- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
10.4 Responsibilities of the sponsor and monitor1
1 See also sections 5 and 6.
The sponsor is responsible for:
• Supplying the investigational and, when appropriate, comparator product(s), prepared in accordance with principles of Good Manufacturing Practice. The products should be fully characterized, properly coded, and suitably packaged in such a way as to provide protection against deterioration during transport and storage at intermediate destinations; appropriate investigational labelling should be affixed (see Section 10.2).
• Ensuring that the package of investigational product(s) is of a size suitable for the trial and adequate for the trial subjects.
• Keeping sufficient samples from each batch used in the trial as a reference for control tests and validation of data, as required in national regulations.
• Providing information about the expiry date (month/year) or retest date information in a manner understandable to all staff involved in the trial.
During the visits to the clinical trial site, the monitor should check:
• That all study products for the trial are used exclusively within the limits defined by the protocol.
• That inventory records of study products are in order and that there are sufficient supplies.
• That the expiry dates are not likely to be, or have not been, exceeded.
• That the storage conditions for study products are adequate.
• Procedures for and records of returned and/or unused study products.