Drug Evaluation Committee 2013-43 Preservation of Subjects' Logbooks
Related classification: Record keeping
Initial release date: December 2013
Revised publication date: December 2021
Question
In a certain clinical trial (parallel group comparative study), the study protocol stipulates a subject diary in the source documents. The contents written in the subject diary (record of administration of the investigational drug or subject drug, time of use, whether or not the drug was reused, etc.) are transcribed directly into the CRF (paper media) and therefore are considered to be source documents, and according to Article 41-2 of the GCP, the head of the medical institution should appoint a person in charge of keeping the documents at the medical institution.
The sponsor has requested that "The sponsor shall collect and store the original subject logbooks. If necessary, we would like you to keep a copy before collecting it. Other medical institutions have taken such action, and no problems have occurred, and some logbooks have already been collected," was the response. Incidentally, the clinical trial protocol stipulates the following.
"Source documents → subject logbooks (hereinafter omitted), the implementing medical institution shall keep records related to the clinical trial, including source documents (hereinafter omitted), etc., by the person in charge of record keeping designated by the head of the implementing medical institution."
The above is stated above, and there is no indication that the sponsor collects and retains the original subject logbooks. We still think that the source documents, which are the basis of the CRF, should be kept by the site, but is this incorrect?
In Clinical Trial No. 119 , 2007-28, the following opinion is stated regarding the subject's questionnaire regarding quality of life surveys.
If the protocol clearly states in advance that the sponsor and the site will each retain the original and a copy, and if this is agreed upon in advance with the site, then there should be no problem with the sponsor retaining the original."
Compared to the original documents of the subject's questionnaire regarding the QOL survey, the contents of the subject's diary records in this clinical trial are more important, and physicians make clinical decisions based on the administration status of the investigational drug and the subject drug, which I believe is a part of medical treatment. However, as stated above, if the sponsor and investigator agree in advance, is it acceptable for the sponsor to keep the original subject diary?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 2 Guidance 6 defines source documents as follows: "'Source documents' in Paragraph 14 means documents, data and records (e.g., hospital records, medical records, laboratory notes, memos, subject diaries or checklists for evaluation, administration records, recorded data of automatic instruments, copies or transcripts that are certified by verification to be accurate copies, microfiche, photographic negatives, microfilm or magnetic media, radiographs, subject files, and records maintained in the drug department, laboratory, or medical technology department involved in the clinical trial, etc.)." It is stipulated that the term "clinical trial" means a clinical trial. As such, the subject logbook, which is usually the original data for entry in the case report form, is the source document, and the original must be stored at the implementing medical institution.
On the other hand, there are cases where the subject logbook is provided to the site as a record unique to the clinical trial, and the sponsor collects the original logbook instead of posting the data to the case report form. In such cases, if the protocol clearly states in advance that the sponsor will collect the original logbook and that the site will retain a copy of the logbook instead of the original, there should be no problem with the sponsor and site retaining the original and a copy, respectively. In the case in question, the data from the logbook is to be transferred to the case report form, and the protocol clearly states that the original logbook is to be retained by the site. Therefore, you should discuss the necessity of submitting the original logbook with the sponsor, taking into consideration the reasons why the sponsor collects the original logbook and the need to revise the protocol.
If the sponsor collects the original logbook, it is necessary to ensure that the logbook does not contain any information that could identify the subject.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.