Category: Participants FAQs

What is provided to regulatory agencies in order to conduct a clinical study

Any clinical trial may start only once the given country regulatory body (or health authorities) has approved and authorized the study, and once the ethics committee approvals are obtained.

Government agencies tasked with clinical trial oversight have the mission to improve and maintain the health of their population. Their evaluations focus on the product, the rationale of the study and examinations to be carried out during the study.

The Ethics Committee independently reviews all the ethical aspects of the study to protect the rights and well-being of research subjects.

Any change to an on-going study must be approved by an ethics committee and, depending on the type of change, the regulatory body, before being implemented.

It is the duty of the company developing the medication, the organisation managing the study, and the study doctor, to report to the ethics committee and to the country regulatory body, any new information that may have an impact on the proper study conduct or on the safety and well-being of the subject.

Before starting a clinical trial, a form confirming the selection of the study doctor must be forwarded to Health authorities. This document states that the physician will conduct the study in accordance with Good Clinical Practice (GCP), a standard that ensures that the rights, the safety and well-being of subjects are respected. Moreover, in order to monitor and ensure compliance of GCP and compliance with legal requirements, inspections at clinical sites can be conducted at any time by a government agency, either domestic or foreign.