- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.9 Review by an ethics committee
Prior to its commencement, the investigator must ensure that the proposed clinical trial has been reviewed and accepted in writing by the relevant independent ethics committee(s) (see Section 3.2). Any submission to and acceptance by the ethics committee should be in writing and dated, and contain sufficient information to identify the protocol or other submitted documents.