Drug Evaluation Committee 2018-31 Request for provision of image data after submission of clinical trial end report
Related classification: Obtaining consent
Date first published: December 2018
Question
We received a request from the sponsor to provide image data of the subject after submission of the clinical trial end report. They told us that they could not show non-inferiority to the control drug in this clinical trial and that the purpose was to analyze the chest imaging data for further validation.
Since this is a clinical trial that has already been completed, we decided to respond to the request in a memorandum of understanding as "additional work after the completion of the clinical trial" and to review the request at the Clinical Trial Review Committee. Since the submission of image data was not specified in the study protocol or the subject's explanatory document, the request for the submission of images was to be reviewed by a letter from the sponsor.
In this case, do we have to obtain the subject's consent to submit images? If we need to obtain the subject's consent, should it be in writing or can we just get oral consent from the investigator over the phone, etc.?
JPMA's Opinion
I will answer this question based on the assumption that diagnostic imaging is specified in the study protocol.
The necessity of obtaining the subject's consent to provide imaging data to the sponsor depends on the content of the explanatory document used for the subject in this clinical trial.
Matters to be described in the explanatory document are stipulated in Article 51, Paragraph 1 of the GCP, and item 4, Method of the Clinical Trial, describes what will be done in this clinical trial, including tests, etc., to which subjects will be subjected. On the other hand, GCP does not stipulate in what form the clinical trial data will be provided to the sponsor as an item to be described in the explanatory document.
Therefore, we believe that there is no need to obtain additional consent from subjects for the provision of imaging data, unless there is a statement in the explanatory document of this clinical trial that restricts such provision.
Please also refer to our previous opinion (2012-32).