Drug Evaluation Committee 2023-53 Revision of the SOP Regarding the Use of eConsent
Related Category: SOP
Initial Publication Date: March 2024
Question
The guidance published by the Ministry of Health, Labor and Welfare on March 30 (“Points to Note Regarding Explanations and Consent Using Electronic Means in Clinical Trials and Post-Marketing Clinical Trials”) explicitly states that “obtaining explanations and consent using electronic means is permissible, provided that explanations and question-and-answer sessions equivalent to those conducted in person take place.”The guidance outlines points that companies and medical institutions conducting clinical trials should note regarding identity verification for remote procedures, authentication of the individual when obtaining electronic signatures, and the provision of explanation and consent documents.We believe that revising the SOP will be necessary when using eConsent at medical institutions.Since the “Standard Operating Procedures for Clinical Trial Procedures Using Electronic Records” (SOPs for clinical trials) at medical institutions currently exclude consent documents from their scope, could you please advise us on what content needs to be updated?
JPMA Opinion
We will base our response on the assumption that the “Standard Operating Procedure for Clinical Trial Procedures Using Electronic Records” refers to the “Standard Operating Procedure for the Digitization of Clinical Trial Procedures (1st Edition: January 8, 2015)” (hereinafter referred to as the 2015 Edition Digitization SOP) prepared by the Japan Pharmaceutical Manufacturers Association.The 2015 Digitalization SOP defines clinical trial-related documents as “documents exchanged between the sponsor, the head of the conducting medical institution, the principal investigator, and the Institutional Review Board (IRB) in accordance with the Ministerial Ordinance on Standards for the Conduct of Clinical Trials of Pharmaceuticals(Ministry of Health and Welfare Ordinance No. 28 of Heisei 9, hereinafter referred to as the “GCP Ordinance”) between the sponsor, the head of the Investigator Site, the principal investigator, and the Institutional Review Board.”Furthermore, the scope of application is specified in “3.2 Clinical Trial-Related Documents Covered by This SOP” as (1) Forms 1–18 and Reference Forms 1–2 prescribed in the “Unified Form Notification,” and (2) materials attached to the unified forms (informed consent and explanatory documents).Therefore, the scope of application includes the process from the sponsor’s provision of information (draft informed consent forms) through the principal investigator’s preparation of the informed consent forms to their submission to the IRB; however, documents requiring signatures (such as signed informed consent forms) are not included within the scope of application.Furthermore, since the 2015 version of the Electronic SOP is primarily designed for procedures involving email and electronic records, we believe updates are necessary from the following perspectives when using eConsent:
① Procedures for handling documents electronically (implementation of a clinical trial cloud system, management framework, training, and accounts)
② Requirements for electronic signature systems; management framework; training; and account management framework
③ Procedures for creation, receipt, delivery, and storage
④ Storage of electronic records (backup and recovery; migration or off-site storage; and disposal)
In addition, we believe that matters not covered by the 2015 Edition of the Electronic SOP (such as the identification of IRB review materials, explanations and consent from patients, provision of documents to patients, and identity verification procedures) must be specified in the relevant SOPs of the medical institution before using eConsent.We recommend that you appropriately update the relevant SOPs and other documents, taking into account the guidance from the Ministry of Health, Labor and Welfare (“Points to Note Regarding Explanation and Consent Using Electronic Methods in Clinical Trials and Post-Marketing Clinical Trials”) as well as consultations with the e-Consent system service provider.