Difference between revisions of "Process"
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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. | 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. | + | The details of how those steps are carried out is described here. The [[Process Coordinating Committee]] manages this content. Comments are welcome. |
==Committee Procedures== | ==Committee Procedures== | ||
| Line 11: | Line 13: | ||
** [[Committee Sunset Process]] | ** [[Committee Sunset Process]] | ||
* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] | * [[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== | ==Profile Creation== | ||
| Line 21: | Line 24: | ||
:* [[Expressing Requirements]] | :* [[Expressing Requirements]] | ||
:* [[Assessment Procedure Guidance]] | :* [[Assessment Procedure Guidance]] | ||
| + | :* [[Profile Editions]] | ||
* [[Review Process]] | * [[Review Process]] | ||
* [[Public Comment Process]] | * [[Public Comment Process]] | ||
| Line 35: | Line 39: | ||
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] | :** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] | ||
:* [[Groundwork Process|Initiate/Conduct Groundwork]] | :* [[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 | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | ||
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | :* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | ||
| Line 44: | Line 49: | ||
:* You have reached Stage 2 | :* You have reached Stage 2 | ||
| − | ====Getting to Stage 3: Technically Confirmed==== | + | ====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)==== |
:* Recruit Sites to Field Test the Profile | :* Recruit Sites to Field Test the Profile | ||
| − | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation | + | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]] |
| − | |||
:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile | :* [[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 | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile |
:* You have reached Stage 3 | :* You have reached Stage 3 | ||
| Line 58: | Line 62: | ||
:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | :* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | ||
:* You have reached Stage 4 | :* You have reached Stage 4 | ||
| − | |||
| − | |||
| − | |||
| − | |||
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====Profile Maintenance==== | ====Profile Maintenance==== | ||
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* [[Groundwork Process]] | * [[Groundwork Process]] | ||
| − | ** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]] | + | **[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]] |
* Funding Submission Process | * Funding Submission Process | ||
* Evaluation and Selection Process | * Evaluation and Selection Process | ||
| − | ** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]] | + | **[[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 | * 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 | ||
Latest revision as of 19:32, 19 January 2024
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.
Committee Procedures
- Committee Procedures
- Committee Organization
- QIBA Patent Disclosure Policy
- QIBA Conflict of Interest (COI) Policy
Profile Creation
Guidance
Process Steps
Understand QIBA Profile Stages & QIBA Concepts
Getting to Stage 1: Public Comment
- Submit Proposals
- 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
- Initiate/Conduct Groundwork
- Vet your Requirements before publishing for Public Comment
- Review & Approve then Publish Public Comment Draft
- You have reached Stage 1
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: Clinically Feasible (formerly Technically Confirmed)
- Recruit Sites to Field Test the Profile
- Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation
- Collect and Resolve Feedback from sites based on their experience using the profile
- Review & Approve then Publish Clinically Feasible (formerly 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
Profile Maintenance
Profile Retirement
Groundwork Projects and Funding
Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.
- Groundwork Process
- Funding Submission Process
- Evaluation and Selection Process
- 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
See Also
- How To's for this Wiki
- Wiki Page Templates
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA