Drug Evaluation Committee 2019-02 Time to Confirm Investigator's Position on Safety Information
Related classification: Adverse drug reaction reports
Date of first publication: 2019-04
Question
In one sponsor's clinical trial, safety information is issued once every two weeks. At one site, the safety information is provided to the investigator by mail, and the CRA is notified by fax of the investigator's opinion on whether the trial can continue and whether the explanatory document for subjects needs to be revised. In addition, safety information is provided directly by the sponsor to the Clinical Trial Review Committee (external) at this medical institution. 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 meets to review the information.
At this medical institution, there was a case in which the investigator's opinion was confirmed later than the Clinical Trial 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, should the investigator's opinion be notified to the head of the site and the investigational review committee? Also, does the need for notification depend on whether the safety information is sent directly to the investigational review committee or not?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Safety information provided by the sponsor during a clinical trial can be provided simultaneously to the investigator, the head of the 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 GCP for the investigator to record his/her opinion on each safety information and provide it to the Clinical Trial Review Committee.