Drug Evaluation Committee 2013-16 Time to start work as a Clinical Research Assistant Physician
Related classification: clinical trial contracting 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.
GCP Article 43, Paragraph 1, Guidance 1 states "In addition, although it is acceptable for the investigator to start sharing the work of the investigator after receiving approval from the head of the site, a review by the investigational review board (IRB) is required for the investigator sharing the work of the investigator. 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 site for the list of investigators, is it not possible for the investigators to take charge of the actual work to be performed only after approval by IRB review? 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?
Opinion of the Pharmaceutical Cooperative Association
If a clinical 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.