Drug Evaluation Committee 2017-02 Record of Confirmation of Source Documents by Clinical Investigators, etc.
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: June 2017
Question
In the preparation of source documents, it may be possible for CRC or other investigational collaborators to include sections that do not involve medical judgment. In that case (when the source documents are prepared by a collaborator), is a record of confirmation (signature, etc.) always required in the source documents to certify that the investigator, etc. has confirmed the contents of the source documents?
In the above case, I believe that many medical institutions are currently conducting confirmation by the investigator. However, I am not sure on what basis this confirmation by the investigator is conducted, so I am asking this question. My personal opinion is that this confirmation is ensured by the investigator's signature on the CRF at the end of the study in accordance with GCP Article 47, Paragraph 1, and that there is no need to check each and every source document prepared by the collaborator. If confirmation by the investigator, etc. is not required, I thought it would reduce the time and effort required by the site.
On the other hand, if this is necessary, we would appreciate it if you could provide a rationale to explain why it is necessary to those medical institutions that are not thorough.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Responsibility for medical care for subjects and medical decisions made on their behalf is assumed by physicians (GCP Article 1 Guidance 2 (7)). In addition, investigators must take necessary measures in advance to ensure that appropriate medical care is provided for adverse events that occur in subjects (GCP Article 45, Paragraph 3).
Therefore, investigators must timely confirm and evaluate all observations and test results that form the basis of medical judgment, including those recorded by collaborators, in order to ensure the safety of subjects. It is also important to record in the source documents that this has been done.
The inclusion of names in the case report form is to ensure the contents of the case report form and the process of preparation and revision, which is different from the above-mentioned confirmation to ensure the safety of the subjects.
Reason for revision of opinion
Minor changes have been made to the description in accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3).