Drug Evaluation Committee 2011-37 Order of Clinical Trial Request Form and Contract Review Agreement
Related classification: Clinical Trial Review Committee
Date of first publication: Apr. 2012
Question
We are the secretariat of a clinical trial review committee that receives requests for review from external medical institutions. We received a request from a medical institution that entrusts the review of a certain clinical trial to our committee (hereinafter referred to as "the other medical institution") that they would like to hurry up to conclude a contract review agreement.
The contract is not a comprehensive contract, but a contract for the review of each clinical trial, and the title of the clinical trial is indicated in the contract.
I understand that the head of the medical institution, who is the contract signer, uses the clinical trial request form to understand the content of the clinical trial that needs to be reviewed, determines which committee should be asked to review it, and if the selected committee is external, concludes an "entrusted review agreement. If this is correct, I think it is impossible for the contract of entrustment of review to occur prior to the request for clinical trial. I have submitted the above to the medical institution, but the secretariat of the medical institution (in effect, the SMO) is adamant that the contract review agreement precedes the clinical trial request form. Basically, this is a problem with the medical institution on the outsourcing side, and we plan to conclude an agreement as soon as possible, but we do not understand the essential nature of the issue.
I was aware that the sponsor and the investigator prepare and submit the request for clinical trial and that the head of the medical institution who receives the submission of the request for clinical trial concludes a review agreement with the external clinical trial review committee in that order.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 27, Paragraph 1, Guidance 1 of the GCP, "The head of the site shall select an appropriate investigational review committee for each clinical trial and request it to conduct investigations and deliberations. In addition, GCP Article 30, Paragraph 2 states, "If the head of the implementing medical institution decides to have an external clinical trial review committee conduct investigations and deliberations, he or she must conclude a contract with the establisher of the relevant clinical trial review committee in advance. However, there is no specific provision regarding the timing of the submission of the request for a clinical trial by the sponsor, and the contract can be concluded before or after the submission of the request for a clinical trial.
On the other hand, the sponsor is required to select a medical institution after investigating the information of the investigational review committee before requesting a clinical trial, and to notify the name (name of the corporation and name of the representative) and location of the establisher of the investigational review committee in the clinical trial plan notification form. From the content of your question, it is not clear why the medical institution cannot receive the request for clinical trial from the sponsor, so we can only speculate. However, if, as part of this investigation and response, the sponsor requests that the medical institution hurry to conclude a contract of entrusted review, then it is necessary for the sponsor to request the name, etc., of the investigative review committee selected to conduct the investigation and deliberation. If the medical institution has requested that the investigative committee be concluded quickly as part of its response to the survey, it would be sufficient for the medical institution to inform the sponsor of the name of the investigative committee it has chosen to request the investigation and deliberation of.
In order to avoid the situation described in your question, we recommend that a comprehensive contract be concluded instead of concluding a contract with a medical institution for each clinical trial, from the perspective of streamlining and shortening the duration of the clinical trial procedures.