摘要
目的:阐述各类跟踪审查的操作程序和审查要点。方法:介绍伦理审查中各类跟踪审查(复审、修正案审查、年度/定期跟踪审查、严重不良事件审查、违背方案审查、提前终止研究审查、结题审查)的定义、需要递交的文件、操作程序与审查要点。结果和结论:伦理委员会对临床研究的审查不只是局限于在研究开始前的审查,还包括研究开始以后的跟踪审查。只有重视对临床研究全过程的伦理审查,才能把对受试者的保护落到实处。
Objective： Illustrate the operating procedure and ethical consideration for ongoing review respectively. Methods： Introduction the definition, materials need to be submitted, the operating procedure and ethical consideration of all kinds of ongoing review： Review of Resubmitted Protocols, Annually or Periodic Continuing Review, Review of Protocol Amendments, Review of Adverse Events, Review of Protocol Violation, Review of Study Termination, and Review of Final Report. Results and Conclusions： Besides Initial Review conducted before commencement of clinical research, Ethical review of clinical research also encompasses Follow-up Review or Ongoing Review. Only after reviewing the whole procedures of clinical research, will protection of the subject be realized.
出处
《药品评价》
CAS
2011年第4期13-16,共4页
Drug Evaluation
关键词
临床研究
伦理委员会
跟踪审查
Clinical Research
Institutional Review Board
Ongoing Review
