Drug Evaluation Committee 2016-02 Application of the Japanese ER/ES Guideline to Clinical Trials
Related classification: Other
Date of first publication: June 2016
Question
In response to public comments on the Japanese version of the ER/ES Guidelines (Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, April 1, 2005, Pharmaceutical and Food Safety Bureau Director-General Notification No. 0401022, "Use of Electromagnetic Records and Electronic Signatures in Applications for Approval or License, etc. of Pharmaceuticals, etc."), the following questions and the MHLW's thinking on them were answered The following questions and the Ministry of Health, Labour and Welfare's position on them were answered in response to the public comments.
Q&A No. 185 Scope of Application
- Q
- Are electronic data (electronic medical records, clinical laboratory data, etc.) of the medical institution that conducted the clinical trial covered by this guideline?
- A
- Materials created for a clinical trial (e.g., contracts, investigational new drug registry) are covered, but materials created as a medical practice (e.g., electronic medical records) are not covered by this guideline.
Our hospital conducts clinical pharmacology studies on healthy adults. Although we basically use paper medical records for clinical pharmacology studies, some data, such as clinical tests and radiographs, are reported in electronic medical records. However, a sponsor pointed out to us that the test results reported in the electronic medical record should be used as the source documents. Since the subjects are healthy people, data for clinical trials, not for medical purposes, will be reported in the electronic medical record. Please tell us the Pharmaceutical Manufacturers Association of Japan's view on whether data from clinical pharmacology studies are subject to the ER/ES guidelines.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The Japanese version of the ER/ES guidelines covers materials and source documents prepared for the application for approval of pharmaceutical products, etc., and defines the requirements for the use of electromagnetic records and electronic signatures for these materials.
On the other hand, electronic medical records are not subject to the Japanese ER/ES Guidelines because they are systems developed for general medical treatment and are not originally intended for the preparation of documents related to applications for approval of pharmaceutical products.
However, the use of this system is not subject to the Japanese ER/ES guidelines, as it is based on the "About the Storage of Medical Records in Electronic Media" (April 22, 1999, Ministry of Health and Welfare, Director-General of Health Policy Bureau, Director-General of Drug Safety Bureau, and Director-General of Insurance Bureau), "About Places to Store Medical Records" (March 29, 2002, Ministry of Health, Labor and Welfare, Director-General of Medical Policy Bureau and Director-General of Insurance Bureau) and these notifications. The "Guidelines for the Safe Management of Medical Information Systems" (hereinafter referred to as the "Guidelines"), etc., prepared in accordance with the "Guidelines for the Safe Management of Medical Information Systems" (hereinafter referred to as the "Guidelines") must be complied with.
These Guidelines, like the Japanese ER/ES Guidelines, stipulate the requirements of authenticity, readability, and retention when treating electronic medical records as electromagnetic records, and we believe that the Japanese ER/ES Guidelines will be complied with by following these Guidelines even when electronic medical records are used for clinical trials and these records are used as source documents. We believe that the Japanese version of the ER/ES Guideline will be complied with by following these Guidelines.