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

Why Should You Attend:

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.

This webinar will show how you can determine the relationship between the study drug and an AE by accurate observation & using good medical judgment.

Areas Covered in the Seminar:

• The CFR definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more.
• How to know what an Adverse Event is and when to report it or them.
• Knowing the AE types and likelihood of finding “rare” events.
• Understanding laboratory AEs and the "Reference Range" concept.
• Common Mistakes in AE / SAE Reporting.
• Reporting of Adverse Events - when to use the AE Terminology systems.
• How to record Adverse Events and assess causality - the algorithm.

Who Will Benefit:

This Webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects.

Those benefiting the most would be:

• Principal Investigators and sub investigators
• Clinical Research Scientists (PKs, Biostatisticians, ...)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• QA / QC auditors and staff & Clinical Research Data managers

Instructor Profile:

Charles H. Pierce , MD, PhD, FCP, CPI Has 20+ years experience in bringing the message (via webinars, lectures and seminars) of Risk Management through knowledge of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects. He has been involved in Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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