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 head of Medical Institution G makes a request for review to Clinical Trial Review Committee F, which is jointly established by the heads of Medical Institutions A to E, through the head 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 shall conclude with the heads of medical institutions A through E, respectively.
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(b) The head of Medical Institution G shall conclude with the heads of Medical Institutions A through E respectively.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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 30, Paragraph 2 of the GCP stipulates that "the head of the site must conclude an agreement in writing with the establisher of the investigational review committee in advance if he/she decides to have a committee other than that established by the entity that owns the site conduct the 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, If the procedure for concluding a contract with all installers is stipulated in the procedure manual of the relevant clinical trial review committee (e.g., contracts with representatives of joint installers, lump-sum contracts with all installers, etc.), there should be no problem in concluding the contract accordingly.