Drug Evaluation Committee Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)
Clinical Evaluation Subcommittee
Updated April 2026
For the purpose of further spreading the electromagnetic handling of clinical trial-related documents, the 2015 edition of the "Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Procedures" was revised to adapt to the current clinical trial procedural environment, and the "Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial-related Documents ( The "Standard Operating Procedures, etc. for Electromagnetic Handling of Clinical Trial Documents (2024 Edition)" (hereinafter referred to as the "2024 Edition SOP, etc.") was issued in April 2024.
Regardless of whether you have a procedure or system for electromagnetic handling of clinical trial-related documents, please review your organization's electromagnetic handling and use this information to create or revise 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)
The following materials will also help to further promote the use of electromagnetic handling for sponsors and medical institutions that are considering the introduction of electromagnetic handling or have already introduced it, but are still facing problems. We hope you will find it useful.
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| Documents | Subject | Overview |
|---|---|---|
| Examples of Cloud System Introduction at Medical Institutions
-Toward the Promotion of Electromagnetic Conversion of Clinical Trial Documents- (Published in April 2026) |
Medical institution
Clinical trial sponsor |
We surveyed medical institutions that have already introduced cloud systems and compiled a collection of case studies. Please use this information to promote the use of electromagnetic technology at your medical institution. |
| TP-4_Questionnaire for member companies of the Clinical Evaluation Committee on the status of introduction of electromagnetic systems (April 2025) | Sponsor. | In December 2024 and February 2025, we surveyed member companies of the Clinical Evaluation Committee on the status of implementation of the 2024 version of the electromagnetic SOP template in their SOPs. |
| TP-4_Electromagnetic awareness materials for companies & CRAs (April 2025) | Sponsor. | This is an educational material on electromagnetic SOPs created for CRAs. We hope that each company will make use of this material for the promotion of electromagnetic SOPs and for communication with medical institutions. |
| Symposium materials and video recordings (held in April 2024) | Medical institution
Clinical trial sponsor |
The symposium "Promotion and Optimization of Electromagnetic Adoption: Don't Miss the Era of 100% Electromagnetic Adoption! The presentation materials and lecture videos of the symposium are available here. |
| Clinical Trial Sponsor
Medical institutions |
The following are the 2015 SOPs, Explanation (Q&A), and materials from the symposium held in October 2014. (Please note that the Q&As have not been reviewed, so the answers are based on the situation at the time of preparation.) | |
| Drug Evaluation Committee's Position on the Uniform Forms Two Chiefs' Notification (Published in May 2012) | Clinical Trial Sponsor
Medical institutions |
The following is a summary of the Drug Evaluation Committee's views on how to ensure the reliability of documents that omit the seal and the operation of delivering and storing electromagnetic records when the seal is omitted in accordance with the March 7, 2012 notification by the two division directors, the Director of the R&D Promotion Division and the Director of the Evaluation Management Division. 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 following is a summary of the report. Please refer to it as necessary. (Names of organizations are as of May 2012) |