Drug Evaluation Committee 2014-21 Necessity of preserving copies of safety information transmittal letters addressed to clinical trial review committees
Related classification: Clinical trial contract procedures
Date of first publication: October 2014
Question
In the case of a company clinical trial, if there is a prior agreement on safety information from overseas that falls under Article 20, Paragraphs 2 and 3 of the GCP, the sponsor may directly notify the investigational review committee. In this case, the date of notification from the sponsor to the chief of Investigator Site and investigator and the date of notification to the Clinical Trial Review Committee may differ.
If the sponsor notifies the Investigational Review Committee directly, it is deemed that the Chairperson of the medical institution notified the Investigational Review Committee.
JPMA's Opinion
The purpose of preserving documents related to clinical trial procedures is to ensure that the action has indeed been taken. If the "Report on Safety Information, etc." in your question was submitted by the sponsor to the Investigator Site Director and the investigator as well as to the Clinical Trial Review Committee, it is necessary to be able to explain to a third party when the action was taken. If the notification to the Investigator Site Director and the investigator is made on a different date than the notification to the investigator, it may be a good idea to keep a copy of each notification.
In addition, Article 20, Paragraph 2/3, Guidance 4 of GCP states that "If the sponsor notifies the Investigational Review Committee directly, it shall be deemed that the Chairperson of the medical institution notified the Investigational Review Committee. However, this is an interpretation of the actions of the head of the medical institution and does not refer to the necessity of record keeping by the sponsor.