Drug Evaluation Committee Current Status and Issues of eConsent in Drug Development
Electronic Standard for Medical Information Expert Committee
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 the spread of COVID-19 infection. 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, in FY2020-2021 Electronic Standard for Medical Information Expert CommitteeTask Force 3 conducted a questionnaire survey on the spread of eConsent in domestic clinical trials, surveyed service providers handling eConsent in Japan, and summarized the benefits and considerations when introducing eConsent, as well as overseas and domestic regulations.
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 use of eConsent.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2021 Task Force 3
Current Status and Issues of eConsent in Drug Development (1.1MB)