Process

Overview

QIBA attempts to industrialize biomarkers by selecting candidate biomarkers, 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.

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

Procedures and Conventions

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

• Committee Procedures
• Publication Process
• Balloting Process and Voting Privileges

• Wiki Page Templates

QIBA Profiling Stages

QIBA Profile Stage Descriptions 21Feb2013

• Selection Stage
  • Submit Proposals
  • Evaluate and Approve Proposals

• Drafting Stage
  • Draft Underlying UPICT Protocol
  • Draft QIBA Profile
  • Initiate/Conduct Groundwork
  • Approve & Publish Public Comment Draft

• Review Stage
  • Collect and Resolve Public Comment
  • Approve & Publish Reviewed Draft

• Technical Confirmation Stage
  • Distribute for Technical Confirmation
  • Collect and Resolve Feedback
  • Approve & Publish Technically Confirmed Profile

• Clinical Confirmation Stage
  • Distribute for Clinical Confirmation
  • Collect and Resolve Feedback
  • Approve & 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 Process
• Funding Submission Process
• Evaluation and Selection Process
• 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