Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 141

In this topic area, we have outlined the roles and responsibilities of the regulatory authority within the context of the GCP Guidelines. It is meaningful to keep in perspective that while the regulatory authority is a player in the clinical trial process, as defined in GCP and has roles and responsibilities, it (the regulator) is not in large measure the focus of the GCP requirements.

The responsibilities of the regulatory authority are founded in law, regulations, and directives and are carried out by governmental agencies or their designees. It is the role of the regulatory authority to act as a gatekeeper, overseer, and evaluator using the legally mandated requirements including GCP.

The regulatory authority has a responsibility to be accountable for its actions through documentation, transparency, and clear communications with sponsors, investigators when appropriate, and IRBs/IECs.