Risk Management of Each Actor Involved in Drug Clinical Trials in China
- VernacularTitle:我国新药临床试验参与主体的风险管理
- Author:
Jieqiong XIE
- Keywords:
Clinical trials;
Risk management;
Quality
- From:
China Pharmacist
2017;20(6):1100-1103
- CountryChina
- Language:Chinese
-
Abstract:
From the perspective of risk management, all kinds of risks potentially encountered by each actor involved in the clinical trials in China, including the sponsors, investigators,subjects ethics committee and medical institutions, were analyzed, and some suggestions and expectations on how to minimize the risks were accordingly proposed.Appropriate and effective strategies of risk control and management should be performed to optimize the resource of each actor involved and reduce risks, and eventually to guanrantee the safety of subjects and obtain high quality of study data.
