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Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study
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 rarel...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7159812/ https://www.ncbi.nlm.nih.gov/pubmed/32313704 http://dx.doi.org/10.1017/cts.2019.440 |
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author | DuBois, James M. Mozersky, Jessica T. Antes, Alison L. Baldwin, Kari Jenkerson, Michelle |
author_facet | DuBois, James M. Mozersky, Jessica T. Antes, Alison L. Baldwin, Kari Jenkerson, Michelle |
author_sort | DuBois, James M. |
collection | PubMed |
description | 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 (α = 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. |
format | Online Article Text |
id | pubmed-7159812 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-71598122020-04-20 Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study DuBois, James M. Mozersky, Jessica T. Antes, Alison L. Baldwin, Kari Jenkerson, Michelle J Clin Transl Sci Brief Report 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 (α = 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. Cambridge University Press 2020-02-19 /pmc/articles/PMC7159812/ /pubmed/32313704 http://dx.doi.org/10.1017/cts.2019.440 Text en © The Association for Clinical and Translational Science 2020 http://creativecommons.org/licenses/by/4.0/ This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Brief Report DuBois, James M. Mozersky, Jessica T. Antes, Alison L. Baldwin, Kari Jenkerson, Michelle Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title | Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title_full | Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title_fullStr | Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title_full_unstemmed | Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title_short | Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study |
title_sort | assessing clinical research coordinator knowledge of good clinical practice: an evaluation of the state of the art and a test validation study |
topic | Brief Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7159812/ https://www.ncbi.nlm.nih.gov/pubmed/32313704 http://dx.doi.org/10.1017/cts.2019.440 |
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