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.

Procedures and Conventions

• Change Tracking and File Naming
• Profile Editions
• Profile Conformance

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

• Wiki Page Templates

QIBA Profiling Process

QIBA Profile Stages

• Selection
  • Submit Proposals
  • Evaluate and Approve Proposals
    • QIBA Biomarker Selection Criteria

• Drafting and Public Comment Stage
  • Draft QIBA Profile
    • QIBA Profile Template and Claim Guidance
  • Initiate/Conduct Groundwork
  • Approve & Publish Public Comment Draft

• Consensus Stage (Publicly Reviewed)
  • Collect & Collate Comments
    • Work Product for Review
  • Reach Consensus on resolution for all comments
  • Review & Approve Consensus Profile
  • Publish Consensus Profile

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

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

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

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

• 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

See Also

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