Drug Evaluation Committee 2010-42 Implementation of SMO Services by NPOs Establishing Clinical Trial Review Committees
Related classification: Clinical Trial Review Committee
First published: January 2011
Revised publication date: December 2021
Question
I have a question regarding GCP Article 27.
We are a non-profit organization (NPO), and we established a Central Clinical Trial Review Committee in October 2010.
At the end of Article 27, Paragraph 2, of the GCP Operation Notice, there is an excerpt from the GCP Ministerial Ordinance and the GCP Operation Notice (Pharmaceutical and Food Safety Bureau, No. 0921001, September 21, 2006) prior to the revision (April 1, 2008), which includes the following provisions.
(9) The establishment of a clinical trial review committee is not involved in the development of drugs for clinical trials that are the subject of investigation and deliberation as its business. In this case, "development of a drug pertaining to a clinical trial that is the subject of investigation and deliberation" includes the advertising business of the said clinical trial, the business of a clinical trial site support organization, etc.
Is this an explanation of Article 27 before the amendment, or does it mean that it does not have to be taken into account in the current Article 27? If it is not necessary to take it into consideration, it means that the establisher of a clinical trial review committee (our company) can provide support services related to a clinical trial for a clinical trial site.
Could you please tell me whether or not support services are possible?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The clause in your question, Article 27, Paragraph 2, Guidance 5(9) of the GCP, "As a business conducted by the establisher of a clinical trial review committee, ..." is still in effect. The section in your question, "<Reference> GCP Ministerial Ordinance before amendment (excerpt)," is a reference to Article 27, Paragraph 2, Guidance 5 (1) of the GCP.
Therefore, we believe that it is problematic for your company, as an establisher of a Clinical Trial Review Committee, to provide support services to the investigational sites with regard to the clinical trial discussed by the said Clinical Trial Review Committee.
Reason for revision of opinion
We have reviewed the opinion and made some changes.