Difference between revisions of "Process"

Revision as of 22:48, 18 January 2022

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.

The details of how those steps are carried out is described here. The Process Coordinating Committee manages this content. Comments are welcome. Email QIBA

Committee Procedures

Profile Creation

Getting to Stage 2: Consensus

Collect & Collate Public Comments
Reach Consensus on resolution for all comments
Review & Approve then Publish Consensus Profile
You have reached Stage 2

Getting to Stage 3: Technically Confirmed

Recruit Sites to Field Test the Profile
Plan & Coordinate Technical Confirmation
- See QIBA Protocol/Profile Implementation Feedback Process
Collect and Resolve Feedback from sites based on their experience using the profile
Review & Approve then Publish Technically Confirmed Profile
You have reached Stage 3

Getting to Stage 4: Claim Confirmed

4a. Design Method to assess site performance (in terms of metrics in Profile Claims, e.g., wCV)
4b. Recruit sites to follow the Profile and assess site performance per 4a
4c. Analyze Site Performance Data and assess against Profile Claim
4d. Review & Approve then Publish Claim Confirmed Profile
You have reached Stage 4

Getting to Stage 5: Clinically Confirmed

Plan & Coordinate Clinical Confirmation
Collect and Resolve Feedback
Review & Approve then Publish Clinically Confirmed Profile
You have reached Stage 5

Profile Maintenance

Profile Retirement

Review for Retirement

Groundwork Projects and Funding

Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.

Groundwork Process
- Imaging Biomarker Roadmap for QIBA Profiles
Funding Submission Process
Evaluation and Selection Process
- Proposed Categories for QIBA Project Proposal Submissions
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

Conformance

Profile Conformance

QIBA Conformance Statement Template

QIBA Profile Conformance

@@ Line 1: / Line 1: @@
-__NOTOC__
+{{TOCright}}
-QIBA is still evolving its processes but the following pages present current thoughts.
+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.
-Much of this is adapted from DICOM and IHE processes.
+The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content.  Comments are welcome. [mailto:qiba@rsna.org Email QIBA]
-==Overview==
+==Committee Procedures==
-* [[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
-==Procedures and Conventions==
+* [[Committee Procedures]]
+** [[Voting Privileges]]
+* [[Committee Organization]]
+** [[Committee Sunset Process]]
+* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
+* [[Media:QIBA Conflict of Interest (COI) Policy-2021.10.28.pdf|QIBA Conflict of Interest (COI) Policy]]
+==Profile Creation==
+===Guidance===
+* '''[[How to Write a Profile]]'''
 :* [[QIBA Profile Template]]
-:* [[Change Tracking]]
+:* [[Claim Guidance]]
-:* [[File Naming]]
+:* [[Vetting Requirements]]
+:* [[Expressing Requirements]]
+:* [[Assessment Procedure Guidance]]
+* [[Review Process]]
+* [[Public Comment Process]]
+* [[Publication Process]]
+===Process Steps===
+Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
+====Getting to Stage 1: Public Comment====
+:* [[Selection Process|Submit Proposals]]
+:* [[Selection Process|Evaluate and Approve Proposals]]
+:* Start Drafting the Profile
+:** See '''[[How to Write a Profile]]''' including specific editing guidelines
+:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
+:* [[Groundwork Process|Initiate/Conduct Groundwork]]
+:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
+:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
-:* QIBA Profile Template (2011)
+====Getting to Stage 2: Consensus====
-::* An updated version of the template will be published in late 2012 based on revisions to address feedback from the first round of profile development.
+:* [[Public Comment Process|Collect & Collate Public Comments]]
-::* [https://docs.google.com/spreadsheet/ccc?key=0AkfpWndrzLS2dHg2UmlHd042QURhTndBY2I4RG1EdFE QIBA Profile Template Improvements 2012]
+:* Reach Consensus on resolution for all comments
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
+:* You have reached Stage 2
-[[:Category:Templates|Wiki Page Templates]]
+====Getting to Stage 3: Technically Confirmed====
+:* Recruit Sites to Field Test the Profile
+:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
+:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
+:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
+:* You have reached Stage 3
-* [[Committee Procedures]]
+====Getting to Stage 4: Claim Confirmed====
-* [[Publication Process]]
+:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)
-* [[Balloting Process]]
+:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
+:* 4c. Analyze Site Performance Data and assess against Profile Claim
+:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
+:* You have reached Stage 4
-==QIBA Profiling Stages==
+====Getting to Stage 5: Clinically Confirmed====
-* Selection
+:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
-** [[Selection Process|Submit Proposals]]
+:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
-** [[Selection Process|Evaluate and Approve Proposals]]
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
+:* You have reached Stage 5
-* Drafting
+====Profile Maintenance====
-** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
+:* [[Maintenance Process|Accept and Resolve Change Proposals]]
-** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
+:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
-** [[Groundwork Process|Initiate/Conduct Groundwork]]
-** [[Review Process|Approve & Publish Public Comment Draft]]
-* Review
+====Profile Retirement====
-** [[Public Comment Process|Collect and Resolve Public Comment]]
+:* [[Retirement Process|Review for Retirement]]
-** [[Review Process|Approve & Publish Reviewed Draft]]
-* Technical Confirmation
+==Groundwork Projects and Funding==
-** [[Confirmation Process|Distribute for Technical Confirmation]]
+[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
-** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
-** [[Review Process|Approve & Publish Technically Confirmed Draft]]
-* Clinical Confirmation
+* [[Groundwork Process]]
-** [[Confirmation Process|Distribute for Clinical Confirmation]]
+** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
-** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+* Funding Submission Process
-** [[Review Process|Approve & Publish Clinically Confirmed Draft]]
+* Evaluation and Selection Process
+** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
+* 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
-* Maintenance
+==Conformance==
-** [[Maintenance Process|Accept and Resolve Change Proposals]]
+* [[Profile Conformance]]
-** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
+:* [[QIBA Conformance Statement Template]]
+* [[QIBA Profile Conformance]]
-* Retirement
+==See Also==
-** [[Retirement Process|Review for Retirement]]
+* '''[[How To's]]''' for this Wiki
+* [[:Category:Templates|Wiki Page Templates]]
+* [[Profile Editions]]
+* [[Change Tracking and File Naming]]
+* [[Clinical Trial Planning]]
-==See Also==
+* [[Orphan Documents]]
 * [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

Difference between revisions of "Process"

Revision as of 22:48, 18 January 2022

Contents

Committee Procedures

Profile Creation

Guidance

Process Steps

Getting to Stage 1: Public Comment