Drug Evaluation Committee 2018-27 Need to view copy of signed consent form (office copy)
Related classification: Other
Date of first publication: September 2018
Question
Our hospital has three copies of the consent form (original: retention, copy: patient copy, and hospital office copy).
Recently, a monitor requested to view the copy of the consent form at your hospital on SDV. I told him that this is not the original document and that the department managing the clinical trial only keeps a photocopy of it to grasp the status of consent obtained from patients, and that it is not for viewing on SDV, but he did not agree. Originally, the copy was not included in the identification of the source documents, and we do not understand why the patient wants to inspect it. I asked for an explanation, but the answer was "because it is a document generated in a clinical trial," which I did not consider to be a basis for such a request.
The hospital has responded that there is no need to present it, but I would appreciate it if you could tell us whether it is necessary (as a mandatory requirement) to present it in the SDV or otherwise, and if so, why.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As part of their monitoring activities, monitors are required to confirm "that free will consent to participate in the clinical trial has been obtained in writing from each subject prior to participation in the clinical trial" (GCP Article 21.1 Guidance 9(5)). This can be confirmed by inspecting the original signed consent document.
On the other hand, the purpose of the monitor's inspection of the consent document office copy may be to confirm whether or not the quality control process for clinical trial operations in the hospital is functioning properly. However, the necessity and frequency of checking the process should be appropriate to the importance (magnitude of risk) of the process.
Please note that monitoring is performed not only on source documents but also on all clinical trial-related records (GCP Article 37, Paragraph 1 / Paragraph 2 Guidance 1).