft at the end of the [[Review Process|'''publication approval process''']].<br />
<br />
The '''Biomarker Name''' is determined by the Profile Authoring Group based on what is both clear and convenient to their community. Often it will make sense to include the relevant anatomy if that is key to the biomarker scope. The use of abbreviations and acronyms is up to the Profile Authoring Group based on what would be clear to their intended clinical audience. Try to keep the Biomarker Name short enough that people can conveniently refer to it verbally.<br />
<br />
For examples, refer to the '''[[Profiles]]''' page.<br />
<br />
''Rationale'':<br />
<br />
The modality is a useful way to group biomarkers and is often a key piece of scope.<br />
<br />
It is important to understand that a Profile embodies trade-off choices between what requirements were considered reasonably achievable and what performance was considered useful/acceptable. Those choices, however, represent a snapshot at a particular point in time. Over time, performance expectations may increase (for example to meet the needs of a new clinical application) and new technologies may become more widely available in the installed base, making it practical to raise conformance requirements.<br />
<br />
The publication date indicates which of two editions of a Profile is newer and also provides a temporal context for the tradeoffs. A 2018 profile reflects the expectations and technologies of 2018. <br />
<br />
It is expected that new editions of a Profile may be published when there are significant advancements in technology and/or expectations. Older sites and systems can still claim conformance to the older editions of a Profile, while others will pursue more cutting-edge performance. <br />
<br />
The [[QIBA Profile Stages|'''Profile Stage''']] is important to understand the level of maturity and stability of the Profile. A Clinically Feasible or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance. <br />
<br />
''Usage'': <br />
<br />
A product conformance claim might say <br />
* This product conforms to the QIBA PET Amyloid 2022-06-03 (Clinically Feasible) Profile as the Acquisition Device actor.<br />
A site conformance claim might say<br />
* This site conforms to the QIBA CT Lung Density 2020-09-04 (Consensus) Profile.<br />
Documents such as Clinical Trial Protocols, imaging guidelines, or publications from professional organizations or commercial entities might say things like<br />
<br />
* This protocol incorporates the requirements of the QIBA MR Elastography of the Liver 2022-02-14 (Clinically Feasible) Profile.</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Profile_Editions&diff=19645Profile Editions2024-01-19T20:00:45Z<p>Jlisiecki: </p>
<hr />
<div>Because multiple editions of a given Profile are formally published as it advances through the QIBA Process, ensure certain details are visible when referencing the Profile by using the following template:<br />
* <'''Modality'''> <'''Biomarker Name'''> - <'''Publication Date'''> ('''Stage''')<br />
<br />
'''Modality''' and '''Stage''' should be obvious. '''Publication Date''' is the date of the draft at the end of the [[Review Process|'''publication approval process''']].<br />
<br />
The '''Biomarker Name''' is determined by the Profile Authoring Group based on what is both clear and convenient to their community. Often it will make sense to include the relevant anatomy if that is key to the biomarker scope. The use of abbreviations and acronyms is up to the Profile Authoring Group based on what would be clear to their intended clinical audience. Try to keep the Biomarker Name short enough that people can conveniently refer to it verbally.<br />
<br />
For examples, refer to the '''[[Profiles]]''' page.<br />
<br />
''Rationale'':<br />
<br />
The modality is a useful way to group biomarkers and is often a key piece of scope.<br />
<br />
It is important to understand that a Profile embodies trade-off choices between what requirements were considered reasonably achievable and what performance was considered useful/acceptable. Those choices, however, represent a snapshot at a particular point in time. Over time, performance expectations may increase (for example to meet the needs of a new clinical application) and new technologies may become more widely available in the installed base, making it practical to raise conformance requirements.<br />
<br />
The publication date indicates which of two editions of a profile is newer and also provides a temporal context for the tradeoffs. A 2018 profile reflects the expectations and technologies of 2018. <br />
<br />
It is expected that new editions of a Profile may be published when there are significant advancements in technology and/or expectations. Older sites and systems can still claim conformance to the older editions of a Profile, while others will pursue more cutting-edge performance. <br />
<br />
The [[QIBA Profile Stages|'''Profile Stage''']] is important to understand the level of maturity and stability of the Profile. A Clinically Feasible or Claim Confirmed Profile is a stable specification to which products and sites can claim conformance. <br />
<br />
''Usage'': <br />
<br />
A product conformance claim might say <br />
* This product conforms to the QIBA PET Amyloid 2022-06-03 (Clinically Feasible) Profile as the Acquisition Device actor.<br />
A site conformance claim might say<br />
* This site conforms to the QIBA CT Lung Density 2020-09-04 (Consensus) Profile.<br />
Documents such as Clinical Trial Protocols, imaging guidelines, or publications from professional organizations or commercial entities might say things like<br />
<br />
* This protocol incorporates the requirements of the QIBA MR Elastography of the Liver 2022-02-14 (Clinically Feasible) Profile.</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Claim_Confirmation_Process&diff=19644Claim Confirmation Process2024-01-19T19:57:18Z<p>Jlisiecki: /* Solicited Feedback after Publication */</p>
<hr />
<div>{{TOCright}}<br />
==Planning==<br />
<TBA> See [[Process Coordinating Committee]]<br />
<br />
The key purpose in Claim Confirmation is to:<br />
* to evaluate the validity of the statistical assumptions underlying the Profiles Claims<br />
* to confirm that the actual performance at a real site is consistent with the performance in the Profile Claims<br />
<br />
While it is acceptable to conduct separate studies at two or more sites, it is recommended that a multi-site study be conducted where the data from the sites are pooled and the mean performance is reported. For example, to assess the magnitude of the wCV, a similar number of test-retest cases from two or more sites is collected; the mean wCV from the cases of all sites is estimated, with a 95% CI, and compared with the precision assumption underlying the claims. Note that the sample size for the study should be sufficient such that the 95% CI will provide a tight estimate that rules out values not supportive of the claim.<br />
<br />
==Soliciting Feedback==<br />
<br />
''<This is just copied from Technical Confirmation. Probably need to re-write>''<br />
<br />
This step collects feedback on use of the document by implementers and users in the field, including clinical oncologists, imaging scientists, pharma, CROs, etc. <br />
<br />
Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used it and only those that have used it.<br />
<br />
A procedure is outlined below listing what is done ('''by whom''').<br />
<br />
<br />
Period: 30 days<br />
<br />
* Collect list of people that have participated in the field test ('''Field Test Leader''')<br />
* Finalize comment form that will be used in the survey ('''Profile Authoring Group''')<br />
** ''<Q. What's the relationship between this comment form and the standard form linked below?>''<br />
* Announce Call for Feedback to mailing lists ('''Profile Authoring Group'''), including<br />
** link to the document <br />
** link to the [[:Media:QIBA_User_Feedback_Template-2011.01.doc | QIBA Trial Implementation Feedback Template]]<br />
* Email completed Feedback Template to Field Test leader ('''Commenters''')<br />
* Collate all Feedback comments into a spreadsheet ('''Profile Authoring Group/Field Test Leader''')<br />
* Additionally, summarize feedback into a report ('''Field Test Leader''').<br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either:<br />
** refer the document for Final Text publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
* Post comment spreadsheet, revised document to the Wiki ('''Field Test Leader/Profile Authoring Group)<br />
<br />
==Solicited Feedback after Publication==<br />
The purpose of this process step is to actively seek and periodically respond to feedback on use of published documents. It is important to put this into context with other activities that may seem similar at first: Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time clinical trials may complete that had been designed with this, and/or other results from field usage may become evident either with the user or supplier base. As such, comments are solicited periodically for a wide range of the public that may connect with it in some way.<br />
<br />
A procedure is outlined below listing what is done (by whom).<br />
<br />
<br />
Period: 30 days<br />
<br />
* Periodically, collect list of people that may have used the document and/or professional societies that may have a particular relationship to the document (Profile Authoring Group)<br />
* Finalize comment form that will be used in the survey (Profile Authoring Group)<br />
* Send announcement to mailing lists (Profile Authoring Group)<br />
** reminder copy of document that has been placed into field test<br />
** provide a link to the [[:Media:QIBA_Maintenance_Phase_Feedback_Template-2011.01.doc | QIBA User Feedback Template]]<br />
* Email comments to Profile Authoring Group (Commenters)<br />
** Commenters include full range of users of the document, e.g., vendors/suppliers, clinical oncologists, imaging scientists, pharma, CROs, etc. However, only people who have used document are included.<br />
** Please use the provided comment form<br />
* Collate all comments into a spreadsheet (Profile Authoring Group)<br />
** Summarize range of feedback to the questions into a report for review by the Profile Authoring Group.<br />
** Profile Authoring Group decides what changes to make (if any) to the document and whether to refer it for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document.<br />
* Record resolution in spreadsheet<br />
** Regardless of recommended status for this document, ensure that the results are made available to related activities</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Claim_Confirmation_Process&diff=19643Claim Confirmation Process2024-01-19T19:54:27Z<p>Jlisiecki: /* Soliciting Feedback */</p>
<hr />
<div>{{TOCright}}<br />
==Planning==<br />
<TBA> See [[Process Coordinating Committee]]<br />
<br />
The key purpose in Claim Confirmation is to:<br />
* to evaluate the validity of the statistical assumptions underlying the Profiles Claims<br />
* to confirm that the actual performance at a real site is consistent with the performance in the Profile Claims<br />
<br />
While it is acceptable to conduct separate studies at two or more sites, it is recommended that a multi-site study be conducted where the data from the sites are pooled and the mean performance is reported. For example, to assess the magnitude of the wCV, a similar number of test-retest cases from two or more sites is collected; the mean wCV from the cases of all sites is estimated, with a 95% CI, and compared with the precision assumption underlying the claims. Note that the sample size for the study should be sufficient such that the 95% CI will provide a tight estimate that rules out values not supportive of the claim.<br />
<br />
==Soliciting Feedback==<br />
<br />
''<This is just copied from Technical Confirmation. Probably need to re-write>''<br />
<br />
This step collects feedback on use of the document by implementers and users in the field, including clinical oncologists, imaging scientists, pharma, CROs, etc. <br />
<br />
Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used it and only those that have used it.<br />
<br />
A procedure is outlined below listing what is done ('''by whom''').<br />
<br />
<br />
Period: 30 days<br />
<br />
* Collect list of people that have participated in the field test ('''Field Test Leader''')<br />
* Finalize comment form that will be used in the survey ('''Profile Authoring Group''')<br />
** ''<Q. What's the relationship between this comment form and the standard form linked below?>''<br />
* Announce Call for Feedback to mailing lists ('''Profile Authoring Group'''), including<br />
** link to the document <br />
** link to the [[:Media:QIBA_User_Feedback_Template-2011.01.doc | QIBA Trial Implementation Feedback Template]]<br />
* Email completed Feedback Template to Field Test leader ('''Commenters''')<br />
* Collate all Feedback comments into a spreadsheet ('''Profile Authoring Group/Field Test Leader''')<br />
* Additionally, summarize feedback into a report ('''Field Test Leader''').<br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either:<br />
** refer the document for Final Text publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
* Post comment spreadsheet, revised document to the Wiki ('''Field Test Leader/Profile Authoring Group)<br />
<br />
==Solicited Feedback after Publication==<br />
The purpose of this process step is to actively seek and periodically respond to feedback on use of published documents. It is important to put this into context with other activities that may seem similar at first: Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time clinical trials may complete that had been designed with this, and/or other results from field usage may become evident either with the user or supplier base. As such, comments are solicited periodically for a wide range of the public that may connect with it in some way.<br />
<br />
A procedure is outlined below listing what is done (by whom).<br />
<br />
<br />
Period: 30 days<br />
<br />
* Periodically, collect list of people that may have used the document and/or professional societies that may have a particular relationship to the document (RSNA Staff)<br />
* Finalize comment form that will be used in the survey (RSNA Staff with technical committee)<br />
* Send announcement to mailing lists (RSNA Staff)<br />
** reminder copy of document that has been placed into field test<br />
** provide a link to the [[:Media:QIBA_Maintenance_Phase_Feedback_Template-2011.01.doc | QIBA User Feedback Template]]<br />
* Email comments to RSNA Staff (Commenters)<br />
** commenters include full range of users of the document, e.g., vendors/suppliers, clinical oncologists, imaging scientists, pharma, CRO’s, etc. However, only people who have used document are included.<br />
** please use the provided comment form<br />
* Collate all comments into a spreadsheet (RSNA Staff)<br />
** Summarize range of feedback to the questions into a report for review by the technical committee provided by RSNA Staff.<br />
** Technical Committee decides what changes to make (if any) to the document and whether to refer it to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document<br />
* Record resolution in spreadsheet<br />
** Regardless of recommended status for this document, ensure that the results are made available to related activities</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Claim_Confirmation_Process&diff=19642Claim Confirmation Process2024-01-19T19:53:21Z<p>Jlisiecki: /* Soliciting Feedback */</p>
<hr />
<div>{{TOCright}}<br />
==Planning==<br />
<TBA> See [[Process Coordinating Committee]]<br />
<br />
The key purpose in Claim Confirmation is to:<br />
* to evaluate the validity of the statistical assumptions underlying the Profiles Claims<br />
* to confirm that the actual performance at a real site is consistent with the performance in the Profile Claims<br />
<br />
While it is acceptable to conduct separate studies at two or more sites, it is recommended that a multi-site study be conducted where the data from the sites are pooled and the mean performance is reported. For example, to assess the magnitude of the wCV, a similar number of test-retest cases from two or more sites is collected; the mean wCV from the cases of all sites is estimated, with a 95% CI, and compared with the precision assumption underlying the claims. Note that the sample size for the study should be sufficient such that the 95% CI will provide a tight estimate that rules out values not supportive of the claim.<br />
<br />
==Soliciting Feedback==<br />
<br />
''<This is just copied from Technical Confirmation. Probably need to re-write>''<br />
<br />
This step collects feedback on use of the document by implementers and users in the field, including clinical oncologists, imaging scientists, pharma, CROs, etc. <br />
<br />
Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used it and only those that have used it.<br />
<br />
A procedure is outlined below listing what is done ('''by whom''').<br />
<br />
<br />
Period: 30 days<br />
<br />
* Collect list of people that have participated in the field test ('''Field Test Leader''')<br />
* Finalize comment form that will be used in the survey ('''Profile Authoring Group''')<br />
** ''<Q. What's the relationship between this comment form and the standard form linked below?>''<br />
* Announce Call for Feedback to mailing lists ('''Profile Authoring Group'''), including<br />
** link to the document <br />
** link to the [[:Media:QIBA_User_Feedback_Template-2011.01.doc | QIBA Trial Implementation Feedback Template]]<br />
* Email completed Feedback Template to Field Test leader ('''Commenters''')<br />
* Collate all Feedback comments into a spreadsheet ('''Profile Authoring Group/Field Test Leader''')<br />
* Additionally, summarize feedback into a report ('''Field Test Leader''').<br />
* Review comments, making changes to the document as needed ('''Technical Committee''')<br />
* Record comment resolutions in spreadsheet<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either:<br />
** refer the document for Final Text publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
* Post comment spreadsheet, revised document to the Wiki ('''Field Test Leader/Profile Authoring Group)<br />
<br />
==Solicited Feedback after Publication==<br />
The purpose of this process step is to actively seek and periodically respond to feedback on use of published documents. It is important to put this into context with other activities that may seem similar at first: Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time clinical trials may complete that had been designed with this, and/or other results from field usage may become evident either with the user or supplier base. As such, comments are solicited periodically for a wide range of the public that may connect with it in some way.<br />
<br />
A procedure is outlined below listing what is done (by whom).<br />
<br />
<br />
Period: 30 days<br />
<br />
* Periodically, collect list of people that may have used the document and/or professional societies that may have a particular relationship to the document (RSNA Staff)<br />
* Finalize comment form that will be used in the survey (RSNA Staff with technical committee)<br />
* Send announcement to mailing lists (RSNA Staff)<br />
** reminder copy of document that has been placed into field test<br />
** provide a link to the [[:Media:QIBA_Maintenance_Phase_Feedback_Template-2011.01.doc | QIBA User Feedback Template]]<br />
* Email comments to RSNA Staff (Commenters)<br />
** commenters include full range of users of the document, e.g., vendors/suppliers, clinical oncologists, imaging scientists, pharma, CRO’s, etc. However, only people who have used document are included.<br />
** please use the provided comment form<br />
* Collate all comments into a spreadsheet (RSNA Staff)<br />
** Summarize range of feedback to the questions into a report for review by the technical committee provided by RSNA Staff.<br />
** Technical Committee decides what changes to make (if any) to the document and whether to refer it to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document<br />
* Record resolution in spreadsheet<br />
** Regardless of recommended status for this document, ensure that the results are made available to related activities</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Claim_Confirmation_Process&diff=19641Claim Confirmation Process2024-01-19T19:52:41Z<p>Jlisiecki: /* Soliciting Feedback */</p>
<hr />
<div>{{TOCright}}<br />
==Planning==<br />
<TBA> See [[Process Coordinating Committee]]<br />
<br />
The key purpose in Claim Confirmation is to:<br />
* to evaluate the validity of the statistical assumptions underlying the Profiles Claims<br />
* to confirm that the actual performance at a real site is consistent with the performance in the Profile Claims<br />
<br />
While it is acceptable to conduct separate studies at two or more sites, it is recommended that a multi-site study be conducted where the data from the sites are pooled and the mean performance is reported. For example, to assess the magnitude of the wCV, a similar number of test-retest cases from two or more sites is collected; the mean wCV from the cases of all sites is estimated, with a 95% CI, and compared with the precision assumption underlying the claims. Note that the sample size for the study should be sufficient such that the 95% CI will provide a tight estimate that rules out values not supportive of the claim.<br />
<br />
==Soliciting Feedback==<br />
<br />
''<This is just copied from Technical Confirmation. Probably need to re-write>''<br />
<br />
This step collects feedback on use of the document by implementers and users in the field, including clinical oncologists, imaging scientists, pharma, CRO’s, etc. <br />
<br />
Whereas the review and public comment steps prior to this focused on the document itself, this step now seeks feedback on how well it works in practice. As such, comments are solicited specifically from those that have used it and only those that have used it.<br />
<br />
A procedure is outlined below listing what is done ('''by whom''').<br />
<br />
<br />
Period: 30 days<br />
<br />
* Collect list of people that have participated in the field test ('''Field Test Leader''')<br />
* Finalize comment form that will be used in the survey ('''Profile Authoring Group''')<br />
** ''<Q. What's the relationship between this comment form and the standard form linked below?>''<br />
* Announce Call for Feedback to mailing lists ('''Profile Authoring Group'''), including<br />
** link to the document <br />
** link to the [[:Media:QIBA_User_Feedback_Template-2011.01.doc | QIBA Trial Implementation Feedback Template]]<br />
* Email completed Feedback Template to Field Test leader ('''Commenters''')<br />
* Collate all Feedback comments into a spreadsheet ('''Profile Authoring Group/Field Test Leader''')<br />
* Additionally, summarize feedback into a report ('''Field Test Leader''').<br />
* Review comments, making changes to the document as needed ('''Technical Committee''')<br />
* Record comment resolutions in spreadsheet<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either:<br />
** refer the document for Final Text publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
* Post comment spreadsheet, revised document to the Wiki ('''Field Test Leader/Profile Authoring Group)<br />
<br />
==Solicited Feedback after Publication==<br />
The purpose of this process step is to actively seek and periodically respond to feedback on use of published documents. It is important to put this into context with other activities that may seem similar at first: Whereas the review and public comment steps that are part of the Drafting phase focus on the document itself, prior to its use, and the Collect Feedback step as part of the Field Test phase collects feedback on the initial use of the document given that it has been placed into trial implementation, this step is where longer-term, extended use of the document allows for actual assessment of its performance in practice. That is, over the course of time clinical trials may complete that had been designed with this, and/or other results from field usage may become evident either with the user or supplier base. As such, comments are solicited periodically for a wide range of the public that may connect with it in some way.<br />
<br />
A procedure is outlined below listing what is done (by whom).<br />
<br />
<br />
Period: 30 days<br />
<br />
* Periodically, collect list of people that may have used the document and/or professional societies that may have a particular relationship to the document (RSNA Staff)<br />
* Finalize comment form that will be used in the survey (RSNA Staff with technical committee)<br />
* Send announcement to mailing lists (RSNA Staff)<br />
** reminder copy of document that has been placed into field test<br />
** provide a link to the [[:Media:QIBA_Maintenance_Phase_Feedback_Template-2011.01.doc | QIBA User Feedback Template]]<br />
* Email comments to RSNA Staff (Commenters)<br />
** commenters include full range of users of the document, e.g., vendors/suppliers, clinical oncologists, imaging scientists, pharma, CRO’s, etc. However, only people who have used document are included.<br />
** please use the provided comment form<br />
* Collate all comments into a spreadsheet (RSNA Staff)<br />
** Summarize range of feedback to the questions into a report for review by the technical committee provided by RSNA Staff.<br />
** Technical Committee decides what changes to make (if any) to the document and whether to refer it to the Modality Committee for re-publication of an updated version, whether to branch the document leaving the current version in place but spawning a derivative, or to retire the document<br />
* Record resolution in spreadsheet<br />
** Regardless of recommended status for this document, ensure that the results are made available to related activities</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Vetting_Requirements&diff=19640Vetting Requirements2024-01-19T19:36:24Z<p>Jlisiecki: /* Violation Criteria */</p>
<hr />
<div>{{TOCright}}<br />
<br />
Profile Requirements '''tell Vendors and Site Staff what they must do''' to claim conformance with the Profile.<br />
<br />
<br />
The point of conformance to a Profile is '''to achieve the technical performance stated in the Claim'''.<br />
<br />
So, ''each'' requirement in a Profile should meet '''three criteria''':<br />
:* It discernably '''impacts the performance''' of the biomarker ([[Vetting Requirements#Impact Criteria|Impact Criteria]])<br />
:* It is '''violated''' often enough '''in practice''' to be worth addressing ([[Vetting Requirements#Violation Criteria|Violation Criteria]])<br />
:* The '''impact exceeds the effort''' it takes to conform ([[Vetting Requirements#Cost-Benefit Criteria|Effort Criteria]])<br />
<br />
Every extra requirement makes the profile incrementally longer to read, more work to assess, and harder to conform to. Each increment consumes time and attention at every conforming site and likely discourages one more site from conforming. Dropping requirements is a key mission once the initial brainstorming is done.<br />
<br />
:''"Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away." - Antoine de Saint-Exupéry''<br />
<br />
<br />
==Impact Criteria==<br />
The requirement discernably '''impacts the performance''' of the biomarker as expressed in the Claim. <br />
<br />
If it's not impacting the Claim, it's not serving the purpose of the Profile. The Profile Authoring Group should be able to state, for each requirement, the way it impacts the Claim.<br />
<br />
Consider having a line in the Discussion section for each requirement that explains how it impacts performance, even if only a consensus hypothesis. If there is groundwork or literature you can reference that proves the hypothesis, that's even better.<br />
<br />
For each requirement:<br />
* Imagine dropping it and consider the impact on the claim. <br />
* Conversely, would you fail a site that didn't conform to this requirement but conformed to all the rest? If not, it's not critical to meeting the Claim and can be dropped, or moved to the "extra credit" section of non-required recommendations. <br />
<br />
'''Stages''':<br />
* During Stage 0 '''Groundwork''': this is a '''key focus''' since many experiments are intended to specifically '''identify sources of variance''' and their impact.<br />
* During Stage 1 Public Comment: specifically '''ask reviewers''' to identify requirements they feel may not meet the Impact Criteria.<br />
:* '''Before releasing the Public Comment draft''', the Profile Authoring Group should '''review each requirement''' to make sure that someone can briefly state the actual mechanism by which it impacts the claim.<br />
* During Stage 2 Consensus: this is a chance for the Profile Authoring Group members to revisit this question<br />
* During Stage 3 Technical Confirmation: When '''field test sites''' indicate they did not conform to a requirement (or would not in practice), review the reason/opinion they provided. They '''may be challenging whether the requirement has a meaningful impact'''.<br />
<br />
'''Examples''':<br />
* The ability of a staff member to provide a '''professional certification''' document likely does not in itself impact biomarker performance. Consider if there is a particular skill or expertise they may acquire during that certification which would affect biomarker performance. You could require they demonstrate having that skill and perhaps allow a certification record as an example method of demonstration. This also avoids narrowly requiring a specific national certification. <br />
* General '''best practices and safety guidelines''' for imaging are wonderful, but such recommendations are a job already being done (well) by others. The job of QIBA is to deliver accurate, reproducible biomarkers. Consider briefly referencing such best practice guidelines in the informative text of the Profile. But do not burden the profile by including an (incomplete) set of those guidelines as requirements.<br />
* '''Confirming assumptions''' that the claim depends on DOES contribute to achieving the claim if there is a reasonable possibility that the assumptions don't hold at a conforming site. Consider requirements that help sites confirm those assumptions hold locally. E.g. if the Profile performance model has assumed the relationship between the measurements and the ground truth is linear (with a certain slope), and that linearity might vary from site to site, then the Profile may need a requirement to confirm that linearity and slope.<br />
* Sources of variance '''exposed by groundwork''' are a great basis for requirements with proven impact.<br />
* Since technology and practices change over time, it may be appropriate to periodically review profiles and consider adding or removing requirements as existing sources of variance are resolved and new ones emerge.<br />
* An example of an impactful requirement that often gets overlooked is the need to mandate retention of certain DICOM private tags, such as the ''b''-value information for diffusion MR, that otherwise get removed during the anonymization of data in a clinical trial setting.<br />
<br />
==Violation Criteria==<br />
The requirement should be '''violated''' often enough '''in practice''' to be worth addressing. <br />
<br />
If a requirement is confirming something that is ''always'' true, it's not a good use of time and effort. In the extreme, scanning the patient is undeniably a requirement for good measurements and would impact the claim. But realistically, sites don't need us to tell them. It's not a requirement that sites need us to remind them not to violate. <br />
<br />
For requirements that are violated but only very rarely, consider "expected value" (probability * value). If the impact of violation is very high, it may still be worth addressing even if the probability is low. If the impact is also low, it might not be worthwhile to burden everyone with the requirement that only rarely provides a small value.<br />
<br />
Imagine being called in to investigate poor site performance. Focus the requirements on the things that you would reasonably expect to sometimes be the culprit.<br />
<br />
For each requirement, imagine dropping it and estimate how many sites would fail to do it if we didn't tell them. <br />
<br />
'''Stages''':<br />
* During Stage 0 Groundwork: it's OK to initially cast a wide net and include things where you are not sure how often they are violated in practice. <br />
* During Stage 1 '''Public Comment''': specifically '''ask reviewers''' to identify requirements they feel are unlikely violated in practice. Public Comment is our best opportunity to get broad input "from the field". Cast a wide net when circulating the profile.<br />
* During Stage 2 Consensus: this is a chance for the Profile Authoring Group members to incorporate the Public Comment feedback.<br />
* During Stage 3 Technical Confirmation: <br />
:* When field test sites indicate they did not conform to a requirement (or would not in practice), take comfort that clearly the requirement gets violated in practice, thus passing the Violation criteria, ... but you should still confirm the Impact and Cost criteria. <br />
:* Conversely, sites may provide feedback that the requirement addresses something that is never a problem in practice since everyone always conforms. Look into whether it might make sense to drop the requirement, especially if assessment is non-trivial.<br />
<br />
'''Examples''':<br />
* Placing the patient roughly centered laterally when doing head, chest or abdominal CT or MR imaging is standard practice at most/all sites. If the patient is significantly off-center there is likely an unavoidable reason for it. If the profile depends on a tight tolerance for that centering, it might be worth a requirement. Otherwise, consider moving it out of requirements into a section on "Assumptions".<br />
<br />
==Effort Criteria==<br />
The requirement's '''impact exceeds the effort''' it takes to conform.<br />
<br />
The best requirements take minimal effort and yield significant impact. Next best are those that provide a modest impact for a small effort. <br />
<br />
Requirements that have minimal impact but require significant effort to conform and assess should be dropped from the profile. <br />
<br />
Finally, those where the effort and impact are both significant, call for careful consideration. If the level of performance ''after'' dropping the requirement would '''still be good enough''' for the driving clinical tasks, then it is a ''nice-to-have'' not a ''need-to have''. If the clinical task '''depends''' on the requirement being met, then that effort is "the price of admission" but be prepared to concisely document that justification of the effort to implementers. <br />
<br />
For each requirement, discuss your estimate of the "cost-benefit", even if you can't perform groundwork to validate.<br />
<br />
'''Stages''':<br />
* During Stage 0 Groundwork: this is an opportunity to get estimates of the benefit of key requirements.<br />
* During Stage 1 Public Comment: specifically '''ask reviewers''' to identify requirements they feel may be '''burdensome relative to their impact'''.<br />
* During Stage 2 Consensus: this is a chance for the Biomarker Committee members to incorporate the Public Comment feedback.<br />
* During Stage 3 '''Clinically Feasible Confirmation,''' formerly '''Technical Confirmation''': <br />
:* When field test sites actually perform the Profile, you will get '''concrete values for the cost''' (effort) of conforming to each requirement. If it exceeds your estimates, re-assess whether the requirement should be kept.<br />
:* If sites indicate they did not conform to a requirement (or would not in practice), review the reason/opinion they provided. They may be challenging whether the requirement cost is warranted.<br />
<br />
'''Strategies''':<br />
* '''Remove''': If you have enough room in your "performance budget" (between the performance delivered by the Profile and the performance needed to support the clinical tasks), consider dropping the requirement and degrading the claim. Implementers will appreciate the easier profile today and you can consider adding the requirement in a future edition.<br />
* '''Relax''': Consider whether there's a way to split the difference and relax both the requirement and the claim a bit to make it more tolerable. In some cases, meeting 50% of the requirement might provide 80% of the impact.<br />
* '''Devise''': If the assessment procedure is burdensome, see if you can devise a different way to assess conformance that is less "costly". <br />
* '''Justify''': Document clearly in the Profile why the requirement (and associated effort) are unavoidable to achieve adequate performance, so sites see why they HAVE to do it.<br />
<br />
'''Examples''':<br />
* Requiring a '''daily QC procedure''' would likely represent excessive effort for a minimal gain when compared to a weekly or monthly QC check.<br />
<br />
<br />
===See Also===<br />
<br />
* Guidance on '''[[Expressing Requirements]]'''</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Vetting_Requirements&diff=19639Vetting Requirements2024-01-19T19:35:34Z<p>Jlisiecki: /* Impact Criteria */</p>
<hr />
<div>{{TOCright}}<br />
<br />
Profile Requirements '''tell Vendors and Site Staff what they must do''' to claim conformance with the Profile.<br />
<br />
<br />
The point of conformance to a Profile is '''to achieve the technical performance stated in the Claim'''.<br />
<br />
So, ''each'' requirement in a Profile should meet '''three criteria''':<br />
:* It discernably '''impacts the performance''' of the biomarker ([[Vetting Requirements#Impact Criteria|Impact Criteria]])<br />
:* It is '''violated''' often enough '''in practice''' to be worth addressing ([[Vetting Requirements#Violation Criteria|Violation Criteria]])<br />
:* The '''impact exceeds the effort''' it takes to conform ([[Vetting Requirements#Cost-Benefit Criteria|Effort Criteria]])<br />
<br />
Every extra requirement makes the profile incrementally longer to read, more work to assess, and harder to conform to. Each increment consumes time and attention at every conforming site and likely discourages one more site from conforming. Dropping requirements is a key mission once the initial brainstorming is done.<br />
<br />
:''"Perfection is achieved, not when there is nothing more to add, but when there is nothing left to take away." - Antoine de Saint-Exupéry''<br />
<br />
<br />
==Impact Criteria==<br />
The requirement discernably '''impacts the performance''' of the biomarker as expressed in the Claim. <br />
<br />
If it's not impacting the Claim, it's not serving the purpose of the Profile. The Profile Authoring Group should be able to state, for each requirement, the way it impacts the Claim.<br />
<br />
Consider having a line in the Discussion section for each requirement that explains how it impacts performance, even if only a consensus hypothesis. If there is groundwork or literature you can reference that proves the hypothesis, that's even better.<br />
<br />
For each requirement:<br />
* Imagine dropping it and consider the impact on the claim. <br />
* Conversely, would you fail a site that didn't conform to this requirement but conformed to all the rest? If not, it's not critical to meeting the Claim and can be dropped, or moved to the "extra credit" section of non-required recommendations. <br />
<br />
'''Stages''':<br />
* During Stage 0 '''Groundwork''': this is a '''key focus''' since many experiments are intended to specifically '''identify sources of variance''' and their impact.<br />
* During Stage 1 Public Comment: specifically '''ask reviewers''' to identify requirements they feel may not meet the Impact Criteria.<br />
:* '''Before releasing the Public Comment draft''', the Profile Authoring Group should '''review each requirement''' to make sure that someone can briefly state the actual mechanism by which it impacts the claim.<br />
* During Stage 2 Consensus: this is a chance for the Profile Authoring Group members to revisit this question<br />
* During Stage 3 Technical Confirmation: When '''field test sites''' indicate they did not conform to a requirement (or would not in practice), review the reason/opinion they provided. They '''may be challenging whether the requirement has a meaningful impact'''.<br />
<br />
'''Examples''':<br />
* The ability of a staff member to provide a '''professional certification''' document likely does not in itself impact biomarker performance. Consider if there is a particular skill or expertise they may acquire during that certification which would affect biomarker performance. You could require they demonstrate having that skill and perhaps allow a certification record as an example method of demonstration. This also avoids narrowly requiring a specific national certification. <br />
* General '''best practices and safety guidelines''' for imaging are wonderful, but such recommendations are a job already being done (well) by others. The job of QIBA is to deliver accurate, reproducible biomarkers. Consider briefly referencing such best practice guidelines in the informative text of the Profile. But do not burden the profile by including an (incomplete) set of those guidelines as requirements.<br />
* '''Confirming assumptions''' that the claim depends on DOES contribute to achieving the claim if there is a reasonable possibility that the assumptions don't hold at a conforming site. Consider requirements that help sites confirm those assumptions hold locally. E.g. if the Profile performance model has assumed the relationship between the measurements and the ground truth is linear (with a certain slope), and that linearity might vary from site to site, then the Profile may need a requirement to confirm that linearity and slope.<br />
* Sources of variance '''exposed by groundwork''' are a great basis for requirements with proven impact.<br />
* Since technology and practices change over time, it may be appropriate to periodically review profiles and consider adding or removing requirements as existing sources of variance are resolved and new ones emerge.<br />
* An example of an impactful requirement that often gets overlooked is the need to mandate retention of certain DICOM private tags, such as the ''b''-value information for diffusion MR, that otherwise get removed during the anonymization of data in a clinical trial setting.<br />
<br />
==Violation Criteria==<br />
The requirement should be '''violated''' often enough '''in practice''' to be worth addressing. <br />
<br />
If a requirement is confirming something that is ''always'' true, it's not a good use of time and effort. In the extreme, scanning the patient is undeniably a requirement for good measurements and would impact the claim. But realistically, sites don't need us to tell them. It's not a requirement that sites need us to remind them not to violate. <br />
<br />
For requirements that are violated but only very rarely, consider "expected value" (probability * value). If the impact of violation is very high, it may still be worth addressing even if the probability is low. If the impact is also low, it might not be worthwhile to burden everyone with the requirement that only rarely provides a small value.<br />
<br />
Imagine being called in to investigate poor site performance. Focus the requirements on the things that you would reasonably expect to sometimes be the culprit.<br />
<br />
For each requirement, imagine dropping it and estimate how many sites would fail to do it if we didn't tell them. <br />
<br />
'''Stages''':<br />
* During Stage 0 Groundwork: it's OK to initially cast a wide net and include things where you are not sure how often they are violated in practice. <br />
* During Stage 1 '''Public Comment''': specifically '''ask reviewers''' to identify requirements they feel are unlikely violated in practice. Public Comment is our best opportunity to get broad input "from the field". Cast a wide net when circulating the profile.<br />
* During Stage 2 Consensus: this is a chance for the Biomarker Committee members to incorporate the Public Comment feedback.<br />
* During Stage 3 Technical Confirmation: <br />
:* When field test sites indicate they did not conform to a requirement (or would not in practice), take comfort that clearly the requirement gets violated in practice, thus passing the Violation criteria, ... but you should still confirm the Impact and Cost criteria. <br />
:* Conversely, sites may provide feedback that the requirement addresses something that is never a problem in practice since everyone always conforms. Look into whether it might make sense to drop the requirement, especially if assessment is non-trivial.<br />
<br />
'''Examples''':<br />
* Placing the patient roughly centered laterally when doing head, chest or abdominal CT or MR imaging is standard practice at most/all sites. If the patient is significantly off-center there is likely an unavoidable reason for it. If the profile depends on a tight tolerance for that centering, it might be worth a requirement. Otherwise, consider moving it out of requirements into a section on "Assumptions".<br />
<br />
==Effort Criteria==<br />
The requirement's '''impact exceeds the effort''' it takes to conform.<br />
<br />
The best requirements take minimal effort and yield significant impact. Next best are those that provide a modest impact for a small effort. <br />
<br />
Requirements that have minimal impact but require significant effort to conform and assess should be dropped from the profile. <br />
<br />
Finally, those where the effort and impact are both significant, call for careful consideration. If the level of performance ''after'' dropping the requirement would '''still be good enough''' for the driving clinical tasks, then it is a ''nice-to-have'' not a ''need-to have''. If the clinical task '''depends''' on the requirement being met, then that effort is "the price of admission" but be prepared to concisely document that justification of the effort to implementers. <br />
<br />
For each requirement, discuss your estimate of the "cost-benefit", even if you can't perform groundwork to validate.<br />
<br />
'''Stages''':<br />
* During Stage 0 Groundwork: this is an opportunity to get estimates of the benefit of key requirements.<br />
* During Stage 1 Public Comment: specifically '''ask reviewers''' to identify requirements they feel may be '''burdensome relative to their impact'''.<br />
* During Stage 2 Consensus: this is a chance for the Biomarker Committee members to incorporate the Public Comment feedback.<br />
* During Stage 3 '''Clinically Feasible Confirmation,''' formerly '''Technical Confirmation''': <br />
:* When field test sites actually perform the Profile, you will get '''concrete values for the cost''' (effort) of conforming to each requirement. If it exceeds your estimates, re-assess whether the requirement should be kept.<br />
:* If sites indicate they did not conform to a requirement (or would not in practice), review the reason/opinion they provided. They may be challenging whether the requirement cost is warranted.<br />
<br />
'''Strategies''':<br />
* '''Remove''': If you have enough room in your "performance budget" (between the performance delivered by the Profile and the performance needed to support the clinical tasks), consider dropping the requirement and degrading the claim. Implementers will appreciate the easier profile today and you can consider adding the requirement in a future edition.<br />
* '''Relax''': Consider whether there's a way to split the difference and relax both the requirement and the claim a bit to make it more tolerable. In some cases, meeting 50% of the requirement might provide 80% of the impact.<br />
* '''Devise''': If the assessment procedure is burdensome, see if you can devise a different way to assess conformance that is less "costly". <br />
* '''Justify''': Document clearly in the Profile why the requirement (and associated effort) are unavoidable to achieve adequate performance, so sites see why they HAVE to do it.<br />
<br />
'''Examples''':<br />
* Requiring a '''daily QC procedure''' would likely represent excessive effort for a minimal gain when compared to a weekly or monthly QC check.<br />
<br />
<br />
===See Also===<br />
<br />
* Guidance on '''[[Expressing Requirements]]'''</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Process&diff=19638Process2024-01-19T19:32:44Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
{{TOCright}}<br />
QIBA ''' ''industrializes'' biomarkers''' by selecting biomarkers ready for industrialization, investigating underlying sources of variance and practical impediments to their use, and drafting specification documents ("Profiles") to help vendors and healthcare providers overcome those impediments and sources of variance.<br />
<br />
The details of how those steps are carried out is described here. The [[Process Coordinating Committee]] manages this content. Comments are welcome. <br />
<br />
==Committee Procedures==<br />
<br />
* [[Committee Procedures]]<br />
** [[Voting Privileges]]<br />
* [[Committee Organization]]<br />
** [[Committee Sunset Process]]<br />
* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]<br />
* [[Media:QIBA Conflict of Interest (COI) Policy-2021.10.28.pdf|QIBA Conflict of Interest (COI) Policy]]<br />
<br />
==Profile Creation==<br />
<br />
===Guidance===<br />
* '''[[How to Write a Profile]]'''<br />
:* [[QIBA Profile Template]]<br />
:* [[Claim Guidance]]<br />
:* [[Vetting Requirements]]<br />
:* [[Expressing Requirements]]<br />
:* [[Assessment Procedure Guidance]]<br />
:* [[Profile Editions]]<br />
* [[Review Process]]<br />
* [[Public Comment Process]]<br />
* [[Publication Process]]<br />
<br />
===Process Steps===<br />
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]<br />
<br />
====Getting to Stage 1: Public Comment====<br />
:* [[Selection Process|Submit Proposals]]<br />
:* [[Selection Process|Evaluate and Approve Proposals]]<br />
:* Start Drafting the Profile<br />
:** See '''[[How to Write a Profile]]''' including specific editing guidelines<br />
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]<br />
:* [[Groundwork Process|Initiate/Conduct Groundwork]]<br />
:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment<br />
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft<br />
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]<br />
<br />
====Getting to Stage 2: Consensus====<br />
:* [[Public Comment Process|Collect & Collate Public Comments]]<br />
:* Reach Consensus on resolution for all comments<br />
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile<br />
:* You have reached Stage 2<br />
<br />
====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====<br />
:* Recruit Sites to Field Test the Profile<br />
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]<br />
:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile<br />
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile<br />
:* You have reached Stage 3<br />
<br />
====Getting to Stage 4: Claim Confirmed====<br />
:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)<br />
:* 4b. Recruit sites to follow the Profile and assess site performance per 4a<br />
:* 4c. Analyze Site Performance Data and assess against Profile Claim<br />
:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile<br />
:* You have reached Stage 4<br />
<br />
====Profile Maintenance====<br />
:* [[Maintenance Process|Accept and Resolve Change Proposals]]<br />
:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]<br />
<br />
====Profile Retirement====<br />
:* [[Retirement Process|Review for Retirement]]<br />
<br />
==Groundwork Projects and Funding==<br />
[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.<br />
<br />
* [[Groundwork Process]]<br />
**[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]<br />
* Funding Submission Process<br />
* Evaluation and Selection Process<br />
**[[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]<br />
* Publication of Results - discuss where, how, level of detail, embargo period (6 months from completion of project?), extension requests, completion=submission of report, actual posting/publication can be later<br />
<br />
==Conformance==<br />
* [[Profile Conformance]]<br />
:* [[QIBA Conformance Statement Template]]<br />
* [[QIBA Profile Conformance]]<br />
<br />
==See Also==<br />
* '''[[How To's]]''' for this Wiki<br />
* [[:Category:Templates|Wiki Page Templates]]<br />
<br />
* [[Profile Editions]]<br />
* [[Change Tracking and File Naming]]<br />
* [[Clinical Trial Planning]]<br />
<br />
* [[Orphan Documents]]<br />
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Review_Process&diff=19637Review Process2024-01-19T17:37:54Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<br />
__NOTOC__<br />
Profiles are reviewed/approved by their parent Profile Authoring Group at [[QIBA Profile Stages|each Stage]]:<br />
* The review/approval steps are the same for each stage, but the '''[[QIBA Profile Stages|criteria differ]]''' <br />
* The '''[[Public Comment Process|Public Comment Review]]''' is another process that specifically covers soliciting and resolving comments that can come from beyond the Committee.<br />
<br />
<br />
Remember, this is the QA point for your work. It doesn't have to be perfect. '''It does have to be good'''.<br />
<br />
==Review (Profile Authoring Group)==<br />
The following review process is strongly recommended, but Profile Authoring Groups are not required to follow this specific process.<br />
* ''Editor'' of the Profile requests content review once they feel work on the current stage has been completed<br />
* ''Profile Authoring Group'' assigns/'''recruits reviewers''' for Profile sections<br />
** Ideally each section should be covered by more than one reviewer<br />
** Reviewing assignments can be divided up any way that is convenient<br />
** It is helpful to have some reviewers read through the profile in its entirety (finds inconsistencies/gaps)<br />
* ''Reviewers'' check the Profile meets the '''[[QIBA Profile Stages|criteria for the stage]]''' as well as '''[[How_to_Write_a_Profile#Follow_Profile_Writing_Guidelines|guidelines for clarity/quality]]''' <br />
** A two week window for the reviewers to do their work is suggested<br />
* ''Reviewers'' '''report back''' to the Profile Authoring Group<br />
* ''Authors and Profile Authoring Group'' resolve any questions/comments/clarifications raised by the reviewers<br />
* ''Co-chair'' accepts a motion to send the document to ballot<br />
<br />
==Approve (Profile Authoring Group)==<br />
The main purpose of '''Profile Authoring Group''' approval is to '''confirm that all the detailed contents are correct, and the Profile meets the criteria''' for the stage.<br />
<br />
* ''Profile Authoring Group'' submits the '''Profile document''' and, if approving for a stage after Public Comment, the '''[[QIBA Profile Stages|supporting document for that stage]]'''<br />
* ''Profile Authoring Group'' circulates a '''[[Committee_Procedures#Email_Ballot|Ballot]]''' asking Profile Authoring Group members to approve that the content of the '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
** The Profile document and supporting document are attached to or linked from the ballot<br />
** The ballot period should be 2-5 weeks (typically 30 days) to allow time to review the full Profile text<br />
** In the case of approving to publish for Public Comment, it is acceptable to instead hold a vote during a meeting.<br />
* ''Profile Authoring Group members'' review the profile and supporting document and confirm '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
* ''Profile Authoring Group'' reviews and ratifies the '''[[Committee_Procedures#Email_Ballot|Ballot]]''' results <br />
* ''Profile Authoring Group'' reviews any contentious ballot comment resolutions</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Selection_Process&diff=19636Selection Process2024-01-19T17:36:40Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
Few imaging biomarkers have reached everyday clinical use. The problem isn't a lack of candidates. There is an enormous number of potential imaging biomarkers.<br />
<br />
QIBA's job is to identify a biomarker that is sufficiently robust, proven and understood to be ready for QIBA to help bridge that last mile.<br />
<br />
QIBA has limited resources to spread across the groundwork and profiling work of the Biomarker Committees so they must be selected carefully. <br />
<br />
==Process==<br />
[[Committees|Coordinating Committees]] prepare proposals that are submitted to the [[Steering Committee]] for approval.<br />
<br />
The Steering Committee evaluates the proposals on a number of criteria and considerations, and '''[[Committee_Procedures#Voting|votes]]''' on whether to approve.<br />
<br />
If approved, a [[Committee Organization|new Biomarker Committee]] is typically formed, although the work could be assigned to an [[Committees|existing Biomarker Committee]]. <br />
<br />
QIBA Leadership may also propose a new biomarker for consideration by the modality-specific Coordinating Committee. This would follow the same review process and final Steering Committee approval.<br />
<br />
<br />
==Criteria==<br />
:* Transformational <br />
::* Addresses a significant medical biomarker need with a likely considerable impact on public health, and addresses a critical gap in the biomarkers qualification/validation process.<br />
:* Translational <br />
::* Will likely result in significant improvement in the development, approval, or delivery of care to patients.<br />
:* Feasible <br />
::* An idea or program whose end goals can likely be achieved in a specific timeframe and that has a reasonable prospect of producing the expected outcomes; ideal programs are those which could result in regulatory qualification of a biomarker in three years. <br />
:* Practical <br />
::* Leverages preexisting resources (e.g., intellectual capital, personnel, facilities, specimens, reagents, data) wherever possible; warrants access to RSNA resources and support.<br />
:* Collaborative <br />
::* Would uniquely benefit from the multi-stakeholder composition and approach of QIBA and could be feasibly executed under its policies e.g. resulting in extension or adoption in product development among hardware, software, or imaging agents. The biomarker has the support of the stakeholder community with the organizational impetus to sustain continued efforts.<br />
<br />
(See [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria 2014]])<br />
<br />
==Considerations==<br />
<br />
TBA</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19635Committee Procedures2024-01-19T17:32:37Z<p>Jlisiecki: /* Consensus Process */</p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot<br />
* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''Profile Authoring Group scribe'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, the Profile Authoring Groups actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should consider raising the issue with the chair(s) of the Profile Authoring Group.<br />
<br />
==Profile Authoring Group Leadership==<br />
*Profile Authoring Groups are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, groups are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19634Committee Procedures2024-01-19T17:31:55Z<p>Jlisiecki: /* Consensus Process */</p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot<br />
* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''Profile Authoring Group scribe'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should consider raising the issue with the chair(s) of the Profile Authoring Group.<br />
<br />
==Profile Authoring Group Leadership==<br />
*Profile Authoring Groups are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, groups are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19633Committee Procedures2024-01-19T17:30:37Z<p>Jlisiecki: /* Committee Leadership */</p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot<br />
* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''Profile Authoring Group scribe'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Profile Authoring Group Leadership==<br />
*Profile Authoring Groups are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, groups are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19632Technical Confirmation Process2024-01-19T17:27:08Z<p>Jlisiecki: </p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g., if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Profile Authoring Group.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Profile Authoring Group members may have personal contacts they can explore.<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Profile Authoring Group members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc.) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''Profile Authoring Group Leadership''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Profile Authoring Group''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet.<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either: <clarify with new wording><br />
** refer the document for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19631Technical Confirmation Process2024-01-19T17:23:56Z<p>Jlisiecki: /* Planning & Recruitment */</p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g. if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Biomarker Committee.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Committee members may have personal contacts they can explore<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Biomarker Committee members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc.) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and QIBA Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''Profile Authoring Group Leadership''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Profile Authoring Group''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either: <clarify with new wording><br />
** refer the document for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19630Technical Confirmation Process2024-01-19T17:21:26Z<p>Jlisiecki: /* Collecting & Processing Feedback */</p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g. if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Biomarker Committee.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Committee members may have personal contacts they can explore<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Biomarker Committee members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and QIBA Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''Profile Authoring Group Leadership''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Profile Authoring Group''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either: <clarify with new wording><br />
** refer the document for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19629Technical Confirmation Process2024-01-19T17:19:58Z<p>Jlisiecki: /* Collecting & Processing Feedback */</p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g. if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Biomarker Committee.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Committee members may have personal contacts they can explore<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Biomarker Committee members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and QIBA Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''Profile Authoring Group Leadership''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Profile Authoring Group''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Profile Authoring Group'''), either: <clarify with new wording><br />
** refer the document for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader/RSNA Staff)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19628Technical Confirmation Process2024-01-19T17:18:51Z<p>Jlisiecki: /* Collecting & Processing Feedback */</p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g. if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Biomarker Committee.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Committee members may have personal contacts they can explore<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Biomarker Committee members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and QIBA Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''Profile Authoring Group Leadership''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Profile Authoring Group''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Profile Authoring Group''')<br />
* Record comment resolutions in spreadsheet<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Biomarker Committee'''), either: <clarify with new wording><br />
** refer the document to the Modality Committee for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader/RSNA Staff)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Technical_Confirmation_Process&diff=19627Technical Confirmation Process2024-01-19T17:17:39Z<p>Jlisiecki: /* Planning & Recruitment */</p>
<hr />
<div>{{TOCright}}<br />
The '''[[QIBA Profile Stages#Stage 3: Clinically Feasible (formerly Technically Confirmed)|Clinically Feasible (formerly Technical Confirmation) Stage]]''' '''confirms it is practical for sites to perform the technical requirements''' to conform to the Profile.<br />
<br />
Users in the field (clinical oncologists, imaging scientists, pharma, CRO’s, imaging vendors, software providers, etc.) attempt to conform to the Profile and provide feedback on the practicality of the requirements (and the usability of the document).<br />
<br />
Whereas the preceding [[QIBA_Profile_Stages|Public Comment Stage]] collected feedback based on people reading the Profile document itself, this stage seeks '''feedback on how well it works in a pilot implementation'''. As such, comments are solicited specifically from those that have used it and only those that have used it. <br />
<br />
Considerations:<br />
* Profile authors have written requirements they believe are within the range of current reasonable practice in clinical use.<br />
* Sites are asked to consider, as they generate the biomarker according to the Profile, whether they would find the requirements '''practical in routine work'''.<br />
:* Sites do not need to commit to using the Profile for all routine work going forward (although it would certainly be positive feedback if they chose to).<br />
* Sites are strongly encouraged to try to meet all the requirements<br />
:* If the site is not comfortable using the procedures for '''patient scans''', they can scan a phantom and note in their feedback that they used a phantom, and what details of the procedure made them uncomfortable.<br />
::* If sites are uncomfortable meeting certain requirements with patients, that would make it hard to deploy the Profile so the Biomarker Committee may need to consider revising that requirement or better explaining/justifying it for sites. <br />
:* Try to follow all requirements, even if scanning a phantom.<br />
::* E.g. if the Profile has required breathing instructions, giving them to the phantom may help a site realize that the wording is incompatible with their preferred practice, or the text is poorly written, etc.<br />
:* If the site is '''unable to conform''' to any requirements, comments on the nature of their difficulty or their reason for not conforming are very helpful to the Biomarker Committee.<br />
<br />
<br />
The following Procedures list what is done ('''by whom''').<br />
<br />
==Planning & Recruitment==<br />
<br />
* Identify sites/people that will participate in the field test ('''Field Test Leader''')<br />
** At least 3 sites are needed to get reasonable confirmation of results<br />
** Often Committee members may have personal contacts they can explore<br />
*** "External" sites should be recruited to bring "fresh eyes" to better assess the clarity of the profile and bring different assumptions about routine practice for this biomarker. <br />
*** Sites where Biomarker Committee members work may be easier to recruit since there is an existing champion, but they should make a point of engaging other fresh eyes (techs, physicists, radiologists, etc) and possibly stepping back when it comes time to perform the actual field test.<br />
*** It can be helpful to have a mix of large academic centers, large hospitals, and smaller hospitals or imaging centers.<br />
*** International feedback is desirable due to variations in practice and language; and QIBA Profiles are intended to be internationally applicable.<br />
**** ''<TODO: Add links to contacts for Europe, Japan, US, etc.>''<br />
*** Core Labs can be effective field testers since they have experience with a variety of site practices and measurement needs<br />
** It may also be useful to call for volunteer sites <br />
** If a profile covers multiple organs/cases, the goal is to test all of them. <br />
*** If each site tests all organs/cases, test coverage is simplest; however, it is acceptable for sites to test subsets as long as everything gets covered.<br />
<br />
* Prepare field test materials/documents ('''Profile Authoring Group''')<br />
** Cover Letter<br />
*** Many times, a meeting is arranged between members of the field test site and members of the Profile Authoring Group to describe the purpose of the field test and answer any questions the site may have.<br />
**** Consider recording the questions/answers since they may point to useful clarifications in the Profile<br />
**** If a meeting is not possible, the information may be conveyed in a Cover Letter.<br />
** Site Details<br />
*** To collect basic site information and prompt general feedback, consider the [[Media:QIBA User Feedback Template-2011.01.doc| QIBA Trial Implementation Feedback Template]]<br />
** Profile Requirements<br />
*** Generally, the Profile Checklists are the core document.<br />
*** The full Profile should also be made available as some sites will find it useful to have the context provided in the Overview and the explanations/clarifications in the Discussion sections. <br />
** Feedback Forms<br />
*** One effective approach is to add two columns to the conformance checklists, to indicate for each requirement whether the site conformed to the requirement, and whether they found the requirement practical for routine use. <br />
*** Additional General comments can be collected on a form similar to Public Comment.<br />
<br />
==Collecting & Processing Feedback==<br />
<br />
* Provide field test materials (see above) to each site ('''BC Leadership''' or '''RSNA Staff''')<br />
* Email feedback to Field Test Leader ('''Commenters''')<br />
<br />
''<TODO More cleanup>''<br />
<br />
* Collate all Feedback comments into a '''[https://docs.google.com/spreadsheets/d/1JW-_iJ7vTJvCf1-y4wsxZ_coO8Po2zWqMNDNrBVyUXM/edit?usp=sharing Feedback Resolution spreadsheet]''' ('''Field Test Leader''')<br />
** See the Instructions sheet in the spreadsheet for details.<br />
* Assess test coverage ('''Biomarker Committee''')<br />
** Were all requirements tested. If coverage is incomplete <including organ coverage>, consider dropping the requirement or document the rationale for finding it technically confirmed in the absence of testing. <some sites may have done less than scheduled/intended><might not have needed coils on hand><BC notes lack of coverage and rationale for how to proceed><are there substantive practical issues, if not OK for Stage 3. Are there substantive performance issues, comes up in Stage 4><br />
* Review comments, making changes to the document as needed ('''Biomarker Committee''')<br />
* Record comment resolutions in spreadsheet<br />
<br />
<br />
(Cmte can decide if the full procedure has been "adequately" tested). Sites not doing requirement X is key feedback.<br />
* (Doing clinical patients exposes nuances, <br />
* <Committee may be faced with a response where none of the sites were comfortable executing the profile on patients and responded based on reading. In this case, the committee has done two public comments and no technical confirmation and has sites saying they are not comfortable with the profile. Should the committee advance the profile in this case? That would be pretty negative feedback><br />
* <Profiles are generally written not to be unusual procedures><NOTE Didn't conform isn't a killer, it's the information we are trying to get. Might be better procedures, or might be superfluous><br />
* <"Not routine, but can" also useful feedback - can do it but we really have to make the case for the value><br />
<br />
<br />
* Vote on next step for the document ('''Biomarker Committee'''), either: <clarify with new wording><br />
** refer the document to the Modality Committee for Technically Confirmed publication<br />
** conduct another round of field test on revised document<br />
** place the document into inactive status<br />
<br />
<br />
* Post '''Feedback Resolution spreadsheet''', revised document to the '''[[Comment Resolutions|Wiki]]''' ('''Field Test Leader/RSNA Staff)<br />
* If profile requirements didn't change significantly, test sites may be able to claim conformance.<br />
<br />
<When the TC 2020 version comes out, and a site tried the Consensus 2020 but only missed one requirement. Then the BC relaxed that requirement in the TC2020 (or 2021 explain ) draft, it would be nice if there was "change tracking" so they could see that now they would pass. Could have a "change tracked" document between each draft (but just the preceding, not all the combos, you have to step through the changes of history) Practically, we can point them to the newest, and maybe provide one "generation" of change track><br />
<br />
==See Also==<br />
:** An earlier alternative writeup - [[QIBA Protocol/Profile Implementation Feedback Process]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Publication_Process&diff=19626Publication Process2024-01-19T17:12:44Z<p>Jlisiecki: </p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
When a Profile has been [[Review Process|reviewed and approved]] for publication <br />
<br />
* ''Authors'' <br />
** inform RSNA Staff that a profile is ready for publication<br />
** provide RSNA Staff with the Word document of the Profile<br />
** provide RSNA Staff with the [[QIBA_Profile_Stages#Stage_2:_Consensus|Support Document]] (Excel, Google Sheet, etc.)<br />
*** there is no support document required to publish for the Public Comment Stage<br />
<br />
<br />
* ''Profile Authoring Group''<br />
** checks the minutes of the Biomarker and Coordinating Committees to confirm the approval results<br />
** checks the title page and document title match the current '''[[Profile Editions|stage and Profile naming guidance]]'''<br />
** generates a PDF of the Profile document provided by the authors<br />
** uploads the PDF document to the Wiki (Tip: [[Special:Upload|Upload file]])<br />
** adds a link to the [[Profiles]] page in the appropriate stage (Tip: copy an existing link to get the format)<br />
** removes the old link for this Profile in the prior stage<br />
** links to the [[QIBA_Profile_Stages#Stage_2:_Consensus|Support Document]] from the corresponding row in the [[Comment Resolutions]] page<br />
<br />
<br />
* ''Authors'' may also want to publicize the profile by:<br />
** drafting an executive summary paper for submission to a relevant journal<br />
** submitting a letter to the editor of a relevant journal<br />
** notifying trade news such as ''Aunt Minnie''<br />
** posting to mailing lists of relevant professional societies or interest groups</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19625Committee Procedures2024-01-19T17:05:44Z<p>Jlisiecki: /* Email Ballot */</p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot<br />
* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''Profile Authoring Group scribe'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Committee Leadership==<br />
* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19624Committee Procedures2024-01-19T17:05:29Z<p>Jlisiecki: /* Email Ballot */</p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''Profile Authoring Group scribe'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''Profile Authoring Group scribe'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with the Profile Authoring Group scribe or Chairs, and if they are found to be eligible will be sent a ballot<br />
* ''Profile Authoring Group scribe'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''RSNA Staff'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Committee Leadership==<br />
* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19623Committee Procedures2024-01-19T17:04:13Z<p>Jlisiecki: </p>
<hr />
<div><font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''RSNA Staff'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''RSNA Staff'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with RSNA Staff and if they are found to be eligible will be sent a ballot<br />
* ''RSNA Staff'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''RSNA Staff'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Committee Leadership==<br />
* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19622Committee Procedures2024-01-19T17:03:00Z<p>Jlisiecki: /* Voting */</p>
<hr />
<div><br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "Profile Authoring Group scribe'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor.<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote.<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes are desirable<br />
* ''Profile Authoring Group scribe'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes.<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by the ''Profile Authoring Group scribe''.<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''RSNA Staff'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''RSNA Staff'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with RSNA Staff and if they are found to be eligible will be sent a ballot<br />
* ''RSNA Staff'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''RSNA Staff'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Committee Leadership==<br />
* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Committee_Procedures&diff=19621Committee Procedures2024-01-19T17:01:04Z<p>Jlisiecki: /* Meeting Procedures */</p>
<hr />
<div><br />
==Meeting Procedures==<br />
The goal is group consensus and the input and endorsement of imaging community stakeholders on major decisions.<br />
<br />
* When participation at a given meeting is not open to all committee members, (e.g., it takes place at an '''“invitation-only” face-to-face event and remote access is not provided for the committee meeting'''), that meeting '''will not be considered an official meeting''' of that committee. No official decisions will be made and attendance will not count toward or against voting privileges. <br />
** The chair will need to ensure that attendance records are captured and submitted to the Profile Authoring Group members.<br />
<br />
A record of committee decisions and rationale is necessary to be effective and learn. <br />
* ''Profile Authoring Group scribe'' records minutes (call summaries) for meetings <br />
* ''Chairs'' are strongly encouraged to support Profile Authoring Group scribes by reviewing/correcting the draft minutes circulated <br />
* ''Profile Authoring Group Chairs'' maintain '''[[Committees|rosters of the members of each committee]]''' and their participation. Those details are used to determine which members currently have '''[[Voting Privileges]]'''<br />
** ''Members'' who believe their attendance record is in error should contact Profile Authoring Group Chairs.<br />
<br />
==Voting==<br />
Most committee work doesn't need a vote. At the discretion of committee chairs and members, however, decisions can be put to a vote during meetings. This also facilitates recording key decisions in the minutes.<br />
<br />
* ''Chairs'' accept motions, seconds, discussion, and then call for a vote<br />
** At its simplest, the ''Chair'' asks for objections, then asks for abstentions, and "RSNA Staff'' notes those names. The rest of those present with voting privileges can safely be assumed to have voted in favor<br />
* ''Members'' who have '''[[Voting Privileges]]''' count towards quorum and may vote<br />
* ''Chairs'' resolve negative votes and large numbers of abstentions per the '''[[Committee Procedures#Consensus Process|consensus process]]'''<br />
** details of the resolution discussion in the minutes is desirable<br />
* ''RSNA Staff'' records the motion, the tally of those against/abstaining/in-favor, and the details of negative votes in the minutes<br />
** If attendance, eligibility and quorum cannot be determined during the meeting, vote results will be ratified after the call and entered into the minutes by ''RSNA Staff''<br />
<br />
==Email Ballot==<br />
Substantive decisions, such as whether a Profile is advanced to the next stage, are put to ballot. This allows more deliberation on the subject material than a vote in committee.<br />
<br />
A committee may initiate an email ballot on a document by approving a motion to do so (i.e. officially deciding the document is ready for ballot). Alternatively, Chairs may initiate email ballots at their own discretion after assuring appropriate discussion and review by the committee, and if there are multiple chairs then a simple majority of the chairs must approve the action.<br />
<br />
* ''Chairs'' submit the ballot question and length of the ballot period to RSNA Staff<br />
** The ballot period may be specified by the particular procedure that calls for a ballot<br />
** The ballot period is generally not less than 14 days to allow adequate time to review the material and vote<br />
** If reviewing lengthy documents or collecting feedback within member organizations is involved 30 days is suggested for the ballot period<br />
* ''RSNA Staff'' emails the ballot to all members with '''[[Voting Privileges]]''' on the committee making the decision<br />
* ''RSNA Staff'' emails a notification of ineligibility to the rest of the members of the committee making the decision <br />
** Members who do not have Voting Privileges will thus be aware of the ballot and are still permitted to submit comments<br />
** Members who believe their attendance record is in error can review of their attendance with RSNA Staff and if they are found to be eligible will be sent a ballot<br />
* ''RSNA Staff'' compiles the ballot responses and comments for the Chairs<br />
** o At the discretion of the Chairs, comments submitted by non-voting members may be stricken<br />
* ''Chairs'' ratify the resulting tally and comments within a reasonable period of time (preferably in the next committee meeting) per the consensus process<br />
* ''RSNA Staff'' records resolution results/rationale in the minutes<br />
<br />
==Quorum==<br />
For a vote or ballot to be valid, at least 50% of those with voting privileges must have participated (by either voting in favor, objecting, or abstaining).<br />
<br />
==Consensus Process==<br />
As a group setting standards on behalf of a community, QIBA Committees actively seek to pursue Consensus.<br />
<br />
* a vote/ballot passes with a quorum of votes and a majority of votes in favor, but<br />
** a '''negative vote or votes should result in subsequent discussion''' to<br />
*** '''understand the reason''' for such (a) negative vote(s) and '''attempt to find a compromise or resolution'''; associated edits to the document under ballot do not typically require re-balloting<br />
** a '''large number of abstentions''' may also warrant discussion; it may indicate many people have:<br />
*** misgivings<br />
*** not been able to adequately evaluate the question<br />
<br />
Participants concerned that a reasonable attempt at consensus has not been made should first consider raising the issue with the chair of the Biomarker Committee. Failing that, the chairs of the Coordinating Committee or QIBA Steering Committee may be consulted.<br />
<br />
==Committee Leadership==<br />
* Coordinating Committees, Biomarker Committees and Task Forces are encouraged to have 2 or 3 leaders who are preferably drawn from diverse backgrounds (Researchers, Clinicians, Physicists, Vendors, Regulators, etc.) <br />
** If not possible, committees are permitted to have some concentration but should discuss plans to expand the breadth of stakeholder representation at least annually<br />
<br />
==See Also==<br />
* [[Committees|QIBA Committees]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19620Public Comment Process2024-01-19T16:57:44Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to a public comment form (Google forms are recommended for ease of data capture) - ''see example'': [[Image:public comment form.jpg |1200px]]<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope)<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19619Work Product for Review2024-01-19T16:56:40Z<p>Jlisiecki: /* Comment Submission */</p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* ** provide a link to a public comment form (Google forms are recommended for ease of data capture) - ''see example'': [[Image:public comment form.jpg |1200px]]<br />
:* Select the document you are commenting on from the appropriate form<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Authoring Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19618Work Product for Review2024-01-19T16:56:02Z<p>Jlisiecki: /* Comment Submission */</p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* ** provide a link to a public comment form (Google forms are recommended for ease of data capture) - ''see example'': [[Image:public comment form.jpg |1200px]]<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Authoring Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19617Work Product for Review2024-01-19T16:55:19Z<p>Jlisiecki: /* Comment Submission */</p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* ** provide a link to a public comment form (Google forms are recommended for ease of data capture) - ''see example'': [[Image:public comment form.jpg |900px]]<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Authoring Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19616Work Product for Review2024-01-19T16:53:14Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* Visit the [https://forms.gle/qxPUJx7qbKSBaE9V6 QIBA Public Comment Form].<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Writing Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19615Work Product for Review2024-01-19T16:53:03Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* Visit the [https://forms.gle/qxPUJx7qbKSBaE9V6 QIBA Public Comment Form].<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Writing Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Review_Process&diff=19614Review Process2024-01-19T16:50:56Z<p>Jlisiecki: /* Review (Profile Authoring Group) */</p>
<hr />
<div>__NOTOC__<br />
Profiles are reviewed/approved by their parent Profile Authoring Group at [[QIBA Profile Stages|each Stage]]:<br />
* The review/approval steps are the same for each stage, but the '''[[QIBA Profile Stages|criteria differ]]''' <br />
* The '''[[Public Comment Process|Public Comment Review]]''' is another process that specifically covers soliciting and resolving comments that can come from beyond the Committee.<br />
<br />
<br />
Remember, this is the QA point for your work. It doesn't have to be perfect. '''It does have to be good'''.<br />
<br />
==Review (Profile Authoring Group)==<br />
The following review process is strongly recommended, but Profile Authoring Groups are not required to follow this specific process.<br />
* ''Editor'' of the Profile requests content review once they feel work on the current stage has been completed<br />
* ''Profile Authoring Group'' assigns/'''recruits reviewers''' for Profile sections<br />
** Ideally each section should be covered by more than one reviewer<br />
** Reviewing assignments can be divided up any way that is convenient<br />
** It is helpful to have some reviewers read through the profile in its entirety (finds inconsistencies/gaps)<br />
* ''Reviewers'' check the Profile meets the '''[[QIBA Profile Stages|criteria for the stage]]''' as well as '''[[How_to_Write_a_Profile#Follow_Profile_Writing_Guidelines|guidelines for clarity/quality]]''' <br />
** A two week window for the reviewers to do their work is suggested<br />
* ''Reviewers'' '''report back''' to the Profile Authoring Group<br />
* ''Authors and Profile Authoring Group'' resolve any questions/comments/clarifications raised by the reviewers<br />
* ''Co-chair'' accepts a motion to send the document to ballot<br />
<br />
==Approve (Profile Authoring Group)==<br />
The main purpose of '''Profile Authoring Group''' approval is to '''confirm that all the detailed contents are correct, and the Profile meets the criteria''' for the stage.<br />
<br />
* ''Profile Authoring Group'' submits the '''Profile document''' and, if approving for a stage after Public Comment, the '''[[QIBA Profile Stages|supporting document for that stage]]'''<br />
* ''Profile Authoring Group'' circulates a '''[[Committee_Procedures#Email_Ballot|Ballot]]''' asking Profile Authoring Group members to approve that the content of the '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
** The Profile document and supporting document are attached to or linked from the ballot<br />
** The ballot period should be 2-5 weeks (typically 30 days) to allow time to review the full Profile text<br />
** In the case of approving to publish for Public Comment, it is acceptable to instead hold a vote during a meeting.<br />
* ''Profile Authoring Group members'' review the profile and supporting document and confirm '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
* ''Profile Authoring Group'' reviews and ratifies the '''[[Committee_Procedures#Email_Ballot|Ballot]]''' results <br />
* ''Profile Authoring Group'' reviews any contentious ballot comment resolutions</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Review_Process&diff=19613Review Process2024-01-19T16:49:53Z<p>Jlisiecki: </p>
<hr />
<div>__NOTOC__<br />
Profiles are reviewed/approved by their parent Profile Authoring Group at [[QIBA Profile Stages|each Stage]]:<br />
* The review/approval steps are the same for each stage, but the '''[[QIBA Profile Stages|criteria differ]]''' <br />
* The '''[[Public Comment Process|Public Comment Review]]''' is another process that specifically covers soliciting and resolving comments that can come from beyond the Committee.<br />
<br />
<br />
Remember, this is the QA point for your work. It doesn't have to be perfect. '''It does have to be good'''.<br />
<br />
==Review (Profile Authoring Group)==<br />
The following review process is strongly recommended, but Biomarker Committees are not required to follow this specific process.<br />
* ''Editor'' of the Profile requests content review once they feel work on the current stage has been completed<br />
* ''Profile Authoring Group'' assigns/'''recruits reviewers''' for Profile sections<br />
** Ideally each section should be covered by more than one reviewer<br />
** Reviewing assignments can be divided up any way that is convenient<br />
** It is helpful to have some reviewers read through the profile in its entirety (finds inconsistencies/gaps)<br />
* ''Reviewers'' check the Profile meets the '''[[QIBA Profile Stages|criteria for the stage]]''' as well as '''[[How_to_Write_a_Profile#Follow_Profile_Writing_Guidelines|guidelines for clarity/quality]]''' <br />
** A two week window for the reviewers to do their work is suggested<br />
* ''Reviewers'' '''report back''' to the Profile Authoring Group<br />
* ''Authors and Profile Authoring Group'' resolve any questions/comments/clarifications raised by the reviewers<br />
* ''Co-chair'' accepts a motion to send the document to ballot<br />
<br />
==Approve (Profile Authoring Group)==<br />
The main purpose of '''Profile Authoring Group''' approval is to '''confirm that all the detailed contents are correct, and the Profile meets the criteria''' for the stage.<br />
<br />
* ''Profile Authoring Group'' submits the '''Profile document''' and, if approving for a stage after Public Comment, the '''[[QIBA Profile Stages|supporting document for that stage]]'''<br />
* ''Profile Authoring Group'' circulates a '''[[Committee_Procedures#Email_Ballot|Ballot]]''' asking Profile Authoring Group members to approve that the content of the '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
** The Profile document and supporting document are attached to or linked from the ballot<br />
** The ballot period should be 2-5 weeks (typically 30 days) to allow time to review the full Profile text<br />
** In the case of approving to publish for Public Comment, it is acceptable to instead hold a vote during a meeting.<br />
* ''Profile Authoring Group members'' review the profile and supporting document and confirm '''Profile meets the [[QIBA Profile Stages|criteria for the stage]]'''<br />
* ''Profile Authoring Group'' reviews and ratifies the '''[[Committee_Procedures#Email_Ballot|Ballot]]''' results <br />
* ''Profile Authoring Group'' reviews any contentious ballot comment resolutions</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19612Public Comment Process2024-01-19T16:40:11Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to a public comment form (Google forms are recommended for ease of data capture) - ''see example'': [[Image:public comment form.jpg |900px]]<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope)<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19611Public Comment Process2024-01-19T16:38:29Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to a public comment form (Google forms are recommended for ease of data capture) - see example: [[Image:public comment form.jpg |900px]]<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=File:Public_comment_form.jpg&diff=19610File:Public comment form.jpg2024-01-19T16:35:46Z<p>Jlisiecki: </p>
<hr />
<div></div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19609Public Comment Process2024-01-19T16:35:21Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to a public comment form (Google forms are recommended for ease of data capture) - see example: [[Image:public comment form.jpg |200px]]<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19608Public Comment Process2024-01-19T16:34:49Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to a public comment form (Google forms are recommended for ease of data capture) - see example: [[Image public comment form.jpg |200px]]<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19607Public Comment Process2024-01-19T16:22:52Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Profile Authoring Group'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to Profile Authoring Group<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''Profile Authoring Group'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to the '''[http://tinyurl.com/QIBA-Public-Comment-Form QIBA Public Comment Form]'''<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to Profile Authoring Group (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''Profile Authoring Group''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Profile Authoring Group'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''Profile Authoring Group'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Profile Authoring Group'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''Profile Authoring Group'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19606Public Comment Process2024-01-19T16:17:52Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<font color="red">NOTICE: These instructions are accessible on the QIBA Wiki as a historical reference only! Independent Profile Authoring Groups are required to oversee the various developmental stages from Draft to Public Comment to Consensus based on the current QUIC endorsement criteria, found HERE:</font> https://qibawiki.rsna.org/images/9/95/QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf.<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Biomarker Committee'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''RSNA Staff'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''RSNA Staff'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to the '''[http://tinyurl.com/QIBA-Public-Comment-Form QIBA Public Comment Form]'''<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to RSNA Staff (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''RSNA Staff''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Biomarker Committee'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''RSNA Staff'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Biomarker Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''RSNA Staff'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19605Work Product for Review2024-01-17T23:21:42Z<p>Jlisiecki: </p>
<hr />
<div>[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* Visit the [https://forms.gle/qxPUJx7qbKSBaE9V6 QIBA Public Comment Form].<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Writing Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Work_Product_for_Review&diff=19604Work Product for Review2024-01-17T23:01:53Z<p>Jlisiecki: /* Comment Submission */</p>
<hr />
<div>QIBA '''[[Profiles|Profile documents]]''' are posted for '''[[Public Comment Process|Public Comment]]''' to ensure stakeholder representation, transparency and quality review. Interested people are encouraged to provide input on the document, the scenarios and use cases they address, the technologies proposed and other details. <br />
<br />
==Comment Submission==<br />
<br />
* Visit the [https://forms.gle/qxPUJx7qbKSBaE9V6 QIBA Public Comment Form].<br />
:* Select the document you are commenting on from the dropdown menu<br />
:* Provide your name and email address<br />
:* Add the Profile section and line number (if applicable) to which your comment refers<br />
:* Describe the issue and your propose a resolution<br />
:* When you have entered each of your comments, you may submit the form<br />
* e-mail Profile Writing Group with ''general comments'' about the Profile/Protocol concept, structure, process, etc.<br />
<br />
The [[Committees|QIBA Biomarker Committees]] consider all comments submitted, and where appropriate, post responses.<br />
<br />
==Public Comment Documents==<br />
<br />
see http://qibawiki.rsna.org/index.php/Profiles<br />
<br />
<br />
*[[Document Archive]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Public_Comment_Process&diff=19603Public Comment Process2024-01-17T22:40:05Z<p>Jlisiecki: </p>
<hr />
<div>Public Comment is intended to allow both regular participants in QIBA Activities and also those who don't have the time to dedicate to regular participation a chance to contribute their thoughts on proposed specifications before they are formally released. It's also an excellent chance to engage relevant stakeholder individuals and organizations. Comments are accepted from all.<br />
<br />
NOTE: ''If you receive few or no public comments, that's a'' '''bad sign.''' Presuming we didn't hit perfection on the first try, it means we didn't convince people it was important enough to read in any great detail. That bodes poorly for our ability to convince people it is important enough to read and conform to. Good [[Stakeholder Contacts|outreach]] is a significant part of Public Comment. It's our first stage at marketing the Profile.<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<br />
'''Preparation''':<br />
<br />
* ''Biomarker Committee'' follows the '''[[Review Process]]''' to review and approve the draft for Public Comment publication<br />
* ''Editor'' tidies up PC draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''RSNA Staff'' '''[[Publication Process|publishes PC draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Public Comment Stage]]. Work toward [[QIBA Profile Stages|Consensus]] begins.<br />
<br />
<br />
Period: 60 - 90 days (may be extended at the discretion of the committee)<br />
<br />
* ''RSNA Staff'' sends Public Comment announcement to mailing lists<br />
** explain the location of document to be reviewed, deadline for comment submission, method of submission<br />
** provide a link to the '''[http://tinyurl.com/QIBA-Public-Comment-Form QIBA Public Comment Form]'''<br />
** reach out to any '''[[Stakeholder Contacts|organizations and individuals]]''' that might have an interest or expertise to contribute<br />
* ''Commenters'' submit comments to RSNA Staff (via web form or emailed comment form)<br />
** commenters include committee members, other QIBA people, external bodies<br />
** this is the key point for asynchronous engagement<br />
** please use the comment forms; it saves the Editor having to transcribe your comments<br />
<br />
* When the public comment period expires<br />
** ''RSNA Staff''<br />
*** updates the bullet for this profile on the [[Profiles]] page to note when comments closed<br />
*** adds a row on the [[Comment Resolutions]] page for the profile (link to the PC doc in the first cell) <br />
<br />
<br />
'''Resolution''':<br />
<br />
* ''Editor'' collates all comments into a '''resolution spreadsheet''' (see '''[https://docs.google.com/spreadsheets/d/1o3_ssHHIABGKNesUJ_-jL5RYqSx9Eq4o6C2dlIsHQo4/edit?usp=sharing Google Sheet template]''' or '''[[:Media:QIBA_Public_Comment_Template-2011.01.doc | Word table]]'''<br />
** sort by line number and priority (Low/Med/High)<br />
** re-title the leftmost column from "Leave Blank" to "#"<br />
** fill the leftmost column with incrementing numbers. Now you can refer to "Comment #43", or re-sort the table if you like<br />
** re-title the rightmost column from "Leave Blank" to "Resolution"<br />
* ''Editor'' resolves comments with priority Low<br />
** turn on Change Tracking in Word<br />
** for most Low comments (typos), fix it in the Profile document and enter "Done" in the Resolution column of the resolution table<br />
** if any Low comments prove problematic, elevate to Med<br />
* ''Biomarker Committee'' reviews Med & High comments<br />
** step through the resolution table<br />
** each comment may be:<br />
*** accepted = proposed text accepted as is<br />
*** rejected = committee does not agree with issue (document reason, e.g. out of scope, )<br />
*** resolved = issue accepted but resolved differently than proposed<br />
** consider getting a 3-person sub-committee to take a '''first pass''' at this and focus the full committee on items needing discussion<br />
*** discussion attempts to achieve [[Committee_Procedures#Consensus_Process| consensus]] on the resolutions whenever possible<br />
*** eventually, if consensus is not forthcoming, the minority opinion may accede or put the issue to a vote. <br />
** The Google template includes a status column with codewords (Done, TODO, etc) to track progress resolving comments.<br />
* ''Editor'' records decision and explanation (as needed) in the Resolution column of the resolution table/spreadsheet<br />
** When a comment is not accepted, it is particularly important to include a good description of the rationale in the Resolution column as part of meeting our obligation to transparency and avoiding conflicts of interest.<br />
** Consider having assigned reviewers that cross-check the resolution table against the updated Profile document to confirm everything go in correctly<br />
*** Likely split this task up, giving a chunk of resolutions to each reviewer.<br />
<br />
<br />
* ''RSNA Staff'' posts resolution spreadsheet and change-tracked Profile Document on the Wiki<br />
** This helps people review the resolution of their comments and the changes that resulted from the Public Comment process<br />
* ''Biomarker Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Modality Coordination Committee'' [[Review Process|reviews and approves as Consensus]]<br />
* ''Editor'' tidies up Consensus draft (e.g. "accept all changes" in Word) and submits to RSNA Staff<br />
* ''RSNA Staff'' '''[[Publication Process|publishes Consensus draft]]'''<br />
* The Profile has now reached the [[QIBA Profile Stages|Consensus Stage]].</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=File:QIBA_Summary_Abridged_Version_21Dec2023-B.pdf&diff=19602File:QIBA Summary Abridged Version 21Dec2023-B.pdf2024-01-17T22:15:00Z<p>Jlisiecki: </p>
<hr />
<div></div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Main_Page&diff=19601Main Page2024-01-17T22:14:37Z<p>Jlisiecki: /* QIBA NEWS */</p>
<hr />
<div>__NOTOC__<br />
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=<br />
<br />
'''QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.'''<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<br />
:* [[Profiles|'''QIBA Profiles''']] standardize methods to create biomarkers that meet a claimed performance (accurate and reproducible).<br />
:* QIBA advances quantitative imaging in clinical trials and clinical practice.<br />
:* QIBA engages researchers, healthcare professionals and industry. <br />
:* '''[[QIBA Concepts]]''' & '''[[QIBA Overview]]''' & '''[[QIBA Collaborations]]'''<br />
:* '''[[Stakeholder Viewpoints|Stakeholder Benefits]]'''<br />
<br />
<br />
The navigation box to the left provides access to:<br />
* '''[[Profiles]]''' - biomarker specifications published by QIBA<br />
* '''[[Committees]]''' - developing biomarker Profiles and related work<br />
* '''[[Process]]es''' - guidance used by all Committees for developing Profiles and other QIBA work<br />
* '''[[QIBA Profile Conformance | Conformance]]''' - Self Attestation and Certification Services<br />
* '''[[QIBA News]]''' - Recent biomarker committee accomplishments, volunteer news items to share<br />
* '''[[Education]]''' - Introduction to QIBA, ''QIBA Newsletter'' archive, QIBA posters and presentations, and citations<br />
* '''[[Catalog|Resource Catalog]]''' - used for QIBA groundwork<br />
* '''[[About QIBA|About QIBA]]''' - an at-a-glance introduction and QIBA YouTube Playlist <br />
* '''[[QIBA Acknowledgments]]''' - Thank you to our volunteers!<br />
<br />
<br />
<br />
<br />
<br />
==<font color=blue>'''QIBA NEWS'''<font>==<br />
<br />
'''<br />
<font color="black">QIBA is Transitioning to QUIC!<br />
<br />
'''<br />
<br />
<font color="black">Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles.<br />
Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally. The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations.<br />
Answers to the FAQ submitted by QIBA members are provided below. <br />
<br />
*[[Media:12.23.2023 QIBA_Accomplishments_TJH-2.PDF|QIBA Accomplishments Slides (Dr. Timothy J. Hall, PhD)]]<br />
*[[Media:09.07.2023 LINK to FAQ PDF document2.PDF|FAQ PDF document]]<br />
*[[Media:QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf |QUIC Profile Endorsement Criteria]]<br />
*[[Media:QIBA Summary Abridged Version 21Dec2023-B.pdf |QIBA Summary – Abridged Version 21Dec2023]]<br />
<br />
<font color="black">The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket <br />
Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education. <br />
<br />
<br />
<font color="black">QIBA Videos are now posted to RSNA's YouTube Channel! https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.<br />
:[[Image:QIBA-YouTube-image.png|300px]]<br />
<br />
<br />
<br />
<font color="black">This wiki site is used primarily by the QIBA Committees. For the more formal QIBA website, [http://www.rsna.org/qiba/ Click Here].<br />
----<br />
'''''Quantitative Imaging is a Work in Progress: read the [[Stakeholder Viewpoints|Stakeholder Benefits]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=File:QIBA_Summary_Abridged_Version_21Dec2023-2.pdf&diff=19600File:QIBA Summary Abridged Version 21Dec2023-2.pdf2024-01-17T22:07:24Z<p>Jlisiecki: </p>
<hr />
<div></div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=Main_Page&diff=19599Main Page2024-01-17T22:06:25Z<p>Jlisiecki: /* QIBA NEWS */</p>
<hr />
<div>__NOTOC__<br />
='''Quantitative Imaging Biomarkers Alliance (QIBA)'''=<br />
<br />
'''QIBA Mission: Improve the value and practicality of quantitative imaging biomarkers by reducing variability across devices, sites, patients, and time.'''<br />
<br />
[[Image:QIBA_WIKI_BLURB.jpg|600px]]<br />
<br />
<br />
:* [[Profiles|'''QIBA Profiles''']] standardize methods to create biomarkers that meet a claimed performance (accurate and reproducible).<br />
:* QIBA advances quantitative imaging in clinical trials and clinical practice.<br />
:* QIBA engages researchers, healthcare professionals and industry. <br />
:* '''[[QIBA Concepts]]''' & '''[[QIBA Overview]]''' & '''[[QIBA Collaborations]]'''<br />
:* '''[[Stakeholder Viewpoints|Stakeholder Benefits]]'''<br />
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The navigation box to the left provides access to:<br />
* '''[[Profiles]]''' - biomarker specifications published by QIBA<br />
* '''[[Committees]]''' - developing biomarker Profiles and related work<br />
* '''[[Process]]es''' - guidance used by all Committees for developing Profiles and other QIBA work<br />
* '''[[QIBA Profile Conformance | Conformance]]''' - Self Attestation and Certification Services<br />
* '''[[QIBA News]]''' - Recent biomarker committee accomplishments, volunteer news items to share<br />
* '''[[Education]]''' - Introduction to QIBA, ''QIBA Newsletter'' archive, QIBA posters and presentations, and citations<br />
* '''[[Catalog|Resource Catalog]]''' - used for QIBA groundwork<br />
* '''[[About QIBA|About QIBA]]''' - an at-a-glance introduction and QIBA YouTube Playlist <br />
* '''[[QIBA Acknowledgments]]''' - Thank you to our volunteers!<br />
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==<font color=blue>'''QIBA NEWS'''<font>==<br />
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<font color="black">QIBA is Transitioning to QUIC!<br />
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<font color="black">Over the past 16 years, RSNA QIBA has become recognized as a community of representatives of healthcare professionals, medical associations, government regulatory agencies, pharmaceutical and scanner industries, conducting numerous groundwork studies, working on metrology underpinnings, and developing consensus among experts in the field to create rigorous quantitative imaging Profiles.<br />
Since its creation, QIBA’s work has developed and demonstrated the value and practicality of quantitative imaging biomarkers, nationally and internationally. The next stage in this evolution is to expand RSNA’s quantitative imaging activities beyond development of Profiles, to work with stakeholders to focus on adoption and implementation in clinical trials and practice. The RSNA Board of Directors has created a Quantitative Imaging Committee (QUIC) to oversee this initiative. The QUIC will be comprised of radiologists, physicists, and other thought leaders from stakeholder groups, including industry, government, and partner organizations.<br />
Answers to the FAQ submitted by QIBA members are provided below. <br />
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*[[Media:12.23.2023 QIBA_Accomplishments_TJH-2.PDF|QIBA Accomplishments Slides (Dr. Timothy J. Hall, PhD)]]<br />
*[[Media:09.07.2023 LINK to FAQ PDF document2.PDF|FAQ PDF document]]<br />
*[[Media:QUIC-Review-Criteria-for-New-Profiles-FINAL-v23SEPT2023.pdf |QUIC Profile Endorsement Criteria]]<br />
*[[Media:QIBA Summary Abridged Version 21Dec2023-2.pdf |QIBA Summary – Abridged Version 21Dec2023]]<br />
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<font color="black">The Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket <br />
Submissions Guidance for Industry and Food and Drug Administration (FDA) Staff was released on June 16, 2022, and can be accessed via the QIBA Education page: https://qibawiki.rsna.org/index.php/Education. <br />
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<font color="black">QIBA Videos are now posted to RSNA's YouTube Channel! https://tinyurl.com/QIBA-YouTube-Playlist. These videos have been created by our QIBA volunteers. Learn more about RSNA’s Quantitative Imaging Biomarkers Alliance® (QIBA), which unites researchers, health care professionals and industry to advance quantitative imaging and the use of imaging biomarkers in clinical trials and clinical practice. Please note: All QIBA promotional materials need to be reviewed and approved by RSNA.<br />
:[[Image:QIBA-YouTube-image.png|300px]]<br />
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<font color="black">This wiki site is used primarily by the QIBA Committees. For the more formal QIBA website, [http://www.rsna.org/qiba/ Click Here].<br />
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'''''Quantitative Imaging is a Work in Progress: read the [[Stakeholder Viewpoints|Stakeholder Benefits]]</div>Jlisieckihttps://qibawiki.rsna.org/index.php?title=File:2023_12-18_QIBA_PET_MBF_Biomarker_Ctte_Call_Summary_FINAL.pdf&diff=19598File:2023 12-18 QIBA PET MBF Biomarker Ctte Call Summary FINAL.pdf2024-01-17T21:42:28Z<p>Jlisiecki: </p>
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<div></div>Jlisiecki