E6: Confirmation of Review by IRB/IEC

Question 1

Confirmation of Review by IRB/IEC

5.11.1

Answer 1

The sponsor should obtain from the investigator/institution:
(a) The name and address of the investigator’s/institution’s IRB/IEC.
(b) A statement obtained from the IRB/IEC that it is organized and operates according to GCP and the applicable laws and regulations.
(c) Documented IRB/IEC approval/favourable opinion and, if requested by the sponsor, a current copy of protocol, written informed consent form(s) and any other written information to be provided to subjects, subject recruiting procedures, and documents related to payments and compensation available to the subjects, and any other documents that the IRB/IEC may have requested.

Question 2

Confirmation of Review by IRB/IEC

5.11.2

Answer 2

If the IRB/IEC conditions its approval/favourable opinion upon change(s) in any aspect of the trial, such as modification(s) of the protocol, written informed consent form and any other written information to be provided to subjects, and/or other procedures, the sponsor should obtain from the investigator/institution a copy of the modification(s) made and the date approval/favourable opinion was given by the IRB/IEC.

Question 3

Confirmation of Review by IRB/IEC

5.11.3

Answer 3

The sponsor should obtain from the investigator/institution documentation and dates of any IRB/IEC reapprovals/re-evaluations with favourable opinion, and of any withdrawals or suspensions of approval/favourable opinion.