Drug Evaluation Committee 2011-36 Preservation of (Copies of) Consent Forms by Medical Institutions
Related classification: Obtaining consent
Initial release date: 2012/04
Revised publication date: March 2021
Question
A clinical investigator at a certain medical institution believes that the subject should have the original consent form and that the medical institution (or medical record) should not have the original consent form. In actual clinical trials, the original consent form is given to the subject and the medical institution keeps only a copy.
Since GCP Article 53 (Delivery of Consent Form) states that "a copy of the consent form shall be delivered to the subject," this is considered a problem under GCP. However, the medical institution seems to think that there is no problem as long as the investigator has his/her own ideas as a principal investigator. The clinical trial review committee has not pointed out any particular problem.
- Why should the medical institution keep the original and the subject the copy?
- Can we consider the above case as a problem under GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When obtaining consent, the investigator must deliver to the subject a copy of the consent document signed or sealed by the investigator and the subject, together with the explanation document (GCP Articles 51 and 53). Furthermore, according to the "Documents and Records Pertaining to Clinical Trials" (a communication from the Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare), "45.1 Consent document with name and seal or signature (including revised version)" must be kept at the site of the study. The original consent document is to be kept at the site of the medical institution conducting the study. The original consent document must be stored appropriately so that it can be presented in case of an investigation by the regulatory authority or an audit by the sponsor's auditor, etc. The clinical trial must be conducted in accordance with GCP.
Clinical trials must be conducted in accordance with GCP. ICH-GCP 4.8.11 also stipulates that subjects should obtain a copy of the consent document rather than the original, as follows
Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written consent form and any other written information provided to the subjects. (The subject or his/her legal representative shall receive a signed and dated copy of the consent document and any other written information provided to the subjects before participating in the clinical trial.)
Therefore, we believe that it is not appropriate for the site to not retain the original documents.
Reason for revision of opinion
The reference document number has been changed in accordance with the revision of "Documents or Records Pertaining to Clinical Trials.