Difference between revisions of "Process"
Jump to navigation
Jump to search
(Drop Stage 5 references) |
|||
Line 22: | Line 22: | ||
:* [[Expressing Requirements]] | :* [[Expressing Requirements]] | ||
:* [[Assessment Procedure Guidance]] | :* [[Assessment Procedure Guidance]] | ||
+ | :* [[Profile Editions]] | ||
* [[Review Process]] | * [[Review Process]] | ||
* [[Public Comment Process]] | * [[Public Comment Process]] |
Revision as of 19:21, 8 November 2022
QIBA industrializes biomarkers by selecting biomarkers ready for industrialization, investigating underlying sources of variance and 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. Comments are welcome. Email QIBA
Committee Procedures
- Committee Procedures
- Committee Organization
- QIBA Patent Disclosure Policy
- QIBA Conflict of Interest (COI) Policy
Profile Creation
Guidance
Process Steps
Understand QIBA Profile Stages & QIBA Concepts
Getting to Stage 1: Public Comment
- Submit Proposals
- Evaluate and Approve Proposals
- Start Drafting the Profile
- See How to Write a Profile including specific editing guidelines
- See QIBA Profile Template and Claim Guidance and Assessment Procedure Guidance
- Initiate/Conduct Groundwork
- Vet your Requirements before publishing for Public Comment
- Review & Approve then Publish Public Comment Draft
- You have reached Stage 1
Getting to Stage 2: Consensus
- Collect & Collate Public Comments
- Reach Consensus on resolution for all comments
- Review & Approve then Publish Consensus Profile
- You have reached Stage 2
Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)
- Recruit Sites to Field Test the Profile
- Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation
- Collect and Resolve Feedback from sites based on their experience using the profile
- Review & Approve then Publish Clinically Feasible (formerly Technically Confirmed) Profile
- You have reached Stage 3
Getting to Stage 4: Claim Confirmed
- 4a. Design Method to assess site performance (in terms of metrics in Profile Claims, e.g., wCV)
- 4b. Recruit sites to follow the Profile and assess site performance per 4a
- 4c. Analyze Site Performance Data and assess against Profile Claim
- 4d. Review & Approve then Publish Claim Confirmed Profile
- You have reached Stage 4
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's for this Wiki
- Wiki Page Templates
- Orphan Documents
- Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA