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.