Preliminary study of risk management mode for investigator-initiated clinical trials
10.3760/cma.j.issn.1006-1924.2019.06.017
- VernacularTitle:研究者发起的临床研究风险管理模式探讨
- Author:
Xiaoyan TAN
1
;
Liling LIN
;
Wentao TANG
;
Tao CEN
;
Hong LU
Author Information
1. 南方医科大学南方医院科研处
- Keywords:
Investigator-initiated clinical trial;
Risk management;
Risk assessment;
Risk control
- From:
Chinese Journal of Medical Science Research Management
2019;32(6):474-478
- CountryChina
- Language:Chinese
-
Abstract:
Objective To explore the risk management model of investigator-initiated clinical trials (IITs) from the prospective of clinical research management personnel,to provide further reference for its construction and implementation in China.Methods The risks in IITs and its current situation of risk management were analyzed.Risk management standards including ISO 31000 and related guidelines were adopted to explore the risk management mode for China-based IIT.Results This article proposed the new risk management mode for IITs and also introduced the specified frame and procedures of related risk management.Conclusions The risk management model proposed in this article provided reference for clinical research management.
