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.
All Clinical Research protocols have a prominent safety monitoring "plan" as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data. 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 vulnerability of the study population, the length of the study, or the number of sites conducting the clinical study. The "Plan" increasingly has the "Charter" of what is called a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB).
Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential.
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.
Deviations and Violations from the agreed upon protocol may very well affect the scientific validity of the research. For this reason, a well-written protocol, taking onto account the role of all the Inclusion and Exclusion criteria in subject enrollment is a key element in having deviation free study conduct.