- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Quality and Safety: Medicines > Safety and Efficacy
(1993; 94 pages)
RESPONSIBILITIES OF THE SPONSOR
If the product under investigation is supplied by a manufacturer, or if the trial is undertaken at the request of a manufacturer, the manufacturer (sponsor) has obligations to maintain the integrity of the investigators, the protocol group and the ethics review board, and to prevent harm to a patient. The sponsor of a study can be an institution or an individual investigator as well as a manufacturer.
The material supplied for the trial will be prepared according to Good Manufacturing Practices (GMP) to ensure the quality of the material used in the investigation. All data on the product will be made available to the investigator before the trial design is completed.
The sponsor must meet all of the local requirements set by regulatory authorities and government agencies and should be aware of standards of good clinical practice.