Clinical Research: REGULATORY AUTHORITY Roles and Responsibilities

The regulatory authority must act according to laws to implement and enforce the laws, Should ensure that both scientific and ethical review have been performed. It should include authority for the regulator to NOT allow the protocol to proceed or to require modification of the protocol before proceeding. The regulatory authority should implement procedures to receive, review, evaluate, and as appropriate, follow-up (e.g., by inspection) on any such complaints. Some of the other responsibilities include to ensure clear and efficient communication between committees, Ensure ongoing education of IEC members, Establish procedures for the review of protocols carried out at more than one site in a country or in more than one country, Receiving and Acting On Complaints and Ensuring Subject Rights and Safety during the Study.