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.
Article 43, Paragraph 1, Guidance 1, of the GCP states, "The investigator is allowed to share the duties of the investigator from the point of approval by the Chairperson of the Investigator Site, but the investigator must be reviewed by the Clinical Trial Review Committee. The following is a list of investigators who will be involved in the clinical trial. If the date of IRB review is later than the date of approval by the head of the Investigator Site for the list of investigators, is it not possible for the investigators to actually take charge of the work only after the IRB review approves it? Or, in this case, is it possible to take charge of the assigned work from the date of approval by the head of the Investigator Site and receive post-approval at a later IRB review?
JPMA's opinion
If the investigator wishes to assign a subinvestigator to a part of the important tasks related to the clinical trial, the approval of the Investigator Site Director and IRB approval are required in accordance with Article 43, Paragraph 1, Guidance 1 of the GCP. Therefore, the date of approval by the Investigator Site Director or IRB approval, whichever is later, is the date when the investigator can start work.