ABOUT THIS EVENT (Hosted by CDER SBIA)

This is a recording (video, audio and slides) of the Annual FDA training for investigators, sponsors and regulators on GCP, inspections, data integrity, and regulatory requirements.

The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.

Participants will acquire a practical understanding of:

• FDA’s approach to trial design
• Statistical issues in the analysis of trial data
• Safety concerns in the development of medical products
• Understanding preclinical information relevant to medical product development
• Clinical investigator responsibilities