Drug Evaluation Committee 2013-16 Time to start work as a Clinical Research Assistant Physician
Related classification: Clinical trial contract procedures
First published: August 2013
Question
We would like to inquire about the review by the Investigational Review Board (hereinafter referred to as "IRB") at the time of change of investigators.
In GCP Article 43, Paragraph 1, Guidance 1, it is stated that "Although it is acceptable to assign a physician to a clinical trial from the time of approval by the Chairperson of the site, a review by the Investigational Review Board (IRB) is required for a physician to be assigned to a clinical trial. However, the clinical trial review committee must review the work of the investigators who are to be assigned to the clinical trial. If the date of IRB review is later than the date of approval by the head of the site for the list of subinvestigators, is it not possible to actually be in charge of the work of subinvestigators until after IRB review and approval? Or, in this case, is it possible to take charge of the assigned work from the date of approval by the head of the site and receive post-approval at a later IRB review?
JPMA's opinion
If the investigator assigns a subinvestigator to take charge of a part of important tasks related to the clinical trial, the approval of the head of the site and IRB approval are required in accordance with Article 43, Paragraph 1, Guidance 1 of the GCP. Therefore, the date of approval by the head of the site or the date of IRB approval, whichever is later, is the date when the investigator can start work.