Difference between revisions of "Process"

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

Getting to Stage 2: Consensus

Collect & Collate Public Comments
Reach Consensus on resolution for all comments
Review & Approve then Publish Consensus Profile
You have reached Stage 2

Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)

Recruit Sites to Field Test the Profile
Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation
Collect and Resolve Feedback from sites based on their experience using the profile
Review & Approve then Publish Clinically Feasible (formerly Technically Confirmed) Profile
You have reached Stage 3

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

Plan & Coordinate Clinical Confirmation
Collect and Resolve Feedback
Review & Approve then Publish Clinically Confirmed Profile
You have reached Stage 5

Profile Maintenance

Profile Retirement

Review for Retirement

Groundwork Projects and Funding

Groundwork and Profiling - a model for linking research, validation, standardization, product implementation and deployment.

Groundwork Process
- Imaging Biomarker Roadmap for QIBA Profiles
Funding Submission Process
Evaluation and Selection Process
- 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

Conformance

Profile Conformance

QIBA Conformance Statement Template

QIBA Profile Conformance

@@ Line 1: / Line 1: @@
-__NOTOC__
+{{TOCright}}
-QIBA is still evolving its processes but the following pages present current thoughts.
+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.
+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]
-==Overview==
+==Committee Procedures==
-* [[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
-==Procedures and Conventions==
+* [[Committee Procedures]]
+** [[Voting Privileges]]
-* [[QIBA Profile Template]]
+* [[Committee Organization]]
-* [[Change Tracking and File Naming]]
+** [[Committee Sunset Process]]
-* [[Profile Editions]]
+* [[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]]
+* [[Review Process]]
+* [[Public Comment Process]]
 * [[Publication Process]]
-* [[Balloting Process]]
+===Process Steps===
+Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
-* [[:Category:Templates|Wiki Page Templates]]
+====Getting to Stage 1: Public Comment====
+:* [[Selection Process|Submit Proposals]]
+:* [[Selection Process|Evaluate and Approve Proposals]]
+:* Start Drafting the Profile
+:** 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]]
-==QIBA Profiling Stages==
+====Getting to Stage 2: Consensus====
-[[Media:QIBA Profile Stages ver 21FEB2013.doc|QIBA Profile Stage Descriptions]] ''21Feb2013''
+:* [[Public Comment Process|Collect & Collate Public Comments]]
+:* Reach Consensus on resolution for all comments
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
+:* You have reached Stage 2
-* Selection Stage
+====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
-** [[Selection Process|Submit Proposals]]
+:* Recruit Sites to Field Test the Profile
-** [[Selection Process|Evaluate and Approve Proposals]]
+:* [[Technical Confirmation Process#Planning|Plan & Coordinate Clinically Feasible (formerly Technical) Confirmation]]
+:* [[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
-* Drafting Stage
+====Getting to Stage 4: Claim Confirmed====
-** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
+:* 4a. [[Claim Confirmation_Process#Planning|Design Method to assess site performance]] (in terms of metrics in Profile Claims, e.g., wCV)
-** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
+:* 4b. Recruit sites to follow the Profile and assess site performance per 4a
-** [[Groundwork Process|Initiate/Conduct Groundwork]]
+:* 4c. Analyze Site Performance Data and assess against Profile Claim
-** [[Review Process|Approve & Publish Public Comment Draft]]
+:* 4d. [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Claim Confirmed Profile
+:* You have reached Stage 4
-* Review Stage
+====Getting to Stage 5: Clinically Confirmed====
-** [[Public Comment Process|Collect and Resolve Public Comment]]
+:* [[Confirmation Process|Plan & Coordinate Clinical Confirmation]]
-** [[Review Process|Approve & Publish Reviewed Draft]]
+:* [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Clinically Confirmed Profile
+:* You have reached Stage 5
-* Technical Confirmation Stage
+====Profile Maintenance====
-** [[Confirmation Process|Distribute for Technical Confirmation]]
+:* [[Maintenance Process|Accept and Resolve Change Proposals]]
-** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
+:* (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
-** [[Review Process|Approve & Publish Technically Confirmed Profile]]
-* Clinical Confirmation Stage
+====Profile Retirement====
-** [[Confirmation Process|Distribute for Clinical Confirmation]]
+:* [[Retirement Process|Review for Retirement]]
-** [[Trial Implementation Feedback Process|Collect and Resolve Feedback]]
-** [[Review Process|Approve & Publish Clinically Confirmed Profile]]
-* Maintenance
+==Groundwork Projects and Funding==
-** [[Maintenance Process|Accept and Resolve Change Proposals]]
+[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
-** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
-* Retirement
+* [[Groundwork Process]]
-** [[Retirement Process|Review for Retirement]]
+** [[Media:3-Proposed Imaging Biomarker Roadmap For QIBA Profiles Dec2014.pdf|Imaging Biomarker Roadmap for QIBA Profiles]]
+* Funding Submission 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
+==Conformance==
+* [[Profile Conformance]]
+:* [[QIBA Conformance Statement Template]]
+* [[QIBA Profile Conformance]]
 ==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

Difference between revisions of "Process"

Revision as of 20:31, 19 July 2022

Contents

Committee Procedures

Profile Creation

Guidance

Process Steps

Getting to Stage 1: Public Comment