Risk assessment, prevention and control of drug clinical trial institutions
10.3760/cma.j.issn.1006-9801.2019.06.011
- VernacularTitle:药物临床试验机构的风险评估与防控
- Author:
Jiping ZHANG
1
;
Xiaoxia WANG
;
Hong WANG
;
Yi ZHAO
;
Junqin LU
;
Minmin CHEN
Author Information
1. 山西医科大学第二医院临床试验机构办公室
- Keywords:
Drug clinical trial;
Drug clinical trial institution;
Risk management
- From:
Cancer Research and Clinic
2019;31(6):409-411
- CountryChina
- Language:Chinese
-
Abstract:
The management of drug clinical trial institutions from the risk management point of view is investigated. According to the technology of risk assessment in risk management, taking the project audit as an example, basing on the basic procedures of risk identification, risk assessment and risk control, making 8 risk factors into the table of risk management for project approval of clinical trial in order to initially establish a risk management of drug clinical trial institutions. In this way, the management quality of project for drug clinical trials will be probably improved, so that the risk incidence rate will be effectively reduced in the later phase of clinical trial.
