Drug Evaluation Committee 2008-02 Publication of Clinical Trial Review Committee Procedures, etc. using the SMO website
Related classification: Clinical Trial Review Committee
First published: August 2008
Revised: April 2013
Question
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Disclosure of IRB Procedures, etc.
If a medical institution outsources IRB secretariat and clinical trial secretariat services to an SMO under a basic contract with the SMO, do you think that there is no problem if the IRB procedures are disclosed on the SMO's website? (e.g., by placing a link to the SMO's website on the medical institution's website)
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Explanation of Items Discussed by the IRB
According to the revision of the GCP in April 2008, it is desirable that the investigator or sub-investigator (or sponsor's assistant) should explain the items to be discussed at the IRB, but is there any problem if the SMO staff (who are familiar with the study protocol and the investigational new drug summary) can do it on behalf of the investigator? Is this correct?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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(1)
According to Article 28, Paragraph 3, Guidance 3 of the GCP, "It is desirable that the procedures of the investigational review committee be published on the website of the site of the site...". The SMO only provides support to the secretariat of the investigational review committee, etc., and the head of the medical institution or the establisher of the investigational review committee is responsible for preparing and managing the protocols of the investigational review committee, Therefore, we do not think it is desirable to publish them on the SMO's website.
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(2)
Article 29, Paragraph 1, Guidance 4 of the GCP states, "It is appropriate that the explanation of the items to be discussed at the clinical trial review committee should be given by a person who is familiar with the protocol and the investigational new drug summary, etc. Therefore, it is preferable that the investigator (or a subinvestigator if the investigator is unable to attend the meeting) should give the explanation. In addition, it is acceptable for the sponsor to attend the clinical trial review committee meeting and provide supplementary explanations, etc., if necessary". This is based on the idea that a person who is familiar with the contents of the clinical trial and actually conducts the clinical trial is appropriate as a person to explain the contents at the Trial Review Committee. However, if the person who is most familiar with the contents of the clinical trial explains the contents of the clinical trial, the review by the Clinical Trial Review Committee will proceed appropriately and smoothly, it would be preferable to have the investigator, subinvestigator, or sponsor explain the contents of the clinical trial.
Reason for revision of opinion
The provisions to be referred to have been changed in accordance with the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical Affairs Ministry, Food and Drug Administration, No. 1228, Issue No. 7). In addition, the wording of the opinion has been partially changed to more accurately express the purpose of the opinion in response to question 2).