Difference between revisions of "Process"

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==Overview==
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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.
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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.
 
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The details of how those steps are carried out is described here.  The '''[[Process Coordinating Committee]]''' manages this content.
 
  
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==Procedures and Conventions==
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The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content.  Comments are welcome.
  
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* [[Change Tracking and File Naming]]
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==Committee Procedures==
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* [[Profile Editions]]
 
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* [[Profile Conformance]]
 
  
 
* [[Committee Procedures]]
 
* [[Committee Procedures]]
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** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
 
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** [[Balloting Process]]
 
 
** [[Voting Privileges]]
 
** [[Voting Privileges]]
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* [[Committee Organization]]
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** [[Committee Sunset Process]]
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* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
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* [[Media:QIBA Conflict of Interest (COI) Policy-2021.10.28.pdf|QIBA Conflict of Interest (COI) Policy]]
  
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* [[:Category:Templates|Wiki Page Templates]]
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==Profile Creation==
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==QIBA Profiling Process==
 
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[[QIBA Profile Stages]]
 
  
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* Selection
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===Guidance===
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** [[Selection Process|Submit Proposals]]
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* '''[[How to Write a Profile]]'''
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** [[Selection Process|Evaluate and Approve Proposals]]
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:* [[QIBA Profile Template]]
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*** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
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:* [[Claim Guidance]]
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:* [[Vetting Requirements]]
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:* [[Expressing Requirements]]
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:* [[Assessment Procedure Guidance]]
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:* [[Profile Editions]]
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* [[Review Process]]
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* [[Public Comment Process]]
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* [[Publication Process]]
  
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* Drafting and Public Comment Stage
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===Process Steps===
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** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
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*** [[QIBA Profile Template]] and [[Claim Guidance]]
 
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** [[Groundwork Process|Initiate/Conduct Groundwork]]
 
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** [[Review Process|Approve & Publish Public Comment Draft]]
 
  
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* Consensus Stage (Publicly Reviewed)
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====Getting to Stage 1: Public Comment====
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** [[Public Comment Process|Collect & Collate Comments]]
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:* [[Selection Process|Submit Proposals]]
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*** [[Work Product for Review]]
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:* [[Selection Process|Evaluate and Approve Proposals]]
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** Reach Consensus on resolution for all comments
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:* Start Drafting the Profile
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** [[Review Process|Review & Approve Consensus Profile]]
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:** See '''[[How to Write a Profile]]''' including specific editing guidelines
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** [[Publication Process|Publish Consensus Profile]]
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:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
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:* [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Vetting Requirements|Vet your Requirements]] before publishing for Public Comment
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
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:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
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* Technical Confirmation Stage
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====Getting to Stage 2: Consensus====
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** [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
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:* [[Public Comment Process|Collect & Collate Public Comments]]
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*** [[QIBA Protocol/Profile Implementation Feedback Process]]
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:* Reach Consensus on resolution for all comments
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
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** [[Review Process|Review & Approve Technically Confirmed Profile]]
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:* You have reached Stage 2
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** [[Publication Process|Publish Technically Confirmed Profile]]
 
  
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* Claim Confirmation Stage
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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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** [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
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:* Recruit Sites to Field Test the Profile
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
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** [[Review Process|Review & Approve Claim Confirmed Profile]]
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:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
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** [[Publication Process|Publish Claim Confirmed Profile]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile
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:* You have reached Stage 3
  
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* Clinical Confirmation Stage
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====Getting to Stage 4: Claim Confirmed====
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** [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
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:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
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** [[Review Process|Review & Approve Clinically Confirmed Profile]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
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** [[Publication Process|Publish Clinically Confirmed Profile]]
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:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
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:* You have reached Stage 4
  
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* Maintenance
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====Profile Maintenance====
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** [[Maintenance Process|Accept and Resolve Change Proposals]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
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** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
  
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* Retirement
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====Profile Retirement====
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** [[Retirement Process|Review for Retirement]]
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:* [[Retirement Process|Review for Retirement]]
  
 
==Groundwork Projects and Funding==
 
==Groundwork Projects and Funding==
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* [[Groundwork Process]]
 
* [[Groundwork Process]]
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** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
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**[[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
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** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
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**[[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
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==Conformance==
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* [[Profile Conformance]]
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:* [[QIBA Conformance Statement Template]]
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* [[QIBA Profile Conformance]]
  
 
==See Also==
 
==See Also==
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* '''[[How To's]]''' for this Wiki
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* [[:Category:Templates|Wiki Page Templates]]
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* [[Profile Editions]]
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* [[Change Tracking and File Naming]]
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* [[Clinical Trial Planning]]
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* [[Orphan Documents]]
 
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA
 
* [https://docs.google.com/document/edit?id=1TG5bHj9yTsYpHuMRt8R9T12Ml_08Ah599oxgOsiXyrg&hl=en&authkey=CJbfqekH Profile Development Process Comparison] - Considering analogs between DICOM, IHE, UPICT and QIBA
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* [[Orphan Documents]]
 
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* [[How to Write a Profile]]
 

Latest revision as of 19:32, 19 January 2024

QIBA WIKI BLURB.jpg

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.

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

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