Difference between revisions of "Process"

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(Procedures and Conventions)
(QIBA Profiling Process)
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:** [[QIBA Profile Template]] and [[Claim Guidance]]
 
:** [[QIBA Profile Template]] and [[Claim Guidance]]
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
 
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
:* [[Review Process|Review & Approve]] Public Comment Draft then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 
:** [[Work Product for Review]]
 
:** [[Work Product for Review]]
  
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:* [[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]] Consensus Profile then [[Publication Process|Publish]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
  
 
'''Technical Confirmation Stage'''
 
'''Technical Confirmation Stage'''
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:** [[QIBA Protocol/Profile Implementation Feedback Process]]
 
:** [[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]] Technically Confirmed Profile then [[Publication Process|Publish]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
  
 
'''Claim Confirmation Stage'''
 
'''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]] Claim Confirmed Profile then [[Publication Process|Publish]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
  
 
'''Clinical Confirmation Stage'''
 
'''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]] Clinically Confirmed Profile then [[Publication Process|Publish]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
  
 
'''Profile Maintenance'''
 
'''Profile Maintenance'''

Revision as of 02:10, 4 January 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.

Procedures and Conventions

QIBA Profiling Process

QIBA Profile Stages & QIBA Concepts

Selection

Drafting and Public Comment Stage

Consensus Stage (Publicly Reviewed)

Technical Confirmation Stage

Claim Confirmation Stage

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