Drug Evaluation Committee 2020-51 Procedures for changing SMO
Related classification: Clinical trial contract procedures
First published: Apr. 2021
Question
Our company provides SMO services.
We provide CRC and clinical trial secretariat services for a corporate clinical trial being conducted at a certain clinic, and we also provide IRB secretariat support services since the IRB has requested our central IRB to provide IRB services.
The clinical trial is still ongoing, but we have decided to change the SMO to another company (let's call it Company A).
After discussion with the sponsor and CRO, we have decided to request the new SMO to provide CRC and clinical trial secretariat services, and to continue requesting IRB services from our central IRB, so we will provide IRB secretariat support services.
Under GCP, is it acceptable to use the following documents for the handover of work?
- Contract Research Collaboration Agreement between Company A and Investigator Site
(Company A CRC will be added to the list of investigators and collaborators after the contract research collaboration agreement is concluded.) - Memorandum of Understanding (MOU) and quotation for clinical trial costs currently being concluded,
- (After the conclusion of the contract research agreement, Company A's CRC will be added to the list of investigators and collaborators of Company A.)
- Record of completion of handover of tasks
The confidentiality agreement between Company A and our company has already been executed.
In addition, the contract of entrustment between our company and Investigator Site will not be terminated and will be continued in order to be able to respond to any future audits or on-site inspections.
We would appreciate it if you could provide us with any other necessary documents in addition to the above.
JPMA's Opinion
Guidance 1 of Article 39-2 of the GCP states, "When entrusting a part of the operations related to the conduct of a clinical trial, the Investigator Site shall conclude an agreement with the trustee of such operations," and Guidance 3 of the same article states, "The Investigator Site and the trustee shall agree in writing on the scope of entrusted operations, matters related to the procedures for entrusted operations, and the procedures for entrusted operations. Guidance 3 of the same article states that "the Investigator Site and the contractor shall conclude an agreement in writing that describes the scope of the entrusted services, matters related to the procedures for the entrusted services, and the fact that the Investigator Site can confirm whether the entrusted services are being performed properly and smoothly based on the procedures" and Guidance 5 of the same article states that "all services related to the clinical trial that the Investigator Site entrusted to the contractor shall be clearly described in the document exchanged with the contractor". Guidance 5 of the same article states, "All work related to a clinical trial entrusted to a trustee by a medical institution shall be clearly stated in the document exchanged with the trustee.
In addition, the Voluntary Guidelines for the Proper Implementation of SMO Contract Services (prepared on April 22, 2005), 12. Conclusion of Contract Services, states that "In principle, the contract should be a two-party contract with the sponsor, but a three-party contract including the sponsor or a four-party contract when the sponsor is using a contract research organization (CRO) is possible. However, if the sponsor uses a contract research organization (CRO), a three-party contract including the sponsor or a four-party contract is possible. However, items may be added or deleted as appropriate depending on the nature of the contracted services. The following is a description of the contractual agreement.
Therefore, if the Investigator Site and Company A conclude a bilateral agreement regarding the outsourcing of part of the work related to the implementation of the clinical trial, or if the Investigator Site and the company to which the person in question belongs conclude a bilateral agreement regarding the termination of the outsourced work as necessary, or if the company to which the person in question belongs and Company A conclude a bilateral agreement regarding the termination of the outsourced work as necessary, then the Investigator Site, Company A, and Company A must conclude an agreement regarding the termination of the outsourced work as necessary. In cases where there are agreements between the Investigator Site, Company A, and the company to which the inquirer belongs, a three-party agreement (or a four-party agreement including the sponsor) may be entered into. It is necessary to clearly state in the contract the duties entrusted to Company A, and it is also necessary to clarify in writing when the CRC duties and clinical trial secretariat duties were changed to Company A. In addition, we recommend that the records of the handover of duties mentioned in your question be retained as they are important records in explaining the clinical trial. We would like you to consult with the Investigator Site to determine what kind of records should be kept.