The arrangements made by the sponsor to supply the investigator with pharmaceutical products for the trial should be described in the protocol. The manner in which study products are to be recorded, delivered, dispensed and stored should be detailed.
The principles of Good Manufacturing Practice (1) should be applied not only by the supplier of the pharmaceutical product(s), but also by any intermediaries responsible for storing the product(s) temporarily.
Records must be kept of information about the shipment, delivery, receipt, storage, return and destruction of any remaining pharmaceutical products. The investigator should not supply the investigational product to any person not targeted to receive it. Preferably a local pharmacy or the pharmacy department of the local hospital should assume responsibility for storage, delivery, return and keeping records of the investigational and, when appropriate, comparator product(s). If so, these procedures must be documented to make auditing possible.