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 an international collaborative study conducted by our company, the clinical trial was completed at all Investigator Sites in Japan approximately two years ago.
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) to the Investigator Site regarding the provision of photographs (reproductions) and obtain the consent of the Investigator Site. We believe that there is no need for the investigational review committee to review the request, enter into a new agreement, or obtain consent from the subject again. 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 Investigator Site from obtaining the opinion of the Clinical Trial Review Committee if he/she considers it necessary to do so, Therefore, the sponsor and Investigator Site may decide whether or not to require a written agreement upon consultation between the sponsor and Investigator Site, after fully explaining in writing the purpose of submitting ophthalmologic examination photographs (duplicates), where the photographs should be submitted, and the storage management and return of said photographs.
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.