What is the role of Data and Safety Monitoring in Clinical Research Involving Human Subjects

FREMONT, Calif. - May 13, 2013 - PRLog -- Safety monitoring is mandated in 21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices Depending on the nature of the test agent, the length of the study or the number of sites conducting the clinical study, the "Plan" may set the "Charter" of what is called a Data and Safety Monitoring Board (DSMB) or Committee (DMC). DSMB's and their composition play an increasingly important roll in both multi-center studies and where there are expected or possible adverse events. The "Stopping Rules" are an important element in the Charter. The overriding reason for a carefully selected DSMB is to promote and guarantee human subject safety.

Areas Covered in the Session:
The historical background of why Data and Safety monitoring is essential

The purpose of the Data and Safety monitoring plan

The Regulatory requirements for safety monitoring

Studies requiring a formal Safety monitoring plan

What does the "Charter" of a DSMB compose of?

What is the composition and function of a DSMB?

What types of studies "require" a DSMB?

Conflict of interest and the DSMB

Who will Benefit:
Principal Investigators and sub investigators,

Clinical Research Scientists

Safety Nurses

Clinicl Research Associates (CRAs) and Cordinators (CRCs)

Recruiting staff

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.