Drug Evaluation Committee 2012-32 Provision of Duplicates and Photocopies of Original Materials to Sponsors of Clinical Trials
Related classification: Obtaining consent
Date of first publication: November 2012
Question
In one of our global studies, the clinical trial was completed about two years ago in Japan at all investigational sites.
Our overseas representative has informed us that the U.S. FDA has requested that we submit a photographic copy of the ophthalmic examination results as stipulated in the protocol for this study. According to the study protocol, the ophthalmologic examination was to be photographed and the findings were to be documented on the CRF by the investigator, but there was no provision for the submission of the photographs (duplicates) to the sponsor. The consent document used in this study stated that the results of this study and other information would be submitted to the regulatory authorities (Ministry of Health, Labor and Welfare, U.S. FDA, etc.).
We would like to submit a written request (statement of reasons) regarding the provision of photographs (reproductions) to the investigational institution and obtain the consent of the said institution. We believe that there is no need for a review by the Clinical Trial Review Committee, the conclusion of a new agreement, or the acquisition of re-consent from the subject. We would appreciate your response if this understanding is correct.
JPMA's Opinion
Whether or not we need to obtain the subject's re-consent in order to submit the ophthalmologic photographs (duplicates) to the regulatory authorities depends on the content of the explanatory document that was used to obtain consent for participation in the clinical trial. The explanatory document for this clinical trial states that the results of this study and other information will be submitted to the regulatory authorities, so the purpose of using the information and data obtained from the subject should be clear. Unless the explanatory document limits the method of collecting ophthalmological test results to methods other than photographs (reproductions), we do not think it is necessary to obtain re-consent from the subject. However, this does not preclude the Chairperson of the implementing medical institution from obtaining the opinion of the Clinical Trial Review Committee if he/she considers it necessary to do so, Therefore, it is considered sufficient if the purpose of submitting ophthalmological examination photographs (duplicates), the destination of submission, storage management of said photographs, return of said photographs, etc. are fully explained in writing, and the sponsor and the implementing medical institution decide whether or not a written agreement is required after discussion.
It is assumed that the ophthalmological examination photographs (reproductions) will be provided to the sponsor with information that can identify the subject (name, medical record number, etc.) masked.