Difference between revisions of "Process"

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** [[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==
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===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]]
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
 
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
'''Getting to Stage 1: Public Comment'''
+
====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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:** 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====
'''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
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:* You have reached Stage 2
 
:* You have reached Stage 2
  
 
+
====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
'''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 Clinically Feasible (formerly Technical) Confirmation]]
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
 
 
:* [[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]] Clinically Feasible (formerly 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'''
 
 
:* 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
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:* You have reached Stage 4
 
:* You have reached Stage 4
  
 
+
====Getting to Stage 5: Clinically Confirmed====
'''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====
'''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'''
 
 
:* [[Retirement Process|Review for Retirement]]
 
:* [[Retirement Process|Review for Retirement]]
  
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==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]]
  
==See Also==
 
 
* [[Profile Editions]]
 
* [[Profile Editions]]
 
* [[Change Tracking and File Naming]]
 
* [[Change Tracking and File Naming]]
* [[:Category:Templates|Wiki Page Templates]]
 
* '''[[How To's]]''' for this Wiki
 
* [[Public Comment Process]]
 
* [[Review Process]]
 
* [[Publication Process]]
 
 
* [[Clinical Trial Planning]]
 
* [[Clinical Trial Planning]]
  
 
* [[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

Latest 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

Profile Creation

Guidance

Process Steps

Understand QIBA Profile Stages & QIBA Concepts

Getting to Stage 1: Public Comment

Getting to Stage 2: Consensus

Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)

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

Profile Maintenance

Profile Retirement

Groundwork Projects and Funding

Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.

Conformance

See Also