Drug Evaluation Committee 2009-33 Image storage media to be provided to the sponsor
Related classification: Record keeping
Initial release date: January 2010
Revised publication date: March 2021
Question
Until now, our hospital has mainly made copies of images on film and some on CD-Rs. This time, we were told by the sponsor that what we can provide is CD-RW and that other facilities are also requesting CD-RW.
Our hospital believes that CD-RW is problematic because the data cannot be modified by a third party, as information cannot be added or modified on a CD-R. However, as other sites are also conducting the study, we are not sure if this is a problem with CD-RW or not. However, if CD-RW is the norm, as is the case at other institutions, we will not be able to prepare in time unless we decide that CD-RW is acceptable, especially since we cannot hope for flexible and speedy responses in international collaborative trials.
Is the sponsor's policy of proceeding with CD-RW really correct? I would appreciate it if you could tell me. The response is neither flexible nor speedy, even though international clinical trials demand speed. Thank you in advance.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As defined in GCP Article 2, Section 14, source documents are "data and other records obtained from the administration of the investigational drug or post-marketing clinical trial product to the subject and from medical treatment", so the image data stored at the site are source documents. Therefore, the image data stored at the site is considered to be source documents, and those provided to the sponsor are considered to be copies of the source documents. In addition, Article 21, Paragraph 1, Guidance 1 of the GCP stipulates that "monitoring shall be conducted to confirm that clinical trial data, etc. are accurate and complete and can be verified in light of the source documents and other clinical trial-related records. Therefore, even if additions or corrections are made to the provided copy, it is considered to be the responsibility of the sponsor.
If you have any other questions, such as why CD-RW is specified instead of CD-R, please contact the sponsor.
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.