Difference between revisions of "Process"
Jump to navigation
Jump to search
| (10 intermediate revisions by 3 users not shown) | |||
| Line 11: | Line 11: | ||
** [[Committee Sunset Process]] | ** [[Committee Sunset Process]] | ||
* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] | * [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] | ||
| + | * [[Media:QIBA_Conflict_of_Interest_(COI)_Policy-2021.10.28.pdf|QIBA Conflict of Interest (COI) Policy]] | ||
==Profile Creation== | ==Profile Creation== | ||
| Line 16: | Line 17: | ||
===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 33: | Line 36: | ||
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] | :** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]] | ||
:* [[Groundwork Process|Initiate/Conduct Groundwork]] | :* [[Groundwork Process|Initiate/Conduct Groundwork]] | ||
| + | :* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment | ||
:* [[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]] | ||
| Line 45: | Line 49: | ||
:* 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]] | ||
| − | |||
:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile | :* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile | ||
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile | ||
| Line 82: | Line 85: | ||
==Conformance== | ==Conformance== | ||
* [[Profile Conformance]] | * [[Profile Conformance]] | ||
| − | + | :* [[QIBA Conformance Statement Template]] | |
| + | * [[QIBA Profile Conformance]] | ||
==See Also== | ==See Also== | ||
Revision as of 18:42, 25 May 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: 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