Drug Evaluation Committee 2019-02 Time to Confirm Investigator's Position on Safety Information
Related classification: Report of adverse drug reactions, etc.
Date of first publication: 2019-04
Question
In a sponsor's clinical trial, safety information is issued once every two weeks. At one Investigator Site, the safety information is provided to the investigator by mail, and the CRA is notified by fax of the sponsor's opinion on whether or not the trial can continue and whether or not the explanatory documents for the subjects need to be revised. In addition, at this Investigator Site, safety information is provided directly to the Clinical Trial Review Committee (external) by the sponsor. The Clinical Trial Review Committee meets twice a month, and at the earliest two weeks after the safety information is submitted, the Clinical Trial Review Committee reviews the information.
At this Investigator Site, there was a case in which the investigator's opinion was confirmed later than the Investigator Review Committee meeting. In such a case, when is the deadline for the investigator to record his/her opinion?
- Up to the date of preparation of the Request for Clinical Trial Review
- Up to the date of the clinical trial review committee meeting
- It does not matter if it is after the date of the clinical trial review committee meeting.
Also, under the current GCP, I think it is not necessary to include the investigator's opinion in the request for clinical trial review form. Although it is not required, is the investigator's opinion something that should be notified to the Investigator Site Director and the Investigator Review Committee? Also, does the need for notification depend on whether the safety information is sent directly to the investigational review committee or not?
JPMA's Opinion
Safety information provided by the sponsor during a clinical trial can be provided simultaneously to the investigator, the Chairperson of the Investigator Site, and, if agreed in advance, to the Clinical Trial Review Committee. Therefore, it is possible that the investigator has not yet determined the need to revise the study protocol and/or the explanatory document for subjects at the time when the investigational review committee receives the safety information. Although this is unavoidable due to the process of provision, it is desirable for the investigator to make a judgment and take necessary measures by then, since the Investigational Review Committee will review whether the measures taken for the safety information in question are sufficient from the viewpoint of subject protection.
It is not a procedure stipulated in the GCP that the investigator must record his/her opinion on each safety information and provide it to the Investigator Site or the Investigational Review Committee.