药物试验合同管理在医院管理中的体现及应用价值

目的:探讨影响医院管理药物试验合同的多重因素,加强对药物试验合同管理的规范性和科学性,建立标准化合同审议和谈判流程,以期高效地完成药物临床实验。方法:概括归纳本院在药物试验合同管理中出现的常见问题,结合现行的药物试验合同管理法律法规,针对性地提出合理可行的对策建议。结果:利用信息化技术并制定合同管理制度,明确各方的权利义务,加强临床试验成本核算、建立公平合理的劳务分配制度、提高临床试验合同和经费的审批效率,完善合同档案管理以达到科学规范地管理药物临床试验合同,保障受试者以及研究机构的合法权益。结论:加强临床试验合同管理,有助于提高医院的管理水平和药物临床试验的开展,保证药物试验结果的可信性和受试者的利益。

The embodiment and application value of drug test contract management in hospital management

OBJECTIVE To explore the factors that affect the management of drug trial contracts in hospitals,to strengthen the standardization and scientificity of drug trial contract management,and to establish a standardized contract review and negotiation process in order to efficiently complete drug clinical trials.METHODS The common problems in drug trial contract management in our hospital were summarized,and the reasonable and feasible countermeasures were put forward according to the current drug trial contract management laws and regulations.RESULTS We should utilize information technology and establish contract management system,clarify the rights and obligations of all parties,strengthen clinical trial cost accounting,establish fair and reasonable labor distribution system,improve the efficiency of review and approval of clinical trial contracts and funds,improve contract file management to achieve scientific and standardized management of drug clinical trial contracts while protecting the legitimate rights and interests of subjects and research institutions.CONCLUSION Strengthening the contract management of clinical trials is helpful to improve the management level of hospitals and the development of drug clinical trials,so as to ensure the credibility of drug trial results and the interests of the subjects.