Drug Evaluation Committee JPMA Recommended Form for Communication of Safety Information to Investigator Sites

Clinical Evaluation Subcommittee

April 2022

The JPMA-recommended Form for Communicating Safety Information to Investigator Sites is now available. In addition to the "JPMA Recommended Common Line List for Individual Reporting," which has been used for some time, the "JPMA Recommended Common Summary Table for Individual Reporting," which was newly introduced at the "Information Meeting on the Revised Pharmaceuticals and Medical Devices Act - Impact on Clinical Trials by the Introduction of Investigational Products -" held on February 22, 2022, has been posted. has been posted on our website.。
In accordance with the revised Pharmaceutical Affairs Law, the Notice (*) regarding materials to be submitted immediately prior to the investigation for the new drug GCP onsite survey and written conformity survey has not been revised. As in the past, a list of the progress up to the provision of adverse drug reaction information to Investigator Site is still required, so please take this into consideration when preparing materials for the conformity survey.

(*): Appendix 2, "Procedures for Conducting Documentary Conformity Surveillance and GCP On-site Surveillance for Drug Application Materials, and Conducting Documentary Conformity Surveillance and GPSP On-site Surveillance for Drug Application Materials for Interim Evaluation, Re-Evaluation and Reassessment (NHI No. 0831001, August 31, 2020)", Survey of Applicants and Sponsors (Document 5) Clinical study part 4 (only for medical institutions subject to GCP site survey) (iii) "List of the progression of information on serious adverse drug reactions notified by the sponsor to the Investigator Site under investigation in accordance with GCP Article 20 from the time the information was obtained to the time the information was provided to the Investigator Site under investigation".

Procedures for Conducting Written Compliance Surveillance and GCP On-site Surveillance for Drug Application Materials, and Written Compliance Surveillance and GPSP On-site Surveillance for Drug Application Materials for Interim Evaluation, Re-Evaluation and Re-Evaluation

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