Difference between revisions of "Process"
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| − | QIBA | + | 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 | + | The details of how those steps are carried out is described here. The [[Process Coordinating Committee]] manages this content. Comments are welcome. [mailto:qiba@rsna.org Email QIBA] |
==Committee Procedures== | ==Committee Procedures== | ||
* [[Committee Procedures]] | * [[Committee Procedures]] | ||
| − | |||
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** [[Voting Privileges]] | ** [[Voting Privileges]] | ||
| + | * [[Committee Organization]] | ||
| + | ** [[Committee Sunset Process]] | ||
| + | * [[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== |
| + | |||
| + | ===Guidance=== | ||
| + | * '''[[How to Write a Profile]]''' | ||
| + | :* [[QIBA Profile Template]] | ||
| + | :* [[Claim Guidance]] | ||
| + | :* [[Vetting Requirements]] | ||
| + | :* [[Expressing Requirements]] | ||
| + | :* [[Assessment Procedure Guidance]] | ||
| + | * [[Review Process]] | ||
| + | * [[Public Comment Process]] | ||
| + | * [[Publication Process]] | ||
| + | |||
| + | ===Process Steps=== | ||
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]] | ||
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:* Start Drafting the Profile | :* Start Drafting the Profile | ||
| − | :** See [[How to Write a Profile]] | + | :** See '''[[How to Write a Profile]]''' including specific editing guidelines |
:** 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]] | ||
| − | + | ====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 33: | Line 46: | ||
:* You have reached Stage 2 | :* You have reached Stage 2 | ||
| − | + | ====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)==== | |
| − | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation | + | :* Recruit Sites to Field Test the Profile |
| − | + | :* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]] | |
| − | :* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] | + | :* [[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]] Clinically Feasible (formerly Technically Confirmed) Profile |
:* You have reached Stage 3 | :* You have reached Stage 3 | ||
| − | + | ====Getting to Stage 4: Claim Confirmed==== | |
| − | :* [[Claim Confirmation_Process#Planning| | + | :* 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 |
| − | :* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile | + | :* 4c. Analyze Site Performance Data and assess against Profile Claim |
| + | :* 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==== | |
:* [[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]] | ||
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:* You have reached Stage 5 | :* You have reached Stage 5 | ||
| − | + | ====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]] | ||
| Line 71: | Line 85: | ||
==Conformance== | ==Conformance== | ||
* [[Profile Conformance]] | * [[Profile Conformance]] | ||
| + | :* [[QIBA Conformance Statement Template]] | ||
| + | * [[QIBA Profile Conformance]] | ||
| + | ==See Also== | ||
| + | * '''[[How To's]]''' for this Wiki | ||
| + | * [[:Category:Templates|Wiki Page Templates]] | ||
| − | |||
* [[Profile Editions]] | * [[Profile Editions]] | ||
* [[Change Tracking and File Naming]] | * [[Change Tracking and File Naming]] | ||
| − | * [[ | + | * [[Clinical Trial Planning]] |
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* [[Orphan Documents]] | * [[Orphan Documents]] | ||
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA | * [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA | ||
Revision as of 20:31, 19 July 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
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