Reference Library

As content accumulates, we can think about appropriate organization.

• QIBA in the Literature Citations

• Guidance for Industry, Standards for Clinical Trial Imaging Endpoints, Food and Drug Administration, August 2011.
• Guidance for Industry, E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions, Food and Drug Administration, August 2011.
• Guideline on Clinical Evaluation of Diagnostic Agents, European Medicines Agency, July 2009.
  • Appendix 1 to the Guideline on Clinical Evaluation of Diagnostic Agents

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