Drug Evaluation Committee 2008-26 Timing of appointment and contracting of dispatched CRC as a clinical research collaborator (Part 2)
Related classification: Clinical trial contract 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 a dispatched CRC as a clinical trial collaborator. The definition of "investigator" states that it "means ... other medical personnel ... at the Investigator 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 Investigator Site Director approves the implementation of the clinical trial based on the submitted list, requests IRB review, and after approval of the implementation, first appoints a list of collaborators 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.
JPMA's Opinion
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 Investigator Site and the SMO that dispatches the CRC, and we do not believe that this process is 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, the Investigator Site intends to enter into a contract with the SMO in accordance with the opinion of the IRB, and we do not think that this is meant to imply "tacit approval of the list of outsiders.
The definition of "investigator" as stipulated in GCP is considered to refer to an investigator who has been approved by the head of the Investigator 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 Investigator Site, and then approves a specific CRC as a research collaborator and concludes a contract with him/her.
Reason for revision
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Trials on Drugs," the term "a collaborator appointed by the Investigator Site" has been changed to "a collaborator approved by the Investigator Site.