Difference between revisions of "Process"

From QIBA Wiki
Jump to navigation Jump to search
(45 intermediate revisions by 2 users not shown)
Line 1: Line 1:
 
{{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. [mailto:qiba@rsna.org Email QIBA]
  
−
==Procedures and Conventions==
+
==Committee Procedures==
  
−
* [[QIBA Profile Template]]
+
* [[Committee Procedures]]
−
** [[Claim Guidance]]
+
** [[Voting Privileges]]
−
* [[Change Tracking and File Naming]]
+
* [[Review Process]]
−
* [[Profile Editions]]
 
−
* [[Profile Conformance]]
 
 
* [[Publication Process]]
 
* [[Publication Process]]
 +
* [[Public Comment Process]]
 +
* [[Committee Organization]]
 +
** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]]
  
−
* [[Committee Procedures]]
+
==Profile Creation Process==
−
** [[Media:QIBA Patent Disclosure Policy-27March2015.pdf|QIBA Patent Disclosure Policy]] ''March 2015''
+
Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
−
** [[Balloting Process|Balloting Process and Voting Privileges]]
 
  
−
* [[:Category:Templates|Wiki Page Templates]]
 
−
 
−
==QIBA Profiling Process==
 
−
[[QIBA Profile Stages]]
 
  
−
* Selection
+
:* [[Selection Process|Submit Proposals]]
−
** [[Selection Process|Submit Proposals]]
+
:* [[Selection Process|Evaluate and Approve Proposals]]
−
** [[Selection Process|Evaluate and Approve Proposals]]
 
−
*** [[Media:1-QIBA Biomarkers Selection Criteria 12-31-14.pdf|QIBA Biomarker Selection Criteria]]
 
  
−
* Drafting and Public Comment Stage
+
'''Getting to Stage 1: Public Comment'''
−
** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
+
:* Start Drafting the Profile
−
** [[Groundwork Process|Initiate/Conduct Groundwork]]
+
:** See [[How to Write a Profile]]
−
** [[Review Process|Approve & Publish Public Comment Draft]]
+
:** See [[QIBA Profile Template]] and [[Claim Guidance]] and [[Assessment Procedure Guidance]]
 +
:* [[Groundwork Process|Initiate/Conduct Groundwork]]
 +
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Public Comment Draft
 +
:* You have reached [[QIBA_Profile_Stages#Stage_1:_Public_Comment|Stage 1]]
  
−
* Consensus Stage (Publicly Reviewed)
+
'''Getting to Stage 2: Consensus'''
−
** [[Public Comment Process|Collect & Collate Comments]]
+
:* [[Public Comment Process|Collect & Collate Public Comments]]
−
*** [[Work Product for Review]]
+
:* Reach Consensus on resolution for all comments
−
** Reach Consensus on resolution for all comments
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
−
** [[Review Process|Review & Approve Consensus Profile]]
+
:* You have reached Stage 2
−
** [[Publication Process|Publish Consensus Profile]]
 
  
−
* Technical Confirmation Stage
+
'''Getting to Stage 3: Technically Confirmed'''
−
** [[Confirmation Process|Plan & Coordinate Technical Confirmation]]
+
:* [[Technical Confirmation Process#Planning|Plan & Coordinate Technical Confirmation]]
−
*** [[QIBA Protocol/Profile Implementation Feedback Process]]
+
:** See [[QIBA Protocol/Profile Implementation Feedback Process]]
−
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+
:* [[Technical Confirmation Process#Soliciting Feedback|Collect and Resolve Feedback]]
−
** [[Review Process|Review & Approve Technically Confirmed Profile]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Technically Confirmed Profile
−
** [[Publication Process|Publish Technically Confirmed Profile]]
+
:* You have reached Stage 3
  
−
* Claim Confirmation Stage
+
'''Getting to Stage 4: Claim Confirmed'''
−
** [[Confirmation Process|Plan & Coordinate Claim Confirmation]]
+
:* [[Claim Confirmation_Process#Planning|Plan & Coordinate Claim Confirmation]]
−
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+
:* [[Claim Confirmation_Process#Soliciting Feedback|Collect and Resolve Feedback]]
−
** [[Review Process|Review & Approve Claim Confirmed Profile]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
−
** [[Publication Process|Publish Claim Confirmed Profile]]
+
:* You have reached Stage 4
  
−
* Clinical Confirmation Stage
+
'''Getting to Stage 5: Clinically Confirmed'''
−
** [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
+
:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
−
** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+
:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
−
** [[Review Process|Review & Approve Clinically Confirmed Profile]]
+
:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
−
** [[Publication Process|Publish Clinically Confirmed Profile]]
+
:* You have reached Stage 5
  
−
* 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 75: Line 70:
 
** [[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
 +
 +
==Conformance==
 +
* [[Profile Conformance]]
 +
  
 
==See Also==
 
==See Also==
 +
* [[Profile Editions]]
 +
* [[Change Tracking and File Naming]]
 +
* [[:Category:Templates|Wiki Page Templates]]
 +
* '''[[How To's]]''' for this Wiki
 +
* [[Public Comment Process]]
 +
* [[Review Process]]
 +
* [[Publication Process]]
 +
* [[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
−
* [[Orphan Documents]]
 
−
* [[How to Write a Profile]]
 

Revision as of 21:11, 15 October 2018

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 Process

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

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

Retrieved from "https://qibawiki.rsna.org/index.php?title=Process&oldid=13308"