Difference between revisions of "Process"

From QIBA Wiki
Jump to navigation Jump to search
m
 
(87 intermediate revisions by 5 users not shown)
Line 1: Line 1:
 +
[[Image:QIBA_WIKI_BLURB.jpg|600px]]
 +
 
{{TOCright}}
 
{{TOCright}}
−
==Overview==
+
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.
−
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.
 
  
−
The details of how those steps are carried out is described here.  The '''[[Process Coordinating Committee]]''' manages this content.
+
The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content.  Comments are welcome.  
  
−
==Procedures and Conventions==
+
==Committee Procedures==
  
−
* [[QIBA Profile Template]]
+
* [[Committee Procedures]]
−
* [[Change Tracking and File Naming]]
+
** [[Voting Privileges]]
−
* [[Profile Editions]]
+
* [[Committee Organization]]
−
* [[Profile Conformance]]
+
** [[Committee Sunset Process]]
 +
* [[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==
  
−
* [[Committee Procedures]]
+
===Guidance===
 +
* '''[[How to Write a Profile]]'''
 +
:* [[QIBA Profile Template]]
 +
:* [[Claim Guidance]]
 +
:* [[Vetting Requirements]]
 +
:* [[Expressing Requirements]]
 +
:* [[Assessment Procedure Guidance]]
 +
:* [[Profile Editions]]
 +
* [[Review Process]]
 +
* [[Public Comment Process]]
 
* [[Publication Process]]
 
* [[Publication Process]]
−
* [[Balloting Process|Balloting Process and Voting Privileges]]
 
−
 
−
* [[:Category:Templates|Wiki Page Templates]]
 
−
 
−
==QIBA Profiling Stages==
 
−
[[Media:QIBA_Profile_Stages-20160210.pdf|QIBA Profile Stage Descriptions]] ''February 2016''
 
  
−
* Selection Stage
+
===Process Steps===
−
** [[Selection Process|Submit Proposals]]
+
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
−
** [[Selection Process|Evaluate and Approve Proposals]]
 
  
−
* Drafting Stage
+
====Getting to Stage 1: Public Comment====
−
** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
+
:* [[Selection Process|Submit Proposals]]
−
** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
+
:* [[Selection Process|Evaluate and Approve Proposals]]
−
** [[Groundwork Process|Initiate/Conduct Groundwork]]
+
:* Start Drafting the Profile
−
** [[Review Process|Approve & Publish Public Comment Draft]]
+
:** See '''[[How to Write a Profile]]''' including specific editing guidelines
 +
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
 +
:* [[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
 +
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
−
* Review Stage
+
====Getting to Stage 2: Consensus====
−
** [[Public Comment Process|Collect and Resolve Public Comment]]
+
:* [[Public Comment Process|Collect & Collate Public Comments]]
−
** [[Review Process|Approve & Publish Reviewed Draft]]
+
:* Reach Consensus on resolution for all comments
 +
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
 +
:* You have reached Stage 2
  
−
* Technical Confirmation Stage
+
====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
−
** [[Confirmation Process|Distribute for Technical Confirmation]]
+
:* Recruit Sites to Field Test the Profile
−
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
−
** [[Review Process|Approve & Publish Technically Confirmed Profile]]
+
:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]] from sites based on their experience using the profile
 +
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Feasible (formerly Technically Confirmed) Profile
 +
:* You have reached Stage 3
  
−
* Clinical Confirmation Stage
+
====Getting to Stage 4: Claim Confirmed====
−
** [[Confirmation Process|Distribute for Clinical Confirmation]]
+
:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)
−
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+
:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
−
** [[Review Process|Approve & Publish Clinically Confirmed Profile]]
+
:* 4c. Analyze Site Performance Data and assess against Profile Claim
 +
:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
 +
:* You have reached Stage 4
  
−
* Maintenance
+
====Profile Maintenance====
−
** [[Maintenance Process|Accept and Resolve Change Proposals]]
+
:* [[Maintenance Process|Accept and Resolve Change Proposals]]
−
** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
+
:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
  
−
* Retirement
+
====Profile Retirement====
−
** [[Retirement Process|Review for Retirement]]
+
:* [[Retirement Process|Review for Retirement]]
  
 
==Groundwork Projects and Funding==
 
==Groundwork Projects and Funding==
Line 57: Line 74:
  
 
* [[Groundwork Process]]
 
* [[Groundwork Process]]
 +
**[[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
 +
**[[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
 +
 +
==Conformance==
 +
* [[Profile Conformance]]
 +
:* [[QIBA Conformance Statement Template]]
 +
* [[QIBA Profile Conformance]]
  
 
==See Also==
 
==See Also==
 +
* '''[[How To's]]''' for this Wiki
 +
* [[:Category:Templates|Wiki Page Templates]]
 +
 +
* [[Profile Editions]]
 +
* [[Change Tracking and File Naming]]
 +
* [[Clinical Trial Planning]]
 +
 +
* [[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

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

Retrieved from "https://qibawiki.rsna.org/index.php?title=Process&oldid=19638"