Drug Evaluation Committee 2009-36 Agreement on Commissioning of Review by Clinical Trial Review Committee (Part 1)
Related classification: Clinical Trial Review Committee
First published: Jan. 2010
Revised: Mar. 2012
Question
When an investigational new drug (IRB) review is outsourced, a "contract for outsourcing of investigational review services" must be concluded in advance between the IRB establisher and the sponsor medical institution. Please tell us what we should keep in mind as IRB establishers regarding the contents of the agreement.
What should be specifically stated in the contract regarding "handling of confidential information regarding the site, sponsor, and subjects" and "handling of personal information"? Also, please tell us about the following points.
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1.Compensation to the site, sponsor, and subjects in the event of unforeseen circumstances or fault on the part of the IRB establishment
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2.If a subject suffers a serious disadvantage caused by a clinical trial due to an obvious fault on the part of the sponsor or the site, is there a possibility that not only the site and sponsor but also the IRB establishment could be sued by the subject or his/her bereaved family? (On the responsibility of approving the clinical trial)
If you have a model of the contract, we would appreciate it if you could provide it to us.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We do not have a model contract, but please conclude the contract in accordance with Article 30, Paragraphs 2/4 of the GCP and the guidance in the same article.
Regarding the handling of confidential and personal information, it should be fine if the contract stipulates that the information will be stored appropriately, that it will not be leaked to third parties, and that prior consent will be obtained for the release of the proceedings of the Clinical Trial Review Committee meeting. For specific terms of the agreement, please discuss with the sponsor medical institution.
It is unclear if the IRB establisher is legally liable, but if there is no illegal act, the IRB establisher should not be held legally liable.
Reason for revision of opinion
The quoted part has been changed according to the revision (October 24, 2011) of the "Implementation of the Standards for Clinical Trials of Pharmaceuticals".