Drug Evaluation Committee 2012-32 Provision of Duplicates and Photocopies of Original Documents to Study Sponsors
Related classification: Obtaining consent
First published: November 2012
Question
In a certain global clinical trial conducted by our company, the clinical trial was completed at all investigational sites in Japan approximately two years ago.
Our overseas representative has informed us that the U.S. FDA has requested that we submit the original photographs (duplicates) of the ophthalmologic 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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, but this does not preclude the head of the implementing medical institution from doing so if he/she thinks it necessary to obtain the opinion of the investigational review committee. in GCP, Therefore, it is considered sufficient if the purpose of submitting ophthalmological examination photographs (duplicates), the destination of submission, storage management of said photographs, and return of said photographs are sufficiently explained in writing, and if the sponsor and the site decide whether a written agreement is necessary 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.