ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

(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; Maintain records that document the identity, shipment, receipt, return and destruction or alternative disposition of the investigational product(s) (see Appendix C); 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);

(ii)

(iii)

(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.

3.16

Data and Records

3.16.1

Data Handling

(a) The sponsor should ensure the integrity and confidentiality of data generated and managed.

(b) The sponsor should apply quality control to the relevant stages of data handling to ensure that the data are of sufficient quality to generate reliable results. The sponsor should focus their quality assurance and quality control activities, including data review, on data of higher criticality and relevant metadata. (c) The sponsor should pre-specify data to be collected and the method of its collection in the protocol (see Appendix B). Where necessary, additional details, including a data flow diagram, should be contained in a protocol related document (e.g., a data management plan).

39