Difference between revisions of "Process"

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(Profiling Process)
(Profiling Process)
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:* [[Selection Process|Evaluate and Approve Proposals]]
 
:* [[Selection Process|Evaluate and Approve Proposals]]
  
'''Drafting and Public Comment Stage'''
+
'''Stage 1: Drafting and Public Comment Stage'''
 
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
 
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
 
:** See [[How to Write a Profile]]
 
:** See [[How to Write a Profile]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 
:** See [[Work Product for Review]]
 
:** See [[Work Product for Review]]
 +
:* You have completed Stage 1
  
'''Consensus Stage (Publicly Reviewed)'''
+
'''Stage 2: Consensus Stage (Publicly Reviewed)'''
 
:* [[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
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
 +
:* You have completed Stage 2
  
'''Technical Confirmation Stage'''
+
'''Stage 3: Technical Confirmation Stage'''
 
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
 
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
 
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
 
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
 +
:* You have completed Stage 3
  
'''Claim Confirmation Stage'''
+
'''Stage 4: Claim Confirmation Stage'''
 
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
 
:* [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
 +
:* You have completed Stage 4
  
'''Clinical Confirmation Stage'''
+
'''Stage 5: Clinical Confirmation Stage'''
 
:* [[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]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
 +
:* You have completed Stage 5
  
 
'''Profile Maintenance'''
 
'''Profile Maintenance'''

Revision as of 00:55, 18 February 2017

Overview

QIBA attempts to industrialize biomarkers by selecting biomarkers ready for industrialization, investigating underlying sources of variance and other 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.

Committee Procedures

Profiling Process

Understand QIBA Profile Stages & QIBA Concepts

Selection

Stage 1: Drafting and Public Comment Stage

Stage 2: Consensus Stage (Publicly Reviewed)

Stage 3: Technical Confirmation Stage

Stage 4: Claim Confirmation Stage

Stage 5: Clinical Confirmation Stage

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