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 candidate biomarkers, 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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The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content. Comments are welcome. [mailto:qiba@rsna.org Email QIBA]
  
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==Procedures and Conventions==
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==Committee Procedures==
  
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* [[QIBA Profile Template]]
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* [[Committee Procedures]]
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* [[Change Tracking and File Naming]]
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** [[Voting Privileges]]
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* [[Profile Editions]]
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* [[Committee Organization]]
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* [[Profile Conformance]]
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** [[Committee Sunset Process]]
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* [[Publication Process]]
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* [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
  
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* [[Committee Procedures]]
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==Profile Creation==
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** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
 
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** [[Balloting Process|Balloting Process and Voting Privileges]]
 
  
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* [[:Category:Templates|Wiki Page Templates]]
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===Guidance===
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* '''[[How to Write a Profile]]'''
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:* [[QIBA Profile Template]]
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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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* [[Review Process]]
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* [[Public Comment Process]]
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* [[Publication Process]]
  
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==QIBA Profiling Process==
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===Process Steps===
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[[Media:QIBA_Profile_Stages-20160210.pdf|QIBA Profile Stage Descriptions]] ''February 2016''
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
  
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* Selection
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====Getting to Stage 1: Public Comment====
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** [[Selection Process|Submit Proposals]]
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:* [[Selection Process|Submit Proposals]]
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** [[Selection Process|Evaluate and Approve Proposals]]
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:* [[Selection Process|Evaluate and Approve Proposals]]
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*** *[[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
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:* Start Drafting the Profile
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:** See '''[[How to Write a Profile]]''' including specific editing guidelines
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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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:* [[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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* Drafting and Public Comment Stage
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====Getting to Stage 2: Consensus====
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** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* [[Public Comment Process|Collect & Collate Public Comments]]
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** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* Reach Consensus on resolution for all comments
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** [[Review Process|Approve & Publish Public Comment Draft]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
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:* You have reached Stage 2
  
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* Publicly Reviewed Stage  
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====Getting to Stage 3: Technically Confirmed====
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** [[Public Comment Process|Collect and Resolve Public Comment]]
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:* Recruit Sites to Field Test the Profile
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*** [[Work Product for Review]]
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
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** [[Review Process|Approve & Publish Reviewed Draft]]
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:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
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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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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
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:* You have reached Stage 3
  
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* Technical Confirmation Stage
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====Getting to Stage 4: Claim Confirmed====
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** [[Confirmation Process|Distribute for Technical 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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*** [[QIBA Protocol/Profile Implementation Feedback Process]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
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** [[Review Process|Approve & Publish Technically 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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* Clinical Confirmation Stage
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====Getting to Stage 5: Clinically Confirmed====
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** [[Confirmation Process|Distribute for Clinical Confirmation]]
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:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
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** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
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** [[Review Process|Approve & Publish Clinically Confirmed Profile]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
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:* You have reached Stage 5
  
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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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** [[Media:4-Proposal for QIBA Project Categories ver8-4-10.pdf|Proposed Categories for QIBA Project Proposal Submissions]]
 
** [[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

Revision as of 21:08, 7 December 2021

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

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