In relation to clinical trials, compliance (adherence) most often refers to how well a participant in a study follows the instructions of the protocol. In the case of a clinical trial studying a new drug, full participant compliance would include consistently taking the correct dosage of the therapy at the correct times and participating in all scheduled follow-up testing and visits. Non-compliance, especially if unreported to the clinical trial team, can result in incorrect conclusions concerning the efficacy and safety of the therapy being studied.
In addition, the U.S. Food and Drug Administration (FDA) monitors investigators’ compliance with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and, for research involving human subjects, to help protect the rights, safety, and welfare of those subjects.
The Secrets of a Successful Clinical Trial: Compliance, Compliance, and Compliance [2011 published article]
U.S. Food and Drug Administration (FDA): Clinical Investigations Compliance & Enforcement
U.S. Food and Drug Administration (FDA): Clinical Investigators – Disqualification Proceedings