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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:* [[Claim Guidance]]
 
:* [[Claim Guidance]]
 
:* [[Vetting Requirements]]
 
:* [[Vetting Requirements]]
:* [[Profile Writing Guidelines|Expressing Requirements]]
+
:* [[Expressing Requirements]]
 
:* [[Assessment Procedure Guidance]]
 
:* [[Assessment Procedure Guidance]]
 +
:* [[Profile Editions]]
 
* [[Review Process]]
 
* [[Review Process]]
 
* [[Public Comment Process]]
 
* [[Public Comment Process]]
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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]]
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:* You have reached Stage 2
 
:* You have reached Stage 2
  
====Getting to Stage 3: Technically Confirmed====
+
====Getting to Stage 3: Clinically Feasible (formerly 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
  
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:* 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====
 
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
 
:* You have reached Stage 5
 
  
 
====Profile Maintenance====
 
====Profile Maintenance====
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* [[Groundwork Process]]
 
* [[Groundwork Process]]
** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
+
**[[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
 
* Funding Submission Process
 
* Funding Submission Process
 
* Evaluation and Selection Process
 
* Evaluation and Selection Process
** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
+
**[[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
 
* 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
 
* 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
  

Latest revision as of 19:21, 8 November 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

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