E6: Supplying and Handling Investigational Product(s)

Question 1

5.14 - Supplying and Handling Investigational Product(s)

5.14.1

Answer 1

The sponsor is responsible for supplying the investigator(s)/institution(s) with the investigational product(s).

Question 2

Supplying and Handling Investigational Product(s)

5.14.2

Answer 2

The sponsor should not supply an investigator/institution with the investigational product(s) until the sponsor obtains all required documentation (e.g., approval/favourable opinion from IRB/IEC and regulatory authority(ies)).

Question 3

Supplying and Handling Investigational Product(s)

5.14.3

Answer 3

The sponsor should ensure that written procedures include instructions that the investigator/institution should follow for the handling and storage of investigational product(s) for the trial and documentation thereof. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product(s) to the sponsor (or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement(s)).

Question 4

Supplying and Handling Investigational Product(s)

5.14.4

Answer 4

The sponsor should:

(a) Ensure timely delivery of investigational product(s) to the investigator(s).
(b) Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s) (see 8. Essential Documents for the Conduct of a Clinical Trial).
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(c) Maintain a system for retrieving investigational products and documenting this retrieval (e.g., for deficient product recall, reclaim after trial completion, expired product reclaim).
(d) Maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.

Question 5

Supplying and Handling Investigational Product(s)

5.14.5

Answer 5

The sponsor should:

(a) Take steps to ensure that the investigational product(s) are stable over the period of use.
(b) 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. To the extent stability permits, 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.