Drug Evaluation Committee 2020-42 Consent Process in Medical Records
Related classification: Obtaining consent
Date of first publication: Feb. 2021
Question
After both the patient and the investigator sign the consent document, the physician is required to record the consent process (date and version of the consent document, whether the patient was given enough time to participate in the trial, whether all questions were answered, whether a copy of the consent document was provided to the patient, etc.) in the medical record, etc. However, a principal investigator at one site is refusing to do so. However, one investigator at a certain medical institution is refusing to do so. The reason for this is described in the background below.
Since ICH-GCP and J-GCP do not have a detailed description of the recording of the consent process, we would appreciate your opinion.
Background
The CRA noticed during monitoring that the consent process was not well documented (only a version of the consent document and a record that the consent document was explained) and asked the investigator to document other processes (did he give the patient enough time to participate in the trial, did he answer all questions, did he provide the patient with a copy of the consent document, etc.) in the patient's medical record. The physician refused to do so. The reason being that they believe that the other processes are described in the consent document, so there is no need to describe the same thing in the medical record. Our outsourced CRO QA also informed the investigator as Non-Compliance, but the investigator still refused for the above reason.
Question
Is it unnecessary to record the consent process in the medical record as long as it is described in the consent document?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The GCP Ministerial Ordinance and ICH-GCP do not clearly stipulate to what extent the consent process should be recorded. However, as stipulated in ICH-GCP 2.10, all information must be recorded to enable accurate reporting, interpretation and verification. Therefore, it is not necessary to duplicate the contents of the explanatory and consent documents in the medical record, but it is important to record the contents stipulated in Articles 50-55 of the GCP in a level of detail that can be verified later by a third party. In particular, if the date of consent is the same as the date of screening tests or other tests related to the clinical trial, it is important to clearly indicate that the tests related to the clinical trial were conducted after consent was obtained.
Based on the above, it seems that the sponsor should agree in advance with the investigator before the start of the clinical trial on what kind of content and to what extent records should be created and kept at the site.