How Accurate Adverse Event Reporting is the Key to Subject Safety of Approved Drugs?

FREMONT, Calif. - June 12, 2013 - PRLog -- Overview: The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.

AE's are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To obtain 'commonality' in reporting, investigative sites require familiarity 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.
See Why determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).

Why Should You Attend: With the increasing complexity of the Investigational Medicinal Products (IMP's), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.

Areas Covered in the Session:
The 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 and to whom and the use of AE Terminology systems
How to record Adverse Events and assess causality - the algorithm

Who Will Benefit:
Principal Investigators and sub investigators
Clinical Research Scientists
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
QA / QC auditors and staff
Clinical Research Data Managers

Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message 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. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich. He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.