Drug Evaluation Committee (3) How to enter the date consent was obtained on the case report form
Related classification: Obtaining consent
First published: December 2004
Revised publication date: December 2021
Question
In outpatient clinical trials, it is a common occurrence that the date of patient signature on the consent form and the date of receipt and confirmation of the consent form by the physician in charge differ. When listing the "date written consent was obtained" or "date written consent was obtained" on the registration form or CRF, it is sometimes difficult to decide whether to list the date of signature or the date when the consent form was received and confirmed. Which should be listed?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The terms "date of obtaining written consent" or "date of obtaining the subject's written consent" are not defined in GCP and can certainly be taken to mean either "the date the subject signed the consent form" or "the date the investigator received the consent document and confirmed its contents. Especially nowadays, when it is emphasized that subjects (potential subjects) should be given as much time as possible to give their consent to participate in a clinical trial, situations such as the one you are inquiring about are expected to occur more frequently, so it is imperative to eliminate any discrepancy in understanding between the sponsor and the investigators. Since not all sponsors use terms such as "date of obtaining written consent" in the same way, we cannot find a good solution other than to discuss these terms with the sponsor prior to the start of each clinical trial. If terms such as "date of obtaining written consent" are not used, then Article 52, Paragraph 1 of the GCP states, "Consent shall not be effective unless ... a document stating that the subject agrees to participate in the clinical trial (consent document) is dated and signed by the investigator who provided the explanation and the person who is to be the subject, It shall not take effect unless it is dated and signed by the investigator who provided the explanation and the person who is to be the subject. Therefore, for example, it would be one way to have the investigator enter "date of explanation, signature of the person who explained, date of consent, and person who consented" in the column of the consent document, and then provide a column in the registration form (slip) or case report form that is consistent with these entries.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.