In this Data Monitoring Committees (DMCs) training for Clinical Research learn why the increase in using Data Monitoring Committees (DMCs) in Clinical Research affects Subject-public Safety: How they are set up to be effective?
Why Should You Attend:
Data Monitoring Committees (DMCs, DSMBs) are increasingly seen as an integral part of multi centered trials. They are set-up by the sponsors of the research but impact every level of the process. Safety monitoring is mandated throughout the regulations (21 CFR 312.50, 312.56, and 600.80 for drugs and biologics and 21 CFR 812.40 and 812.46 for devices) and depends on the nature of the test agent, the vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study.
Attend this Webinar to learn how the key to their function is as an unblinded oversight group that is independent, confidence and an absolute absence of any Conflicts of Interest.The FDA has increasingly recommended and sometimes mandated that a DMC be involved to advise the sponsor regarding subject safety. The "Stopping Rules" are an important element in a DMC function. Learn why the overriding reasons for a carefully selected (no Conflict of Interest) unblinded, independent, statistician controlled DMC is to promote and guarantee human subject safety as well as data integrity.
Areas Covered in the Seminar:
- 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 Committees.
- What does the "Charter" of a DMC compose of?
- What is the composition and function of a DMC?
- What types of studies "require" a DMC?
- Conflict of interest and the DMC
Who Will Benefit:
This Webinar will provide invaluable assistance to industry study sponsors and those involved in setting up DMCs regarding 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 / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses.
- Clinical Research Associates (CRAs) and Coordinators (CRCs).
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
Instructor Profile:
Charles H. Pierce, MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing 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. Dr. Pierce serves as an advisor to several clinical research organizations. 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.
