Drug Evaluation Committee 2007-25 Digitization of Clinical Trial Review Committee Review Materials
Related classification: Clinical Trial Review Committee
Date of first publication: August 2008
Question
Is it possible to digitize IRB materials? In other words, is it correct to assume that IRB deliberations by digitizing the materials will have the same effect as the current ones conducted in paper form?
We are planning to digitize the IRB materials and provide each committee member and external committee members with a PC on the day of the IRB so that they can view the materials on the PC while deliberating.
As you know, paper-based IRB deliberations are very labor-intensive in terms of preparation before IRB and processing of deliberation materials after IRB, and the Clinical Trial Management Office is considering this idea to activate IRB, improve IRB efficiency, and reduce the burden of overwork on those involved in the clinical trial administration office.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 10, Paragraph 2 of the GCP stipulates that instead of submitting in writing the documents that must be submitted to the head of the implementing medical institution when requesting a clinical trial (the documents in each item of Article 10, Paragraph 1 of the GCP), the items to be included in each document may be submitted by electromagnetic methods with the consent of the head of the implementing medical institution, as stipulated in Article 10, Paragraph 4 of the GCP. The MHLW ordinance also stipulates that the information to be included in each item of the document may be submitted by an electromagnetic method with the consent of the head of the medical institution concerned. In addition, Ordinance No. 44 of the Ministry of Health, Labour and Welfare (March 25, 2005) stipulates that review materials of the investigational review board (hereinafter referred to as "IRB") can be stored in electromagnetic records instead of in written form. However, when electromagnetic records are submitted, viewed, and stored instead of written documents, the authenticity, legibility, and preservation of such electromagnetic records must be ensured.
In addition, Article 32 of GCP (Responsibilities of IRBs) states that IRBs shall review whether the clinical trial under review is ethically and scientifically appropriate and whether the clinical trial is appropriate to be conducted at the relevant medical institution. In the case you are inquiring about, the key point is whether the IRB member is able to conduct the review appropriately. In other words, if the IRB members cannot examine the documents sufficiently in advance, there should be no problem in changing from written documents to electromagnetic records.
Furthermore, since the document submitted in writing is the original, more attention should be paid to the fact that the electromagnetic record distributed to the IRB members is consistent with the original. We also ask that you ensure security when distributing the electromagnetic records to the IRB members.