Process
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
Drafting and Public Comment Stage
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
- 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