What's New

The following links have been added to the Clinical Trials Manual and are also posted in the "Relevant Links" section of the manual.

Guidance documents

• E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
• Guidance Document: Submission of Pharmacogenomic Information
• Guidance Document: Factors Considered in the Assessment of Risks Involved in the Use of Positron Emitting Radiopharmaceuticals in Basic Research Involving Humans
• Guidance Policy: Use of Positron Emitting Radiopharmaceuticals in Basic Research Policy

Useful Internet Websites

• Blueprint for Renewal
• Progressive Licensing Project
• Registration and Disclosure of Clinical Trial Information
• Review of the Regulatory Framework for Clinical Trials