Drug Evaluation Committee 2009-28 Necessity of Review by Clinical Trial Review Committee in accordance with Change of SMO
Related classification: Clinical Trial Review Committee
First published: Jan 2010
Revised publication date: April 2013
Question
An SMO is changed from Company A to Company B for a clinical trial currently underway. Company A is currently conducting the clinical trial, but due to the resignation of the CRC in charge of Company A, Company A has requested to change the SMO because they do not have enough manpower to conduct the clinical trial.
We have already concluded a basic contract (CRC services) with Company B. The IRB will discuss the deletion of the contract with Company A and the change to Company B. (Until the change to Company B is completed, the CRC services will be provided by the in-house CRC.)
Question 1
Is it acceptable to change the implementation system in the future as described above? We would appreciate it if you could give us specific instructions on how to handle this.
Question 2
In this case, we are considering having both an in-house CRC and an SMO as CRC, and we would like to know if the CRC expenses (in-house expenses and SMO expenses) need to be discussed at the IRB along with the expenses of the clinical trial.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Question 1
The GCP Article 32, Paragraph 1, Section 2, Guidance 5 states that "the investigator review committee shall review the most recent curriculum vitae and other documents to determine whether the investigator is qualified to conduct the clinical trial". However, SMOs and CRC (Clinical Research Collaborators) are not subject to review by the Clinical Trial Review Committee.
Question 2
In GCP Article 32, Paragraph 1, one of the review documents by the Clinical Trial Review Committee is stipulated as GCP Article 10, Paragraph 1, Item 6, "Document explaining the burden of costs of the clinical trial," but this document is not subject to review by the Clinical Trial Review Committee because it is considered as a document regarding payment (if any) to subjects in GCP Article 32, Paragraph 1/2, Guidance 2(1)<6>. However, the same document is defined as a document regarding payment to subjects (if any) in Article 32, Paragraph 1/Section 2 Guidance 2 (1) <6> of the GCP. However, if the Clinical Trial Review Committee deems it necessary as described in GCP Article 32, Paragraph 1/Section 2 Guidance 11, it is subject to review.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical and Food Safety Bureau, No. 1228-7), the explanations in the relevant sections have been changed.