Construction of the evaluation model for Clinical Research Coordinator in Investigator-Initiated Trial
10.3760/cma.j.cn113565-20240915-00242
- VernacularTitle:研究者发起的临床研究协调员核心胜任力评价模型的构建
- Author:
Xian XIE
1
;
Lingyan CHEN
;
Wenyuan DONG
;
Wentao SHI
;
Feng XU
Author Information
1. 上海交通大学医学院附属第九人民医院临床研究中心，上海 200011
- Publication Type:Journal Article
- Keywords:
Investigator-Initiated Trial;
Clinical Research Coordinator;
Core competency;
Evaluation model
- From:
Chinese Journal of Medical Science Research Management
2025;38(1):13-20
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to construct an evaluation index system suitable for the core competency of Clinical Research Coordinators (CRCs) in Investigator-Initiated Trials (IITs) in China.Methods:This study developed a system framework through the Onion Model, literature research, and expert interviews, utilized the Delphi method to build the index system. and analyzed the weight of each indicator through the Analytic Hierarchy Process (AHP).Results:Four first-level indicators were basic knowledge (0.143), job skills (0.300 8), professional quality (0.483 9), and personality traits (0.072 3). Besides, 18 second-level indicators and 49 third-level indicators were developed through the Delphi method. According to the third round expert′s consultation, the average scores of all indexes were >3.50, the authoritative coefficient was 0.86, the coefficient of variation of each index was <0.30, and Kendall coefficients of concordance were 0.183~0.366 ( P<0.001). The consistency ratios of single-sort were<0.1, and the overall sort of all indexes was 0.043 7, which showed good logical reliability. Conclusions:This evaluation index system for Clinical Research Coordinators is of great scientific sense. It provides IIT-conducting investigators in institutions with a proficient assessment tool to help them find qualified and reliable CRCs.
