Drug Evaluation Committee Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)
Clinical Evaluation Subcommittee
April 2024
In order to further promote the electromagnetic handling of clinical trial-related documents, the Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Procedures (2015 edition) were reviewed to adapt them to the current clinical trial procedural environment, and the "Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial-related Documents (2024 edition)" (hereinafter referred to as "SOP, etc."), which assumes the use of a clinical trial cloud system, was published. (hereinafter referred to as "SOPs, etc."), which are based on the use of the clinical trial cloud system.
Regardless of whether you have a procedure or system for electromagnetic handling of clinical trial-related documents, please take this opportunity to review your organization's electromagnetic handling and consider creating or revising your SOPs, etc.
- Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (for medical institutions)
- Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (for medical institutions) Appendix 1
- Clinical Trial Cloud System Checklist
- Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (for sponsors)
Links to symposium materials and video recordings have been added as supplemental information on SOPs, etc. (November 2024)
- On April 20, 2024, a symposium entitled "Promotion and Optimization of the Introduction of Electromagnetic Systems - Don't Miss the boat in the Era of 100% Electromagnetic Systems! was held on the web.
Symposium (held on April 20, 2024) materials and video recording
The 2015 SOPs, explanatory notes (Q&A), and materials from the symposium held in October 2014 will continue to be available as follows. We recommend that you use the SOPs, etc. for the 2024 edition published this time, but please also refer to past SOPs, etc. as necessary. (Please note that the Q&As have not been reviewed this time, so they contain answers that are in line with the situation at the time they were prepared.)
- In December 2024 and February 2025, we surveyed member companies of the Clinical Evaluation Subcommittee on the implementation status of the 2024 version of the electromagnetic SOP template in their SOPs.
- The educational material prepared for CRAs is available to the public. We hope that each company will use this material to promote the use of electromagnetic technology and to communicate with medical institutions.
TP-4_Electromagnetic awareness material for companies and CRAs
In addition, when the stamping of the unified form was omitted according to the March 7, 2012 notice by the Director of the Research and Development Promotion Division and the Director of the Evaluation and Management Division, this report summarizes the Pharmaceutical Evaluation Committee's views on how to ensure the reliability of documents that omit the stamping and on the operation when electromagnetic records are delivered and stored. This opinion was prepared based on the opinions of the regulatory authorities, the Center for the Promotion of Clinical Trials of the Japan Medical Association, medical institutions, the Japan CRO Association, the Japan SMO Association, and other related organizations, as well as the Pharmaceuticals and Food Safety Bureau and the Research and Development Promotion Division of the Medical Affairs Bureau of the Ministry of Health, Labour and Welfare, the Reliability Assurance Department of the Pharmaceuticals and Medical Devices Agency, the Japan Medical Devices Agency, and other related organizations, in addition to the consideration on the part of pharmaceutical companies. The report has been prepared based on the opinions of the regulatory authorities, the Japan Medical Association, medical institutions, Japan CRO Association, Japan SMO Association, and other related organizations. Please refer to this section as necessary. (Names of organizations are as of May 2012)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables