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 IRB review is requested outside the hospital, a "Contract of Review of Clinical Trials" must be signed in advance between the IRB establisher and the Investigator Site that is requesting the IRB review. Please tell us what we should keep in mind as IRB establishers regarding the contents of the contract.
What should be specifically stated in the contract regarding "handling of confidential information regarding Investigator Site, sponsor, and subjects," "handling of personal information," etc.? Please also tell us about the following points.
-
1.Compensation to Investigator Site, Sponsor, and Subjects in the Event of Unforeseen Circumstances or Failure on the Part of the IRB Establisher
-
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 investigator site, is there a possibility that the subject or the subject's bereaved family will sue not only the Investigator Site and the sponsor, but also the IRB establishment? (On the responsibility of approving the clinical trial)
If you have a model contract, we would appreciate it if you could provide it to us.
JPMA's Opinion
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 information and personal information, we believe that there should be no problem if the contract stipulates that the information will be stored appropriately, that it will not be leaked to third parties, and that prior approval will be obtained when disclosing the agenda of a clinical trial review committee meeting. For specific terms of the agreement, please discuss with the Investigator Site that is the sponsor of the clinical trial.
It is unclear whether the IRB establisher will be held legally liable, but we believe that the IRB establisher will not be held legally liable if there is no illegal act.
Reason for revision
The quoted part has been changed according to the revision (October 24, 2011) of the "Implementation of the Standards for Clinical Trials of Pharmaceuticals".