Difference between revisions of "Process"

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QIBA is still evolving it's processes but the following pages present current thoughts.
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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.
  
Much of this is adapted from DICOM and IHE processes.
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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]
  
==Overviews==
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==Committee Procedures==
* [[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
 
  
* [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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* [[Committee Procedures]]
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** [[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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==Profile Creation==
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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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===Process Steps===
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Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
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====Getting to Stage 1: Public Comment====
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:* [[Selection Process|Submit Proposals]]
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:* [[Selection Process|Evaluate and Approve Proposals]]
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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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:* [[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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====Getting to Stage 2: Consensus====
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:* [[Public Comment Process|Collect & Collate Public Comments]]
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:* Reach Consensus on resolution for all comments
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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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====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
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:* Recruit Sites to Field Test the Profile
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:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
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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]] Clinically Feasible (formerly Technically Confirmed) Profile
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:* You have reached Stage 3
  
==QIBA Profiling==
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====Getting to Stage 4: Claim Confirmed====
* Selection
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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)
** [[Selection Process|Submit Proposals]]
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:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
** [[Selection Process|Evaluate and Approve Proposals]]
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:* 4c. Analyze Site Performance Data and assess against Profile Claim
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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
  
* Drafting
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====Getting to Stage 5: Clinically Confirmed====
** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
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:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
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:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
** [[Groundwork Process|Initiate/Conduct Groundwork]]
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:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
** [[Review Process|Approve & Publish Public Comment Draft]]
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:* You have reached Stage 5
** [[Public Comment Process|Collect and Resolve Public Comment]]
 
  
* Field Test
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====Profile Maintenance====
** [[Review Process|Approve & Publish Reviewed Draft]]
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:* [[Maintenance Process|Accept and Resolve Change Proposals]]
** [[Trial Implementation Process|Distribute for Trial Implementation]]
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:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
 
  
* Publication and Maintenance
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====Profile Retirement====
** [[Review Process|Approve & Publish Tested Draft]]
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:* [[Retirement Process|Review for Retirement]]
** [[Maintenance Process|Accept and Resolve Change Proposals]]
 
** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Field Feedback]]
 
  
* Retirement
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==Groundwork Projects and Funding==
** [[Retirement Process|Review for Retirement]]
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[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
  
==Templates==
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* [[Groundwork Process]]
[[:Category:Templates|Wiki Templates]] are samples of certain types of Wiki pages to provide guidance and promote consistency of content/format.
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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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* Funding Submission Process
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* 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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* 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
  
Document Templates are samples of certain types of documents.
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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]]
  
:* QIBA Profile Template (2011)
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==See Also==
::* An updated version of the template will be published in late 2012 based on revisions to address feedback from the first round of profile development.
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* '''[[How To's]]''' for this Wiki
::* [https://docs.google.com/spreadsheet/ccc?key=0AkfpWndrzLS2dHg2UmlHd042QURhTndBY2I4RG1EdFE QIBA Profile Template Improvements 2012]
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* [[:Category:Templates|Wiki Page Templates]]
  
==Organizational==
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* [[Profile Editions]]
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* [[Change Tracking and File Naming]]
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* [[Clinical Trial Planning]]
  
* [[Committee Procedures]]
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* [[Orphan Documents]]
* [[Publication Process]]
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* [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
* [[Balloting Process]]
 

Latest revision as of 20:31, 19 July 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: 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

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