Drug Evaluation Committee 2005-01 Time of appointment and contracting of dispatched CRC as a clinical research collaborator (Part 1)
Related classification: clinical trial contracting procedures
First published: May 2006
Revised: Mar. 2012
Question
We are currently considering the introduction of dispatched CRC from two SMOs.
One company requires us to sign a basic contract for outsourcing and confidentiality in advance, while the other company says that we can sign a contract after the implementation of each clinical trial has been decided.
We believe that various forms of contracts are acceptable, but I would like to ask you a question regarding the nomination of investigational collaborators.
At our hospital, we nominate investigators based on the list submitted by the investigator in advance, and the Director's decision on instructions is made after the Investigational Review Board (IRB) review.
If we are to introduce a CRC dispatched from an SMO that does not have a basic contract, would there be a problem if the IRB also reviews the dispatch of the CRC, and then after the Director's decision (nomination), we proceed with the contracting process with the SMO at the same time as the contract for the implementation of the clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The IRB at your hospital is required to deliberate on the dispatch of CRC (appropriateness of accepting the dispatched CRC, eligibility of the SMO dispatching the CRC, eligibility of the dispatched CRC, etc.), but this item is not a required deliberation under the GCP. However, if your hospital considers this matter to be a matter for deliberation, there should be no problem if your hospital and the SMO conclude a contract for such services as stipulated in Article 39-2 of the GCP (outsourcing of services, etc.) after obtaining IRB approval and the approval of the Director, and conclude a clinical trial implementation agreement at the same time.
Reason for revision of opinion
In accordance with the revision (October 24, 2011) of the "Implementation of Standards for Clinical Trials on Drugs," "approval by the Director" has been changed to "approval by the Director.