Drug Evaluation Committee 2020-51 Procedures for changing SMO
Related classification: clinical trial contracting procedures
First published: Apr. 2021
Question
Our company is engaged in SMO services.
We provide CRC and clinical trial secretariat services for a corporate clinical trial being conducted at a clinic, and we also provide IRB secretariat support services since the IRB is requested by our central IRB.
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 the 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,
- Conclusion of a memorandum of understanding (MOU) for changes between the sponsor, investigational sites, Company A, and our company.
- Record of completion of handover of tasks
We have already concluded a nondisclosure agreement between Company A and our company.
In addition, we plan to continue the contract of entrustment between our company and the executing medical institution without terminating it 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.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 39-2 Guidance 1 of the GCP states, "When entrusting a part of work related to the conduct of a clinical trial, the site must conclude a contract with the trustee of the work. Guidance 3 of the same article states, "The executing medical institution and the trustee shall conclude a contract in writing that describes the scope of the entrusted work, matters related to the procedures of the entrusted work, and the fact that the executing medical institution can confirm whether the entrusted work is being performed appropriately and smoothly based on the procedures. Guidance 5 of the same article states, "All work related to a clinical trial entrusted to a trustee by a medical institution should 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 a two-party contract is concluded between the medical institution and Company A regarding the entrustment of part of the operations related to the implementation of a clinical trial by the medical institution and the company to which the person in question belongs, or if there are agreements between the company to which the person in question belongs and Company A regarding the termination of the entrusted operations as necessary, then the medical institution and Company A should conclude a two-party contract. In cases where there are agreements between the sponsor and Company A, a three-party agreement (or a four-party agreement including the sponsor) may be concluded between the sponsor, Company A, and the company to which the inquirer belongs. 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 site to determine what kind of records should be kept.