Risk assessment of investigator initiated trials at the proposal stage
10.3760/cma.j.cn111325-20210531-00487
- VernacularTitle:研究者发起的临床研究项目立项阶段风险评估探讨
- Author:
Wenwen LYU
1
;
Tingting HU
;
Weituo ZHANG
;
Tiantian QU
;
Enlu SHEN
;
Jiacheng DUAN
;
Zhe SUN
;
Jian WANG
;
Biyun QIAN
Author Information
1. 上海交通大学医学院临床研究中心 200025
- Keywords:
Scientific research management;
Investigator initiated trial;
Risk assessment;
Proposal stage
- From:
Chinese Journal of Hospital Administration
2021;37(11):927-931
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess possible risk factors and their respective levels in the whole process of investigator initiated trial(IIT)projects proposed in the proposal stage, for reference in formulation of risk management plans.Methods:Through literature analysis and research group discussions, the risk factors of IIT projects and risk level assessment criteria were preliminarily identified, and a consultation questionnaire was developed as a result. Delphi method was used to further optimize the risk factors and determine their risk levels. Data obtained from the consulfation were analysied by descriptive.Results:The recovery rates of two rounds of expert consultation were both 100%, and the degree of expert authority was 0.942. The survey finalized 38 risk factors, including extremely high risk, high risk, medium risk, low risk and very low risk factors of 17(44.7%), 15(39.5%), 3(7.9%), 2(5.3%) and 1(2.6%) respectively.Conclusions:This study determined a risk evaluation system of IIT projects in the proposal stage. This system can identify risks of IIT projects at an early stage, facilitating early intervention of problems existing in such projects, and minimize risks to the rights and safety of patients.
