Drug Evaluation Committee 2009-03 Communication of Safety Information (Study Report, Action Report, Withdrawal, etc.)
Related classification: clinical trial contracting procedures
First published: Jul. 2009
Question
In accordance with the revision of GCP (Ministry of Health, Labour and Welfare Ordinance No. 24), we intend to use reports prepared by sponsors using the list of Unknown Serious and Accumulated Reports prepared by the Japan Pharmaceutical Manufacturers Association (JPMDA) as IRB materials at our center, What is the reporting method for "Research Report," "Regulatory Action," "Withdrawal of Additional Report," and "Other" from previous years? We believe that they will be treated as aggregate reports, but since there is no item to that effect in the relevant list, please tell us how you will handle them.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Safety information reports from the sponsor to the head of the site and the investigator are conducted based on the method and format agreed upon by the sponsor and site.
For example, using the unified form Form 16 "Report on Safety Information, etc.," it is assumed that the report will be made individually by selecting "Research Report," "Action Report," and "Others" as the applicable items and utilizing the remarks column as necessary.
The common line list for individual reports, which the Pharmaceutical Manufacturers Association of Japan (PMAJ) requests cooperation in using, is created to collect individual case reports (unknown and serious adverse reactions) that the sponsor judges will not affect the continuation of the clinical trial for a certain period of time and provide them to the head of the site and the investigator. It is not intended to be applied to "research reports," "action reports," and "others. In addition, "Withdrawal of additional report" is supposed to refer to the destruction of report (no subject exists, drug is not administered, etc.) or exclusion from report (causal relationship is denied, changed to a known event in the severity category other than death or threat of death, etc.), but since these are not "unknown/serious adverse reactions" in any of these cases, they are not included in the "Individual Report However, since these are not "unknown/serious adverse reactions", they are not included in the common line list.
In addition, the list of Periodic Report Accumulations indicates the name and number of serious adverse reactions and does not include "Research Report," "Regulatory Action," and "Other. Withdrawal of additional reports" will be reflected in the latest occurrence status in the cumulative total column of the periodic report accumulation list (see Q10 of the "Q&A on periodic reports of adverse drug reactions in clinical trials and preparation of summary of clinical trial review committee meeting records," an administrative communication of the Review and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare dated February 5, 2009). (See Q10 of "Q&A on Periodic Reporting of Adverse Reactions to Clinical Trials and Preparation of Summary of Clinical Trial Review Committee Meeting Records"). However, safety information that should be focused on during the investigational unit period will be reflected in the "Opinions and safety measures based on the accumulated evaluation" section of the periodic report.