What is the role of a regulatory authority in clinical trials?

The role of a regulatory authority in clinical trials is fundamentally connected to oversight and compliance. Regulatory authorities are responsible for ensuring that clinical trials are conducted according to established regulations and guidelines, which include Good Clinical Practice (GCP) principles. This involves verifying that the trials adhere to ethical standards, protecting the rights and welfare of participants, and ensuring that the data generated is accurate and reliable.

By overseeing compliance, these authorities work to validate that all aspects of the trial—from protocol adherence to data handling—meet the necessary legal and ethical standards. This scrutiny ultimately helps to maintain public trust in the clinical research process and ensures that the findings from the trials are credible and usable for decision-making in healthcare.

The other options, while related to aspects of clinical trials, do not accurately represent the primary function of regulatory authorities. Conducting trials directly, managing funding and resources, and developing trial protocols are typically the responsibilities of sponsors, investigators, and research organizations, not regulatory bodies.