首页|药物临床试验机构项目管理工作要点实践与思考

药物临床试验机构项目管理工作要点实践与思考

扫码查看
新药注册上市临床试验是检验其有效性及安全性的最后一环,药物临床试验需在备案的医疗机构开展,作为医疗机构临床试验管理部门,临床试验项目在医疗机构开展,药物临床试验机构作为负责沟通、协调、监管、培训的重要角色,需协助做好项目推荐及受理、项目立项评估、合同审查、协助项目启动、项目质控管理、档案管理、药物管理、项目经费管理及项目结题管理工作等,药物临床试验机构需要积极采取高效的管理流程,才能保证临床试验真实、规范,切实保障申办方、研究者及受试者等各方需求.
Practice and thinking on key points of project management in Drug Clinical Trial Institutions
Whether new drugs can be registered and listed,clinical trial is testing its effectiveness and safety of the final ring.Drug clinical trials should be conducted in registered medical institutions,as the clinical trial management department of medical institutions,clinical trials are conducted in medical institutions.Drug clinical trial institutions play an important role in communication,coordination,supervision and training in the development of clinical trial projects in medical institutions.They need to assist in project recommendation and acceptance,project evaluation,contract review,project start-up,project quality control management,file management,drug management,project fund management and project closing management,etc.As a clinical trial management of medical institutions,drug clinical trial institution needs to take active and efficient management process,to ensure the truthfulness,specification of clinical trials,ensure the sponsors,researchers and subjects such as demand.

Drug clinical trialDrug clinical trial institutionsProject managementPracticeThinking

莫霞

展开 >

广东省妇幼保健院药物临床试验科,广州 510010

药物临床试验 药物临床试验机构 项目管理 实践 思考

2023

中国处方药
南方医药经济研究所

中国处方药

影响因子:0.649
ISSN:1671-945X
年,卷(期):2023.21(12)
  • 16