Drug Evaluation Committee 2011-49 Agreement for Entrustment of Review by a Clinical Trial Review Committee (Part 3)
Related classification: Clinical Trial Review Committee
Date of first publication: Apr. 2012
Question
Question 1
With respect to GCP Article 30, Paragraph 2, Guidance 7, our hospital (B) is entrusted by another medical institution (A) to review a clinical trial review committee. In the contract for entrustment of review, the following sentence is included.
"When the First Party conducts an investigation, the Second Party shall accept and make available to the First Party for direct inspection.
Is it correct to say that as far as GCP guidance is concerned, if we accept the regulatory authority's conformity investigation, and if we are able to provide direct access during the investigation, we do not need to provide the First Party with all of the records related to the Trial Review Committee?
Question 2
In GCP Article 30, Paragraph 2, Guidance 8, there is "audits conducted by the site and investigations by the regulatory authority," but could the site conduct the audits?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
As stipulated in GCP Article 30, Paragraph 2, Guidance 7, during an investigation by the regulatory authority, documents or records stored by your Investigational Review Committee pertaining to the relevant clinical trial are to be made directly available for inspection. In accordance with the agreement between your hospital and the medical institution (Kou), if your hospital accepts the regulatory authority's conformity investigation and makes the necessary documents, records, etc. available for direct inspection during such investigation, "your hospital does not need to provide Kou with all records related to the investigational review committee.
Question 2
Under Article 30, Paragraph 2, Guidance 8 of the GCP, the site is a contractor that entrusts the investigations and deliberations of the Investigational Review Committee, and therefore, the Investigational Review Committee as a contractor can be audited.