- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
4.4 Compliance with the protocol
The investigator must agree and sign the protocol (or another legally acceptable document mentioning the agreement with the protocol) with the sponsor, and confirm in writing that he or she has read, understands and will work according to the protocol and Good Clinical Practice.
The investigator is responsible for ensuring that the protocol is strictly followed. The investigator should not make any changes in the study without the agreement of the sponsor, except when necessary to eliminate an apparent immediate hazard or danger to a trial subject. Any change should be in the form of a protocol amendment, appended to the original protocol and signed by the investigator and the sponsor. Amendments which are likely to affect the safety of a subject or the conduct of the clinical trial should be submitted in writing to the ethics committee (see Section 3.2) and drug regulatory authority and implemented only after approval has been received.
The investigator may take any steps judged necessary to protect the safety of the trial subject, whether specified in the protocol or not. Any such steps must be documented.