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Quantitative Imaging Biomarkers Alliance (QIBA)

QIBA Mission: Improve the value and practicality of quantitative biomarkers by reducing variability across devices, patients and time.

• QIBA Profiles specify methods to create biomarkers that meet a claimed performance
• QIBA Overview

The navigation box to the left provides access to:

• Profiles - Published QIBA Profiles
• Committees - QIBA Committees developing biomarker Profiles and related work
• Process - Details of the QIBA methodology
• Resource Catalog -
• Education - learn about QIBA

Claim Guidance and Profile Template Documents

Claim Guidance

• QIBA Profile Claim Guidance November 2015
• Minimum Requirements Claim Testing October 2014
• Explanation of changes to claim format July 2014

Profile Templates

• QIBA Profile Template - Word Version (Process Committee Version) December 2015

• QIBA Profile Stage Descriptions 21Feb2013

QIBA Resources

• QIBA Fact Sheet October 2015

• QIBA Governance Structure September 2015

• QIBA Task Force Report August 2011

• Guidance Standards for CTs
• Guidance biomarker qualification Aug 2011

Guidelines

• Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

• EMEA Guideline on Clinical Evaluation of Diagnostic Agents (2009.08.04)
• EMEA Guideline - Appendix 1 (2009.08.04)
• Oncology section from 2009 Imaging Biomarkers Roundtable

Quantitative Imaging/Imaging Biomarkers and QIBA Meetings and Activities

• QIBA in the Literature Citations

• Biomarker Roadmap (11-01-2010 version)

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