Drug Evaluation Committee 2012-29 Digitization of Clinical Trial Review Committee Review Documents (Part 2)
Related classification: Clinical Trial Review Committee
First published: October 2012
Question
I would like to ask you about the computerization of investigational new drug review committee (IRB) review documents.
At this time, our hospital is considering using tablet terminals for deliberations with an external server. The electronic documents are stored on an external server via the facility terminal, and each tablet terminal downloads the electronic documents from the server using a dedicated application. In this case, the electronic documents are encrypted PDF files that cannot be opened without the dedicated application.
Currently, paper review materials are mailed to external committee members in advance of the IRB review. When the review materials are converted to electronic format, a tablet device will be mailed. The risk of loss is the same for paper, but there is concern about the loss of the device itself.
In this regard, can you tell us JPMA's opinion on whether the loss of the device itself would be handled in the same way as paper in terms of the loss of the sponsor's development information, etc. to outside parties, or what would happen if the device were actually lost?
JPMA's Opinion
As stated in the "Five-Year Plan for the Revitalization of Clinical Research and Clinical Trials 2012" issued by MEXT and MHLW on March 30, 2012, MEXT and MHLW are promoting the computerization of IRB review documents in order to improve efficiency and reduce the burden of clinical trial operations and clinical trial costs. Japan Pharmaceutical Manufacturers Association (JMA) fully supports this initiative, but at the same time, we would like to ask medical institutions and clinical trial review committees to keep in mind the need to protect confidential information (which may include personal information) related to the product under development that belongs to the sponsor. We would like to ask for your continued attention to the following.
Possible measures in the event of loss of a tablet device include moving or deleting files on the server and restricting access (communication) from the lost device, etc. We would like you to take all possible measures according to the system. In addition, it may be necessary to immediately contact the sponsor of the clinical trial from which the information originated.
These measures will not be effective if a terminal with the files already installed is lost, so it is necessary to ensure the security of both the terminal itself and the electronic files (password protection, etc.) and to take thorough measures to prevent the loss or theft of the terminal in advance. Therefore, it is necessary to secure both the terminal itself and electronic files in advance (password protection, etc.) and take thorough measures to prevent loss or theft of the terminal.