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]]'''
:* [[Profile Writing Guidelines]]
 
 
:* [[QIBA Profile Template]]
 
:* [[QIBA Profile Template]]
 
:* [[Claim Guidance]]
 
:* [[Claim Guidance]]
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:* [[Vetting Requirements]]
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:* [[Expressing Requirements]]
 
:* [[Assessment Procedure Guidance]]
 
:* [[Assessment Procedure Guidance]]
 
* [[Review Process]]
 
* [[Review 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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==Conformance==
 
==Conformance==
 
* [[Profile Conformance]]
 
* [[Profile Conformance]]
 
+
:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
 
==See Also==
 
==See Also==

Latest revision as of 14:49, 20 January 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: 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