Drug Evaluation Committee 2023-53 Revision of SOPs for the use of eConsent
Related classification：SOP
Initial release date: Mar. 2024
Question
The MHLW guidance (Points to Consider Regarding Explanation and Consent Using Electromagnetic Methods in Clinical Trials and Post-Marketing Clinical Trials) released on March 30 clearly states that "explanation and consent can be obtained using electromagnetic methods on the assumption that explanation and question-and-answer sessions equivalent to face-to-face meetings will be conducted. The points that companies and medical institutions conducting clinical trials should keep in mind regarding the identification of the patient when conducting the trial remotely, authentication of the person when digitally signing, and delivery of the explanation and consent document were presented.We believe that SOPs will need to be revised for the use of eConsent at medical institutions. We would appreciate it if you could tell us what should be updated in the "Standard Operating Procedures for Clinical Trials Procedures by Electromagnetic Records" of SOPs (Standard Operating Procedures for Clinical Trials) at medical institutions, as the consent document is not applicable to them.
Opinion of the Pharmaceutical Association of Japan
We assume that the "Standard Operating Procedures for Clinical Trials Using Electromagnetic Records" is intended to be the "Standard Operating Procedures for Electromagnetic Clinical Procedures (1st edition: January 8, 2015)" (hereinafter referred to as the "2015 Electromagnetic SOP") prepared by the Japan Pharmaceutical Manufacturers Association (JPMA).The 2015 electromagnetic SOP defines clinical trial-related documents as "documents delivered and received between the sponsor, the head of the medical institution, the principal investigator, and the clinical trial review committee in accordance with the Ministerial Ordinance Concerning Standards for the Conduct of Clinical Trials of Pharmaceuticals (Ministerial Ordinance No. 28 of the Ministry of Health and Welfare, 1997, hereinafter "GCP Ordinance"). In addition, the scope of application is defined as (1) Forms 1 to 18 and Reference Forms 1 to 2 stipulated in the "Uniform Form Notification" and (2) materials attached to the Uniform Forms (consent and explanation documents) in "3.2 Clinical Trial Documents to Which This Manual is Applicable". Therefore, the scope of application includes the provision of information (draft explanation and consent document) by the sponsor, preparation of the explanation and consent document by the investigator, and submission of the explanation and consent document to the IRB, but does not include documents that require signatures, etc. (signed consent forms). In addition, since the 2015 Electromagnetic SOP is a procedure that mainly assumes e-mail/electromagnetic records, we believe that the following aspects will need to be updated when using eConsent.
(i) Procedures for handling documents electromagnetically (introduction of clinical trial cloud system, management system, education, accounts)
(ii) Requirements, management system, education, and account management system for electronic signature system
(iii) Procedures for creation, receipt, delivery, and storage
(iv) Storage of electromagnetic records (backup and recovery, migration or evacuation, and destruction)
Other contents not included in the indications of the 2015 Electromagnetic SOP (e.g., identification of IRB discussion materials, explanation and consent to patients, delivery to patients, identification procedures, etc.) should be separately specified in the applicable SOP of the medical institution and then eConsent should be used. It is recommended that the relevant SOPs, etc. be appropriately updated based on the MHLW's guidance (Points to Consider Regarding Explanation and Consent Using Electromagnetic Methods in Clinical Trials and Post-Marketing Clinical Trials) and consultation with e-Consent system service providers.