Drug Evaluation Committee Where to report supplemental information not directly related to 2015-47 SAE
Related classification: Adverse drug reaction reports
Date of first publication: 04/2016
Question
Background
In a certain clinical trial, we are required to report on the SAE report form prescribed by the sponsor (hereinafter referred to as "sponsor's form"). This institution has introduced a uniform form, and the sponsor has requested the following.
- Reporting to the head of the site/Investigational Review Committee should be done in accordance with the site's regulations.
- Although the sponsor is not required to submit a uniform report form, the information should be consistent with the information on the sponsor's form.
One day, we received a request from the sponsor to "Please submit an additional SAE report on the subject's subsequent progress, even though it is not related to the relevant event. The content of the report was that "the subject decided to transfer to another facility upon completion of the trial" and "the subject died due to exacerbation of the underlying disease" which were judged to be unrelated to the relevant event. There is absolutely no change/change in the information regarding the relevant event.
In response to the above, we confirmed the views of the implementing medical institution as follows
Principal investigator: No report to the hospital director because it is not related to the relevant event (report in the investigator's form is in response to the request of the investigator).
Clinical trial office: Not specified in the SOP and left to the discretion of the investigator and sponsor
In this case, it was decided to report only on the sponsor's form, and not to report to the site and deliberate at the Clinical Trial Review Committee.
Question
If we have to report the progress of a subject unrelated to the event on the sponsor's form, should we also report it to the head of the site in terms of GCP? Is it always necessary to report to both parties (the sponsor and the head of the site) at the same time? If it is a report of supplementary information unrelated to the relevant event, is it acceptable to report it only to the sponsor?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As GCP Article 48, Paragraph 2 and Paragraph 3, Guidance 5, "The investigator must submit additional information (autopsy report, terminal medical record, and other necessary information) requested by the sponsor, the head of the site, and the investigational review committee, etc., regarding the reported serious adverse event or side effect, including death cases, to these parties. . shall be submitted to them." The SOPs of your hospital and the relevant clinical trial are as follows.
There are no provisions in your hospital's SOP and the relevant study protocol, or instructions from the head of the site to submit additional information in response to the serious adverse event, and furthermore, the investigator has fully considered the relationship between the event and the additional information requested by the sponsor, and has determined that there is no need to provide the head of the site with the additional information requested by the sponsor. If the investigator has determined that there is no need to provide the additional information to the head of the site, then there is no problem in providing the additional information only to the sponsor.