Drug Evaluation Committee 2016-18 Form for Reporting Follow-up Information on Serious Adverse Events to the Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
The patient developed MDS (myelodysplastic syndrome) during the administration of the investigational drug, and the administration of the investigational drug was discontinued and the patient is under post-observation. a "Report on Serious Adverse Events" (in the opinion of the investigator, a causal relationship with the investigational drug cannot be denied) regarding MDS was submitted to the hospital IRB. The sponsor's view for the future is that it is not necessary to submit a "Report on Serious Adverse Event", although it is necessary to consistently describe the situation on the SAE form on the EDC.
Is there a GCP issue with entering the SAE on the EDC but not reporting to the IRB on the "Report on Serious Adverse Events" form? Our SOP states that SAE review for the IRB is to be done on the "Report on Serious Adverse Events" form.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in GCP Article 48, Section 2, when a serious adverse event occurs, the investigator must immediately report it to the head of the site and the sponsor. They must also provide any additional information requested by the sponsor, the head of the site, or the Clinical Trial Review Committee. Since the GCP does not stipulate the reporting format for such cases, it would be acceptable to report in the manner stipulated by the sponsor, the site, and the investigational review committee.
In the case of your question, the sponsor has decided to use EDC as a method of obtaining additional information from the investigator, so it is considered that the submission of the "Serious Adverse Event Report" to the sponsor is unnecessary.
On the other hand, we believe that the necessity of reporting additional information to the head of the site and the investigational review committee should be made separately from the sponsor's decision (in this case, the sponsor's decision that the situation must be reported by consistently describing the situation in the EDC). In addition, we believe that it is acceptable for such reporting to be done according to the method established by your hospital.