10821 Common Compliance Issues in Conducting Clinical Research with Human Subjects

Course overview

Focuses on common compliance issues in conducting clinical research with human subjects, including the information that must be disclosed to possible research subjects as part of the informed consent process, how protocol deviations should be properly handled to ensure research compliance, and the importance of drug accountability in clinical research. Clinical trials are voluntary research studies conducted in people and are designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. The Food and Drug Administration (FDA) regulates the conduct of clinical trials, and throughout the clinical research process, it is essential for those involved to follow ethical practices to ensure that the research is performed in an unbiased manner. Adherence to the principles of good clinical practice (GCP), including human subject protection (HSP), is universally recognized as a critical requirement to the ethical conduct of research involving human subjects. Compliance issues may occur in clinical research, and it is essential that individuals involved in the research process understand how to correctly handle these situations when they do arise, as to not compromise the integrity of the research. This program discusses compliance issues that may arise during clinical research, including information that must be disclosed to possible research subjects as part of the informed consent process, how protocol deviations should be properly handled to ensure research compliance, and the importance of drug accountability in clinical research.