Drug Evaluation Committee 2013-53 Clinical Trial Agreements with Details that Differ from the Form for Performing Medical Institutions
Related classification: clinical trial contracting procedures
First published: March 2014
Question
We are currently in the process of coordinating with a new company for a clinical trial contract, and we have found out that the payment from the sponsor to the hospital is based on the milestone method.
However, we have been discussing to accept milestone payments in accordance with the concept of global clinical trials, but a question has emerged as to whether this would not fall under the category of non-compliance with SOPs. Although the payment of expenses is a minor matter in terms of content, the hospital has been conducting clinical trials based on the idea that conducting clinical trials in full compliance with SOPs is compliance with GCP, so it is difficult for us to accept the contract for clinical trials unless we can get a clear answer as to whether this matter does not fall under non-compliance with SOPs. I thought that the opinions you have given us here would be a good source of explanation to reassure the hospital, so we consulted with you.
The SOP of hospital XX states that the contract should be concluded using the hospital's contract form. However, the hospital's contract form states, "However, (1) shall be paid when the case is confirmed, (2) and (3) shall be paid after the contract is signed, and (4), (5), (6), and (7) shall be paid to the hospital account each time they are paid. The contract form states that This wording needs to be changed because the milestone method of contracting is not possible with this wording as it is.
If we change the wording of the contract, would it be considered noncompliance with the SOP, since it differs from the contract format described in the SOP (at our hospital)? I thought about concluding a contract only for this different part with a memorandum of understanding, but if the change in wording itself does not fall under SOP non-compliance, then I would like to respond by changing only the relevant wording in the contract, without a memorandum of understanding.
We would like to add flexible wording, such as principles, to the content of the SOP itself so that we can be flexible and not be bound by our own hospital's SOP in the future, but SOP revisions cannot be made immediately, so we are considering a solution in the meantime.
Opinion of the Pharmaceutical Cooperative Association
SOPs set forth standard procedures to be followed in the course of business, and compliance with these procedures is required. However, since contracts are written agreements between two parties, it is common for the terms and conditions to vary depending on the discussions. Therefore, if it is necessary to use a contract that is different from the contract stipulated in the SOP, or if it is necessary to use a contract that is different from the contract stipulated in the SOP, the reason for the change and the content of the contract must be appropriately discussed with the SOP approver or the person responsible for the contract (the hospital director, hospital contract administration officer, the board of directors, or the IRB). We believe that there should be no problem in creating and maintaining a record of the determination by the SOP approver or the person responsible for the contract (the hospital director, the hospital's contract administrator, the board of directors, or a meeting body such as an IRB, depending on the hospital) that the reason for and content of the change are appropriate.
In addition, we believe that one way to address this issue in the future would be to stipulate in the SOP the procedures to be followed when adopting a procedure or format that differs from the SOP, taking into consideration the possibility that similar cases may occur.