Drug Evaluation Committee Survey Report on the Status of Utilization of Safety Information for Clinical Trials
Clinical Evaluation Subcommittee
June 2020
The sponsor is required to collect and review information necessary for the proper conduct of clinical trials, including matters related to the quality, efficacy, and safety of the study drug, and to provide this information to the investigational medical institution, investigator, and clinical trial review committee (GCP Article 20). In 2009, the Pharmaceutical Manufacturers Association of Japan (PMAJ) proposed the Common Line List Form for Individual Reporting as a form to be used for providing information on adverse drug reactions during clinical trials. About 10 years have passed since then, and the clinical trial environment in Japan has changed dramatically with the increase of international clinical trials and the introduction of IT systems.
In light of such changes in the environment, the committee for promotion of clinical research of the Japanese Society of Hospital Pharmacists and the team for continuing issues of the Clinical Evaluation Subcommittee of the Pharmaceutical Evaluation Committee jointly conducted a survey on the current status of information utilization and review at medical institutions that receive safety information during clinical trials. The survey includes the utilization of the common line list for individual reports.
We hope that the results of the survey will be helpful to companies in providing safety information.
Report on the Results of the Questionnaire Survey for Medical Institutions_Final Version (981KB)
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