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Question: 想请教一下各位,目前对于聘用CRC的合同管理,目前业内的做法是什么?申办方、site和CRO签署三方协议的方式是否可以接受?合同中会明确CRC的聘用和管理由PI负责,PI负责计算工作量,申办方只负责付款。避免利益冲突。签三方的原因是有些医院不愿意和CRO直接签合同,签三方的同时,申办方和CRO会额外签一份合同,明确付款问题。这种操作在去两年是有的,不知道现在有没有更严格规定,只能site和CRO签合同,site直接管理?之前广东省有个CRC管理的研讨会达成的共识是不推荐三方合同的,但是后续没有看到讨论的终版文件。
Answer: Clinical research coordinator (CRC) role is to assist investigator to conduct clinical trials at the site. ICH GCP E6 4.2.3 states that “The investigator should have available an adequate number qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely. It is advisable to have a contract between an investigator site and a CRC company only. The contract should clearly describe each party’s roles and tasks. It is ultimately the investigator’s responsibility. A contract is a legal document and the agreement between parties.