Difference between revisions of "Process"
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:* [[Selection Process|Evaluate and Approve Proposals]] | :* [[Selection Process|Evaluate and Approve Proposals]] | ||
:** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]] | :** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]] | ||
| + | |||
'''Drafting and Public Comment Stage''' | '''Drafting and Public Comment Stage''' | ||
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]] | :* [[QIBA Profile Drafting Process|Draft QIBA Profile]] | ||
:** [[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 Public Comment Draft]] | + | :* [[Review Process|Review & Approve]] Public Comment Draft then [[Publication Process|Publish]] |
| + | :** [[Work Product for Review]] | ||
| + | |||
'''Consensus Stage (Publicly Reviewed)''' | '''Consensus Stage (Publicly Reviewed)''' | ||
:* [[Public Comment Process|Collect & Collate Comments]] | :* [[Public Comment Process|Collect & Collate Comments]] | ||
| − | |||
:* Reach Consensus on resolution for all comments | :* Reach Consensus on resolution for all comments | ||
| − | :* [[Review Process|Review & Approve Consensus Profile | + | :* [[Review Process|Review & Approve]] Consensus Profile then [[Publication Process|Publish]] |
| − | + | ||
'''Technical Confirmation Stage''' | '''Technical Confirmation Stage''' | ||
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | :* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | ||
:** [[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 Technically Confirmed Profile | + | :* [[Review Process|Review & Approve]] Technically Confirmed Profile then [[Publication Process|Publish]] |
| − | + | ||
'''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 Claim Confirmed Profile | + | :* [[Review Process|Review & Approve]] Claim Confirmed Profile then [[Publication Process|Publish]] |
| − | + | ||
'''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 Clinically Confirmed Profile | + | :* [[Review Process|Review & Approve]] Clinically Confirmed Profile then [[Publication Process|Publish]] |
| − | + | ||
'''Profile Maintenance''' | '''Profile Maintenance''' | ||
:* [[Maintenance Process|Accept and Resolve Change Proposals]] | :* [[Maintenance Process|Accept and Resolve Change Proposals]] | ||
:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]] | :* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]] | ||
| + | |||
'''Profile Retirement''' | '''Profile Retirement''' | ||
:* [[Retirement Process|Review for Retirement]] | :* [[Retirement Process|Review for Retirement]] | ||
Revision as of 01:12, 15 November 2016
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
Selection
Drafting and Public Comment Stage
- Draft QIBA Profile
- Initiate/Conduct Groundwork
- Review & Approve Public Comment Draft then Publish
Consensus Stage (Publicly Reviewed)
- Collect & Collate Comments
- Reach Consensus on resolution for all comments
- Review & Approve Consensus Profile then Publish
Technical Confirmation Stage
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback
- Review & Approve Technically Confirmed Profile then Publish
Claim Confirmation Stage
- Plan & Coordinate Claim Confirmation
- Collect and Resolve Feedback
- Review & Approve Claim Confirmed Profile then Publish
Clinical Confirmation Stage
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve Clinically Confirmed Profile then Publish
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
See Also
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA
- Orphan Documents
- How to Write a Profile