Drug Evaluation Committee 2017-37 Dates to be indicated by subjects, investigators, etc. in the consent document
Related classification: Obtaining consent
Initial release date: December 2017
Revised publication date: March 2021
Question
Please explain how to include this information in the consent document.
It is emphasized that subjects (potential subjects) should be given as much time as possible to give their consent to participate in the clinical trial, but should this process also be made clear in the consent document?
Based on the above, is it sufficient that the date of explanation (by the physician/assistant in charge) and the date of consent (by the subject) should be listed in the date column of the consent document? If so, should the date of explanation be the date when the explanation was first given to the subject, and should there be no record of the confirmation of the subject's consent in the consent document?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 52, Paragraph 1, Guidance 1 states, "The consent document must be signed and dated by the investigator who provided the explanation and the person who is to be the subject or the surrogate subject, respectively, stating that they fully understand the content of the explanation document and agree to participate in the clinical trial. If a cooperating investigator provides supplementary explanations, the cooperating investigator must also sign and date the document. The following is an explanation of the form.
GCP stipulates that the entire process leading up to this signature should be recorded in the consent document. GCP does not require that the entire process leading up to this signature be documented in the consent document.
However, it is important to document that "the subject was given as much time as possible to give his or her consent to participate in the trial. To this end, it is recommended that the process of explaining to the subject and obtaining consent be recorded so that it can be verified from the consent document or medical record.
Reason for revision of opinion
The name and seal were deleted in accordance with the partial revision of the GCP ordinance (December 25, 2020).