- 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]
5.2 Delegation of responsibilities
The sponsor is responsible for agreeing with the investigator(s) on the allocation of protocol-related responsibilities, including data processing, breaking of the trial code, handling of statistics, preparation of trial reports, and preparation and submission of documentation to the ethics committee, the drug regulatory authority, and any other required review bodies. This agreement should be confirmed in writing (protocol, contract, or alternative document) prior to the trial.
The sponsor may transfer any or all clinical trial-related activities to a scientific body (commercial, academic, or other), or to a contract research organization (CRO). Any such transfer should be documented in writing.