Difference between revisions of "Process"
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| Line 26: | Line 26: | ||
:** [[QIBA Profile Template]] and [[Claim Guidance]] | :** [[QIBA Profile Template]] and [[Claim Guidance]] | ||
:* [[Groundwork Process|Initiate/Conduct Groundwork]] | :* [[Groundwork Process|Initiate/Conduct Groundwork]] | ||
| − | :* [[Review Process|Review & Approve]] | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft |
:** [[Work Product for Review]] | :** [[Work Product for Review]] | ||
| Line 32: | Line 32: | ||
:* [[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]] | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile |
'''Technical Confirmation Stage''' | '''Technical Confirmation Stage''' | ||
| Line 38: | Line 38: | ||
:** [[QIBA Protocol/Profile Implementation Feedback Process]] | :** [[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]] | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile |
'''Claim Confirmation Stage''' | '''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]] | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile |
'''Clinical Confirmation Stage''' | '''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]] | + | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile |
'''Profile Maintenance''' | '''Profile Maintenance''' | ||
Revision as of 02:10, 4 January 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.
Procedures and Conventions
QIBA Profiling Process
QIBA Profile Stages & QIBA Concepts
Selection
Drafting and Public Comment Stage
- Draft QIBA Profile
- Initiate/Conduct Groundwork
- Review & Approve then Publish Public Comment Draft
Consensus Stage (Publicly Reviewed)
- Collect & Collate Public Comments
- Reach Consensus on resolution for all comments
- Review & Approve then Publish Consensus Profile
Technical Confirmation Stage
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Technically Confirmed Profile
Claim Confirmation Stage
- Plan & Coordinate Claim Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Claim Confirmed Profile
Clinical Confirmation Stage
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Clinically Confirmed Profile
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 Write a Profile
- Profile Editions
- Change Tracking and File Naming
- Wiki Page Templates
- How To's for this Wiki
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA