Drug Evaluation Committee 2011-05 Agreement on Commissioning of Review by Clinical Trial Review Committee (Part 3)
Related classification: Clinical Trial Review Committee
First published: Jul. 2011
Question
Please tell us about the contract for requesting a review by a Clinical Trial Review Committee.
When the Chairperson of Medical Institution G makes a request for review to the Clinical Trial Review Committee F, which is jointly established by the Chairpersons of Medical Institutions A to E, through the Chairperson of Medical Institution A, how should the contract be concluded? I know that the options are a to c below, but which one is more common and correct under GCP?
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(A)The head of medical institution G concludes with the heads of medical institutions A through E, respectively.
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(b)The head of medical institution G concludes a single contract with the heads of medical institutions A through E.
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(c)The head of medical institution G concludes an agreement only with the head of medical institution A who requested the review.
JPMA's Opinion
Article 30, Paragraph 2 of the GCP stipulates that "the Chairperson of an Investigator Site must conclude an agreement in writing with the establisher of the investigational review committee in advance when he/she decides to have a committee other than the one established by the corporation that owns the Investigator Site conduct investigations and deliberations. If the procedure manual of the committee stipulates specific procedures for concluding an agreement (e.g., agreement with the representative of the co-investigators, collective agreement with all the co-investigators, etc.), the committee should conclude an agreement with all the co-investigators in advance in writing, We believe that there is no problem in concluding the agreement accordingly.。