Difference between revisions of "Process"
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[[QIBA Profile Stages]] | [[QIBA Profile Stages]] | ||
| − | + | '''Selection''' | |
| − | + | :* [[Selection Process|Submit Proposals]] | |
| − | + | :* [[Selection Process|Evaluate and Approve Proposals]] | |
| − | + | :** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]] | |
| − | + | '''Drafting and Public Comment Stage''' | |
| − | + | :* [[QIBA Profile Drafting Process|Draft QIBA Profile]] | |
| − | + | :** [[QIBA Profile Template]] and [[Claim Guidance]] | |
| − | + | :* [[Groundwork Process|Initiate/Conduct Groundwork]] | |
| − | + | :* [[Review Process|Review & Approve Public Comment Draft]] | |
| − | + | '''Consensus Stage (Publicly Reviewed)''' | |
| − | + | :* [[Public Comment Process|Collect & Collate Comments]] | |
| − | + | :** [[Work Product for Review]] | |
| − | + | :* Reach Consensus on resolution for all comments | |
| − | + | :* [[Review Process|Review & Approve Consensus Profile]] | |
| − | + | :* [[Publication Process|Publish Consensus Profile]] | |
| − | + | '''Technical Confirmation Stage''' | |
| − | + | :* [[Confirmation Process|Plan & Coordinate Technical Confirmation]] | |
| − | + | :** [[QIBA Protocol/Profile Implementation Feedback Process]] | |
| − | + | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | |
| − | + | :* [[Review Process|Review & Approve Technically Confirmed Profile]] | |
| − | + | :* [[Publication Process|Publish Technically Confirmed Profile]] | |
| − | + | '''Claim Confirmation Stage''' | |
| − | + | :* [[Confirmation Process|Plan & Coordinate Claim Confirmation]] | |
| − | + | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | |
| − | + | :* [[Review Process|Review & Approve Claim Confirmed Profile]] | |
| − | + | :* [[Publication Process|Publish Claim Confirmed Profile]] | |
| − | + | '''Clinical Confirmation Stage''' | |
| − | + | :* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]] | |
| − | + | :* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]] | |
| − | + | :* [[Review Process|Review & Approve Clinically Confirmed Profile]] | |
| − | + | :* [[Publication Process|Publish Clinically Confirmed Profile]] | |
| − | + | '''Profile Maintenance''' | |
| − | + | :* [[Maintenance Process|Accept and Resolve Change Proposals]] | |
| − | + | :* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]] | |
| − | + | '''Profile Retirement''' | |
| − | + | :* [[Retirement Process|Review for Retirement]] | |
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==Groundwork Projects and Funding== | ==Groundwork Projects and Funding== | ||
Revision as of 00:57, 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
Consensus Stage (Publicly Reviewed)
- Collect & Collate Comments
- Reach Consensus on resolution for all comments
- Review & Approve Consensus Profile
- Publish Consensus Profile
Technical Confirmation Stage
Claim Confirmation Stage
Clinical Confirmation Stage
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