Drug Evaluation Committee 2011-37 Order of Clinical Trial Request Form and Contract Review Agreement
Related classification: Clinical Trial Review Committee
First published: 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 blanket 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 Chairperson of the medical institution who concludes the contract understands the contents of the clinical trial that needs to be reviewed based on the clinical trial request form, determines which committee to request for review, 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, so 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 investigator prepare and submit the clinical trial request form, and that the Investigator Site Chairperson, upon receiving the submission, enters into a review agreement with an external clinical trial review committee.
JPMA's Opinion
According to Article 27, Paragraph 1, Guidance 1 of the GCP, "The Investigator Site Chairperson shall select an appropriate Clinical Trial Review Committee for each clinical trial and request it to conduct investigations and deliberations. In addition, GCP Article 30, Paragraph 2 states, "If the Investigator Site Chairperson decides to have an external Clinical Trial Review Committee conduct the investigation and deliberation, he or she must conclude a contract with the establisher of that 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 Investigator Site after investigating the information of the Investigator Site 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 Investigator Site in the clinical trial plan notification form. From the content of your question, it is not clear why the medical institution could not receive the request for clinical trial from the sponsor, so we can only speculate. However, if the sponsor has requested that the medical institution hurry up to conclude a contract of entrusted review as part of its response to this investigation, it would be necessary for the sponsor to request the name, etc., of the investigative committee it has 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, it is recommended to conclude a comprehensive agreement with the Investigator Site rather than concluding an agreement for each clinical trial from the viewpoint of streamlining the clinical trial procedures and shortening the time period.