Drug Evaluation Committee 2014-21 Necessity of preserving copies of safety information transmittal letters addressed to Clinical Trial Review Committees
Related classification: clinical trial contracting procedures
First published: October 2014
Question
In the case of a company clinical trial, it may be possible for the sponsor to directly notify the Investigational Review Committee of safety information from overseas that falls under Article 20, Paragraphs 2 and 3 of the GCP, if such information has been agreed upon in advance. In this case, the date of notification from the sponsor to the head of the site and the investigator may differ from the date of notification to the investigational committee.
If the sponsor directly notifies the Investigational Review Committee, it is deemed that the head of the medical institution notifies the Investigational Review Committee.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The purpose of preserving documents related to clinical trial procedures is to ensure that the action has been taken. If the "Report on Safety Information, etc." in your question was submitted by the sponsor to not only the head of the site and the investigator but also 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 investigational review committee is made on a different date from the notification to the head of the site and 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 directly notifies the Investigational Review Committee, it shall be deemed that the head of the medical institution notifies 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.