Drug Evaluation Committee Current Status and Issues of eConsent in Drug Development
Electronic Information Subcommittee
April 2022
eConsent refers to a procedure for providing information to subjects and obtaining their consent using electromagnetic tools such as video and audio. eConsent is of growing interest from the perspective of clinical trials that do not rely on visits to medical institutions (Decentralized Clinical Trial: DCT) and infection prevention under COVID-19 infection spread. Although interest in eConsent is growing from the perspective of Decentralized Clinical Trials (DCT) and infection prevention under the spread of COVID-19 infection, eConsent has not been widely used in clinical trials in Japan.
Therefore, Task Force 3 of the Electronic Clinical Trial Information Subcommittee for FY2020-2021 conducted a questionnaire survey on the spread of eConsent in domestic clinical trials, surveyed service providers handling eConsent in Japan, and summarized the merits and considerations when introducing eConsent, as well as overseas and domestic regulations. The results are summarized in this report.
We hope that this report will promote discussion of eConsent among not only pharmaceutical companies but also other parties involved in clinical trials, promote more patient-centered clinical trials, fully utilize the inherent advantages of eConsent, and help streamline operations and promote the spread of eConsent.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee 2021 Task Force 3
Current Status and Issues of eConsent in Drug Development (1.1MB)
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