Drug Evaluation Committee 2011-57 Cancellation of CRC dispatch contract during a clinical trial
Related classification: Other
Date of first publication: Apr. 2012
Question
An SMO withdrew from a contract with our hospital in the middle of a clinical trial. In this case, is there any need for a memorandum of understanding between the SMO and our hospital, the SMO and our hospital, and the sponsor regarding the termination of the contract?
Also, the CRC fees were paid directly to the SMO by the sponsor. Is something necessary in that case as well?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Generally, unless otherwise stipulated in the initial contract, a memorandum of understanding is not required for mid-term termination. If there is no provision in the original contract regarding the handling of expenses or the handling of clinical trial operations upon termination, and if there is a need for a new agreement between the two parties, it would be sufficient to conclude a new memorandum of understanding, etc., and terminate the (dispatched) CRC's services after appropriately handing over the contents of the services. In addition, if payment is made directly to the SMO by the sponsor, a memorandum of understanding is generally not necessary, but the sponsor should be notified as early as possible.