Difference between revisions of "Process"
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| Line 26: | Line 26: | ||
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]] | Understand [[QIBA Profile Stages]] & [[QIBA Concepts]] | ||
| − | + | ====Getting to Stage 1: Public Comment==== | |
:* [[Selection Process|Submit Proposals]] | :* [[Selection Process|Submit Proposals]] | ||
:* [[Selection Process|Evaluate and Approve Proposals]] | :* [[Selection Process|Evaluate and Approve Proposals]] | ||
| Line 37: | Line 37: | ||
| − | + | ====Getting to Stage 2: Consensus==== | |
:* [[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 | ||
| Line 44: | Line 44: | ||
| − | + | ====Getting to Stage 3: Technically Confirmed==== | |
:* Recruit Sites to Field Test the Profile | :* Recruit Sites to Field Test the Profile | ||
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]] | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]] | ||
| Line 53: | Line 53: | ||
| − | + | ====Getting to Stage 4: Claim Confirmed==== | |
:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV) | :* 4a. [[Claim Confirmation_Process#Planning|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 | :* 4b. Recruit sites to follow the Profile and assess site performance per 4a | ||
| Line 61: | Line 61: | ||
| − | + | ====Getting to Stage 5: Clinically Confirmed==== | |
:* [[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]] | ||
| Line 68: | Line 68: | ||
| − | + | ====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==== | |
:* [[Retirement Process|Review for Retirement]] | :* [[Retirement Process|Review for Retirement]] | ||
Revision as of 21:17, 2 February 2021
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
Profile Creation
Guidance
- How to Write a Profile
- QIBA Profile Template
- Claim Guidance
- Assessment Procedure Guidance
- Review Process
- Public Comment Process
- Publication Process
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
- 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: Technically Confirmed
- Recruit Sites to Field Test the Profile
- Plan & Coordinate Technical Confirmation
- Collect and Resolve Feedback from sites based on their experience using the profile
- Review & Approve then Publish 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
Getting to Stage 5: Clinically Confirmed
- Plan & Coordinate Clinical Confirmation
- Collect and Resolve Feedback
- Review & Approve then Publish Clinically Confirmed Profile
- You have reached Stage 5
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