clinical Training 2011 - How Due Diligence in Accurate Adverse Event Reporting is the Key to a clean FDA Audit

This training on Adverse Event Reporting in Clinical Trials will show how to accurately observe and report AEs and SAEs, avoid common mistakes in AE / SAE reporting and successfully clear an FDA audit.

Presently, there is an increase in real-time FDA Audits of trials and it seems that no one is well prepared. It is the obligation of the major players in the drug development process (the Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and mistakes are found and corrected. The most important subject safety error is to incorrectly observing and reporting Adverse Events even SAEs.

AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. In this training, we will discuss how to obtain 'commonality' in reporting by familiarizing investigative sites with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug.