Privacy Regulations Impact On Global Clinical Trial Endpoint Adjudication

By: James Riddle, MCSE, CIP, CPIA, CRQM, VP of Research Services & Strategic Consulting

Endpoint adjudication committees (EACs), also called clinical event committees (CECs), play a critical role in clinical trials by reviewing and confirming the occurrence of clinical endpoints—or when a clinical threshold has been met or an event occurs that needs to be categorized. EAC/CECs also gather and examine potentially identifiable research data from all over the world, which requires staying abreast of rapidly developing privacy regulations.

In the United States, the Health Insurance Portability and Accountability Act (HIPAA) is the primary privacy regulation governing the use and disclosure of health information. However, there are also several state-specific privacy regulations that EAC/CECs must be aware of, as well as privacy regulations in other countries. This can be a challenge, as there is no single global privacy standard.

By staying compliant with privacy regulations and implementing a robust data security program, EAC/CECs can help to protect the privacy of research participants and ensure the compliance of clinical trials. Explore the challenges faced by EAC/CECs in complying with privacy regulations and the solutions they use to support worldwide clinical trials.