Process

Overview

QIBA attempts to industrialize biomarkers by selecting biomarkers ready for industrialization, 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.

Committee Procedures

• Committee Procedures
  • QIBA Patent Disclosure Policy March 2015
  • Balloting Process
  • Voting Process
  • Voting Privileges

Profiling Process

Understand QIBA Profile Stages & QIBA Concepts

Selection

• Submit Proposals
• Evaluate and Approve Proposals

Drafting and Public Comment Stage

• Draft QIBA Profile
  • How to Write a Profile
  • QIBA Profile Template and Claim Guidance and Assessment Procedure Guidance
• Initiate/Conduct Groundwork
• Review & Approve then Publish Public Comment Draft
  • Work Product for Review

Consensus Stage (Publicly Reviewed)

• Collect & Collate Public Comments
• Reach Consensus on resolution for all comments
• Review & Approve then Publish Consensus Profile

Technical Confirmation Stage

• Plan & Coordinate Technical Confirmation
  • QIBA Protocol/Profile Implementation Feedback Process
• Collect and Resolve Feedback
• Review & Approve then Publish Technically Confirmed Profile

Claim Confirmation Stage

• Plan & Coordinate Claim Confirmation
• Collect and Resolve Feedback
• Review & Approve then Publish Claim Confirmed Profile

Clinical Confirmation Stage

• Plan & Coordinate Clinical Confirmation
• Collect and Resolve Feedback
• Review & Approve then Publish Clinically Confirmed Profile

Profile Maintenance

• Accept and Resolve Change Proposals
• (Optional) Solicit and Resolve Additional Feedback

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

See Also

• Profile Editions
• Change Tracking and File Naming
• Wiki Page Templates
• How To's for this Wiki
• Public Comment Process
• Review Process
• Publication Process

• Orphan Documents
• Profile Development Process Comparison - Considering analogs between DICOM, IHE, UPICT and QIBA