Difference between revisions of "Process"
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| Line 20: | Line 20: | ||
:* [[Selection Process|Evaluate and Approve Proposals]] | :* [[Selection Process|Evaluate and Approve Proposals]] | ||
| − | '''Drafting and Public Comment Stage''' | + | '''Stage 1: Drafting and Public Comment Stage''' |
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]] | :* [[QIBA Profile Drafting Process|Draft QIBA Profile]] | ||
:** See [[How to Write a Profile]] | :** See [[How to Write a Profile]] | ||
| Line 27: | Line 27: | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | ||
:** See [[Work Product for Review]] | :** See [[Work Product for Review]] | ||
| + | :* You have completed Stage 1 | ||
| − | '''Consensus Stage (Publicly Reviewed)''' | + | '''Stage 2: Consensus Stage (Publicly Reviewed)''' |
:* [[Public Comment Process|Collect & Collate Public Comments]] | :* [[Public Comment Process|Collect & Collate Public Comments]] | ||
:* Reach Consensus on resolution for all comments | :* Reach Consensus on resolution for all comments | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | ||
| + | :* You have completed Stage 2 | ||
| − | '''Technical Confirmation Stage''' | + | '''Stage 3: Technical Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | ||
:** See [[QIBA Protocol/Profile Implementation Feedback Process]] | :** See [[QIBA Protocol/Profile Implementation Feedback Process]] | ||
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | ||
| + | :* You have completed Stage 3 | ||
| − | '''Claim Confirmation Stage''' | + | '''Stage 4: Claim Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | ||
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | ||
| + | :* You have completed Stage 4 | ||
| − | '''Clinical Confirmation Stage''' | + | '''Stage 5: Clinical Confirmation Stage''' |
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] | ||
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | ||
| + | :* You have completed Stage 5 | ||
'''Profile Maintenance''' | '''Profile Maintenance''' | ||
Revision as of 00:55, 18 February 2017
Overview
QIBA attempts to industrialize biomarkers by selecting biomarkers ready for industrialization, investigating underlying sources of variance and other 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.
Committee Procedures
Profiling Process
Understand QIBA Profile Stages & QIBA Concepts
Selection
Stage 1: Drafting and Public Comment Stage
- Draft QIBA Profile
- Initiate/Conduct Groundwork
- Review & Approve then Publish Public Comment Draft
- You have completed Stage 1
Stage 2: Consensus Stage (Publicly Reviewed)
- Collect & Collate Public Comments
- Reach Consensus on resolution for all comments
- Review & Approve then Publish Consensus Profile
- You have completed Stage 2
Stage 3: Technical Confirmation Stage
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Technically Confirmed Profile
- You have completed Stage 3
Stage 4: Claim Confirmation Stage
- Plan & Coordinate Claim Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Claim Confirmed Profile
- You have completed Stage 4
Stage 5: Clinical Confirmation Stage
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Clinically Confirmed Profile
- You have completed Stage 5
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
- Profile Editions
- Change Tracking and File Naming
- Wiki Page Templates
- How To's for this Wiki
- Public Comment Process
- Review Process
- Publication Process
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA