Difference between revisions of "Process"
Jump to navigation
Jump to search
| (6 intermediate revisions by the same user not shown) | |||
| Line 16: | Line 16: | ||
===Guidance=== | ===Guidance=== | ||
* '''[[How to Write a Profile]]''' | * '''[[How to Write a Profile]]''' | ||
| − | * [[QIBA Profile Template]] | + | :* [[QIBA Profile Template]] |
| − | * [[Claim Guidance]] | + | :* [[Claim Guidance]] |
| − | * [[Assessment Procedure Guidance]] | + | :* [[Vetting Requirements]] |
| + | :* [[Expressing Requirements]] | ||
| + | :* [[Assessment Procedure Guidance]] | ||
* [[Review Process]] | * [[Review Process]] | ||
* [[Public Comment Process]] | * [[Public Comment Process]] | ||
| Line 35: | Line 37: | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft | ||
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | :* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]] | ||
| − | |||
====Getting to Stage 2: Consensus==== | ====Getting to Stage 2: Consensus==== | ||
| Line 42: | Line 43: | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile | ||
:* You have reached Stage 2 | :* You have reached Stage 2 | ||
| − | |||
====Getting to Stage 3: Technically Confirmed==== | ====Getting to Stage 3: Technically Confirmed==== | ||
| Line 51: | Line 51: | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | ||
:* You have reached Stage 3 | :* You have reached Stage 3 | ||
| − | |||
====Getting to Stage 4: Claim Confirmed==== | ====Getting to Stage 4: Claim Confirmed==== | ||
| Line 59: | Line 58: | ||
:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | :* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | ||
:* You have reached Stage 4 | :* You have reached Stage 4 | ||
| − | |||
====Getting to Stage 5: Clinically Confirmed==== | ====Getting to Stage 5: Clinically Confirmed==== | ||
| Line 66: | Line 64: | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile | ||
:* You have reached Stage 5 | :* You have reached Stage 5 | ||
| − | |||
====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==== | ||
| Line 88: | Line 84: | ||
==Conformance== | ==Conformance== | ||
* [[Profile Conformance]] | * [[Profile Conformance]] | ||
| − | + | :* [[QIBA Conformance Statement Template]] | |
| + | * [[QIBA Profile Conformance]] | ||
==See Also== | ==See Also== | ||
Revision as of 21:08, 7 December 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
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