Details

Autor(en) / Beteiligte

• DuBois, James M
• Mozersky, Jessica T
• Antes, Alison L
• Baldwin, Kari
• Jenkerson, Michelle

Titel

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

Ist Teil von

• Journal of clinical and translational science, 2020-04, Vol.4 (2), p.141-145

Ort / Verlag

England: Cambridge University Press

Erscheinungsjahr

2020

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• 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 ( = 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.