Drug Evaluation Committee 2008-26 Timing of appointment and contracting of dispatched CRC as a clinical research collaborator (Part 2)
Related classification: clinical trial contracting procedures
First published: Jan 2009
Revised published: Mar 2012
Question
In question No. 2005-01, there is a question regarding the timing of appointment and contracting of dispatched CRC as a clinical trial collaborator. The definition of "collaborator" states that it is "any other medical personnel at the site....". The investigator has prepared a list of collaborators who are outsiders and submitted an application for conducting a clinical trial under a clinical trial implementation system that includes outsiders. The head of the site approves the implementation of the clinical trial based on the submitted list, requests IRB review, and after approval of the implementation, the investigator first appoints a list including outsiders, followed by a contract with the SMO, and then a clinical trial contract. However, I think that the contract with the SMO should ideally be made before the investigator makes the list, and in the case of tacit approval of an outsider's list, as in the case of this question, it would be logical to make the contract with the SMO after the contract with the SMO.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The previous question (2005-01) quoted in this question expresses the opinion that there is "no particular problem under GCP" with regard to the timing of the contract between the site and the SMO that dispatches the CRC, and we do not consider this process to be mandatory.
In the question in question, we assume that the investigator has listed the name of the CRC belonging to the SMO on the investigator list prior to the contract, but we believe that this is only to clearly state that the potential investigator is dispatched from the SMO. Also, we believe that the implementing medical institution intends to enter into a contract with the SMO in accordance with the opinion of the IRB, and that this does not imply "tacit approval of the list of outsiders".
The definition of investigational collaborator stipulated in GCP is considered to refer to an investigational collaborator who has been approved by the head of the site. Therefore, it seems unlikely that there would be a problem under GCP if the IRB approves the hiring of a CRC as a dispatched worker at the site, and then approves and concludes a contract with a specific CRC as a clinical research collaborator.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Trials on Drugs," the term "investigative collaborator designated by the site" was changed to "investigative collaborator approved by the site.