(a) The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s). Where appropriate, the sponsor may supply the investigational product(s) to the trial participants in accordance with applicable regulatory requirements. Investigational product should be supplied after obtaining the required approval/favourable opinion from the IRB/IEC and the regulatory authority(ies) for the trial. Various approaches for shipping and dispensing may be undertaken, for example, by taking into consideration the characteristics of the investigational products, the route and complexity of administration and the level of existing knowledge about the investigational product’s safety profile. Investigational product management should be
arranged and conducted in accordance with applicable regulatory requirements, and safeguards should be in place to ensure product integrity, product use per protocol and participant safety.
(b) The sponsor should ensure that instructions are available for the investigator/institution or trial participants on the handling and storage of investigational product(s). The procedures should consider adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from participants and return of unused investigational product(s) to the sponsor (or alternative disposition if authorised by the sponsor and in compliance with the applicable regulatory requirement(s)).
(c) The sponsor should:
(i) Ensure timely provision of investigational product(s) to the investigator(s) or, where appropriate, to trial participants in accordance with applicable regulatory requirements to avoid any interruption to the trial as well as for the continuation of treatment for participants;
(ii) Maintain records that document the identity, shipment, receipt, return and destruction or alternative disposition of the investigational product(s) (see Appendix C);
(iii) Maintain a process for retrieving investigational products and documenting this retrieval (e.g., for deficient product recall, return and destruction or alternative disposition after trial completion, or expired product reclaim);
(iv) Maintain a process for the disposition of unused investigational product(s) and for the documentation of this disposition;
(v) Take steps to ensure that the investigational product(s) are stable over the period of use and only used within the current shelf life;
(vi) Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications should this become necessary and maintain records of batch sample analyses and characteristics. The samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period. The samples may not need to be kept by the sponsor in trials where an authorised medicinal product is used as an investigational product unmodified from its authorised state in accordance with local regulatory requirements. In this situation, samples are typically kept by the manufacturer.