Difference between revisions of "Process"

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(Profiling Process)
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'''Drafting and Public Comment Stage'''
 
'''Drafting and Public Comment Stage'''
 
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
 
:* [[QIBA Profile Drafting Process|Draft QIBA Profile]]
:** [[How to Write a Profile]]
+
:** See [[How to Write a Profile]]
:** [[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]]
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
:** [[Work Product for Review]]
+
:** See [[Work Product for Review]]
  
 
'''Consensus Stage (Publicly Reviewed)'''
 
'''Consensus Stage (Publicly Reviewed)'''
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'''Technical Confirmation Stage'''
 
'''Technical Confirmation Stage'''
 
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
 
:* [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
:** [[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

Revision as of 00:51, 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

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