Clinical Trials

A clinical trial is an investigation in respect of a drug for use in humans that involves human subjects and that is intended to discover or verify the clinical, pharmacological or pharmacodynamic effects of the drug, identify any adverse events in respect of the drug, study the absorption, distribution, metabolism and excretion of the drug, or ascertain the safety or efficacy of the drug.

• Guidance Document Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals
• Overview of the Clinical Trial Application Process
• Clinical Trial Applications
• Institution / Investigator Initiated Clinical Trials
• Accountability and Transparency
• Relevant Links
• Abbreviations / Definitions
• Frequently Asked Questions
• Quiz