E6: Communication with IRB/IEC

Question 1

4.4 - Communication with IRB/IEC

4.4.1

Answer 1

Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.

Question 2

Communication with IRB/IEC

4.4.2

Answer 2

As part of the investigator’s/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator’s Brochure. If the Investigator’s Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator’s Brochure to the IRB/IEC.

Question 3

Communication with IRB/IEC

4.4.3

Answer 3

During the trial the investigator/institution should provide to the IRB/IEC all documents subject to review.