- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
5. RESPONSIBILITIES OF THE SPONSOR
The sponsor is often a pharmaceutical company, but may also be an individual, the investigator, or an independent institution or organization that initiates, funds, organizes and oversees the conduct of a clinical trial. When the sponsor is a foreign company or organization it should have a local representative to fulfil the appropriate local responsibilities as governed by national regulations.
The sponsor is responsible for providing the investigational and comparator (if any) products, as well as appropriate information to support the safe use of those products. In addition, the sponsor is responsible for ensuring that the trial is conducted in accordance with sound scientific principles and Good Clinical Practice standards by selecting qualified investigators, providing a protocol and ensuring protocol compliance, establishing the distribution of trial-related responsibilities, and providing facilities, equipment and staff for management of the trial, record-keeping, handling of data, monitoring, and quality assurance. The sponsor is also ultimately responsible for ensuring compliance with applicable legal, ethical, and regulatory requirements (although local regulations may designate certain required activities as responsibilities of the investigator), and for providing compensation and indemnity in the event of trial-related injury or death, according to local laws and regulations.