Difference between revisions of "Process"

Latest revision as of 19:32, 19 January 2024

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

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

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__
+[[Image:QIBA_WIKI_BLURB.jpg|600px]]
-QIBA is still evolving it's processes but the following pages present current thoughts.
-Much of this is adapted from DICOM and IHE processes.
+{{TOCright}}
+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.
-==Overviews==
+The details of how those steps are carried out is described here.  The [[Process Coordinating Committee]] manages this content.  Comments are welcome.
-* [[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
+==Committee Procedures==
+* [[Committee Procedures]]
+** [[Voting Privileges]]
+* [[Committee Organization]]
+** [[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==
+===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]]
+===Process Steps===
+Understand [[QIBA Profile Stages]] & [[QIBA Concepts]]
-==QIBA Profiling==
+====Getting to Stage 1: Public Comment====
-* Selection
+:* [[Selection Process|Submit Proposals]]
-** [[Selection Process|Submit Proposals]]
+:* [[Selection Process|Evaluate and Approve 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]]
-* Drafting
+====Getting to Stage 2: Consensus====
-** [[UPICT Protocol Drafting Process|Draft Underlying UPICT Protocol]]
+:* [[Public Comment Process|Collect & Collate Public Comments]]
-** [[QIBA Profile Drafting Process|Draft QIBA Profile]]
+:* Reach Consensus on resolution for all comments
-** [[Groundwork Process|Initiate/Conduct Groundwork]]
+:* [[Review Process|Review & Approve]] then [[Publication Process|Publish]] Consensus Profile
-** [[Review Process|Approve & Publish Public Comment Draft]]
+:* You have reached Stage 2
-* Review
+====Getting to Stage 3: Clinically Feasible (formerly Technically Confirmed)====
-** [[Public Comment Process|Collect and Resolve Public Comment]]
+:* Recruit Sites to Field Test the Profile
-** [[Review Process|Approve & Publish Reviewed Draft]]
+:* [[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
-* Technical Confirmation
+====Getting to Stage 4: Claim Confirmed====
-** [[Confirmation Process|Distribute for Technical 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 Technically Confirmed Draft]]
+:* 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
-* Clinical Confirmation
+====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 Clinically Confirmed Draft]]
-* Maintenance
+====Profile Retirement====
-** [[Maintenance Process|Accept and Resolve Change Proposals]]
+:* [[Retirement Process|Review for Retirement]]
-** (Optional) [[Trial Implementation Feedback Process|Solicit and Resolve Additional Feedback]]
-* Retirement
+==Groundwork Projects and Funding==
-** [[Retirement Process|Review for Retirement]]
+[[Groundwork and Profiling]] - a model for linking research, validation, standardization, product implementation and deployment.
-==Templates==
+* [[Groundwork Process]]
-[[:Category:Templates|Wiki Templates]] are samples of certain types of Wiki pages to provide guidance and promote consistency of content/format.
+**[[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
-Document Templates are samples of certain types of documents.
+==Conformance==
+* [[Profile Conformance]]
+:* [[QIBA Conformance Statement Template]]
+* [[QIBA Profile Conformance]]
-:* QIBA Profile Template (2011)
+==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.
+* '''[[How To's]]''' for this Wiki
-::* [https://docs.google.com/spreadsheet/ccc?key=0AkfpWndrzLS2dHg2UmlHd042QURhTndBY2I4RG1EdFE QIBA Profile Template Improvements 2012]
+* [[:Category:Templates|Wiki Page Templates]]
-==Organizational==
+* [[Profile Editions]]
+* [[Change Tracking and File Naming]]
+* [[Clinical Trial Planning]]
-* [[Committee Procedures]]
+* [[Orphan Documents]]
-* [[Publication Process]]
+* [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]]

Difference between revisions of "Process"

Latest revision as of 19:32, 19 January 2024

Contents

Committee Procedures

Profile Creation

Guidance

Process Steps

Getting to Stage 1: Public Comment