Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study

被引：2

作者：

DuBois, James M. ^{[1
]}

Mozersky, Jessica T. ^{[1
]}

Antes, Alison L. ^{[1
]}

Baldwin, Kari ^{[1
]}

Jenkerson, Michelle ^{[1
]}

机构：

[1] Washington Univ, Sch Med, St Louis, MO USA

来源：

JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE | 2020年 / 4卷 / 02期

基金：

美国国家卫生研究院;

关键词：

Good clinical practice; clinical research coordinators; clinical trials; testing; validation; measurement; knowledge; RESPONSIBLE CONDUCT; INSTRUCTION;

D O I：

10.1017/cts.2019.440

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (alpha = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals' mastery of GCP content.

引用

页码：141 / 145

页数：5

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