Process

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

• Committee Procedures
  • Voting Privileges
• Committee Organization
  • Committee Sunset Process
• QIBA Patent Disclosure Policy
• 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

• Review Process
• Public Comment Process
• Publication Process

Process Steps

Understand QIBA Profile Stages & QIBA Concepts

Getting to Stage 1: Public Comment

• Submit Proposals
• 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
• Initiate/Conduct Groundwork
• Vet your Requirements before publishing for Public Comment
• Review & Approve then Publish Public Comment Draft
• You have reached Stage 1

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 Technical Confirmation
• Collect and Resolve Feedback from sites based on their experience using the profile
• Review & Approve then Publish 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

• 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

• QIBA Conformance Statement Template

• QIBA Profile Conformance

See Also

• How To's for this Wiki
• Wiki Page Templates

• Profile Editions
• Change Tracking and File Naming
• Clinical Trial Planning

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