Drug Evaluation Committee 2015-02 Clinical Trial Agreement when a CRO is involved (Part 2)
Related classification: clinical trial contracting procedures
First published: July 2015
Question
I would like to inquire about modifying the "sponsor" section in the clinical trial request form after approval by the investigational new drug review board (hereafter referred to as IRB).
This is a clinical trial with a CRO, and the IRB has already approved it. I believe that under GCP, if the sponsor, CRO, and site agree, it is possible to have a two-party contract between the CRO and site. However, our hospital does not have a two-party contract with CROs, except for domestic managers of clinical trials.
This time, the CRO side thought that the medical institution had agreed to a two-party contract with the CRO, and a clinical trial request form and other documents were prepared in the CRO's name and approved by the IRB (it is unclear who the agreement was made with. (It is unclear to whom the agreement was made. No emails or other documents were left behind.) The implementing medical institution thought that the CRO was the domestic caretaker and accepted the clinical trial request form with the CRO listed as the sponsor. When we contacted the CRO for confirmation at the contract stage, we were told that the CRO is a development contractor and not a domestic caretaker (the clinical trial notification was submitted by the sponsor located in Japan).
In such a case, we are struggling with how we should respond, such as whether we should ask the IRB to submit the application again from the beginning as a new clinical trial, or whether we should submit a change application by expedited review, etc., saying that the sponsor of the clinical trial has been changed in the request form. This kind of thing is not in the procedure manual, and I feel it is difficult to know how to use the unified form.... What do you think? Our SOP states that "correction of errors in review documents except for explanatory documents to subjects" can be handled by a change report. I am thinking that it may be possible to have a corrected version of the form made on the change report form.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The original responsibility of a clinical trial review committee is to review whether the clinical trial under review is ethically and scientifically appropriate and whether it is appropriate to be conducted at the relevant medical institution (GCP Article 32, Paragraph 1). Therefore, if the investigational review committee has appropriately reviewed whether the clinical trial can be conducted or not, there is no need to conduct another review or expedited review regarding the change of the sponsor's name.
We believe that it is acceptable to record the circumstances of the misunderstanding between your hospital and the CRO, as described in your question, and to conclude a three-way agreement between your hospital, the sponsor, and the CRO. In order to avoid misunderstandings in clinical trial procedures, it would be desirable to include the CRO's contractor, the sponsor, in the appropriate section of future procedural documents, rather than the CRO.