- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
- Keywords > clinical trials
- Keywords > clinical trials - social, legal and ethical implications
- Keywords > clinical trials in humans
- Keywords > controlled clinical trials
- Keywords > ethical practices and standards
- Keywords > GCP for trials on pharmaceutical products
- Keywords > Good Clinical Practice (GCP)
- Keywords > investigational product - clinical trials
- Keywords > WHO expert committee
(1995; 36 pages) [French] [Spanish]
5.3 Compliance with the protocol and procedures
The sponsor is responsible for assuring the investigator’s agreement to undertake the clinical trial as described in the protocol, and according to Good Clinical Practice, and to accept procedures for data recording (particularly in the case-report form or CRF), monitoring, audits, and inspections. The sponsor and the investigator must sign the protocol or an alternative document confirming this agreement.
Both the sponsor and the investigator should agree to any amendment to the protocol before it is implemented and this should be documented in writing.
Amendments which may affect the safety of the subjects or the conduct of the trial should be submitted in writing to the ethics committee (see Section 3.2) through the investigator or, if applicable, directly by the sponsor. The sponsor should provide justification for the amendments. If required, the amendments should be submitted to the drug regulatory authority. The amendments should not be implemented until all required approvals have been obtained, unless the delay caused by this process is likely to expose the subjects to an immediate hazard or danger.