TY - JOUR
T1 - How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge
AU - Mozersky, Jessica T.
AU - Antes, Alison L.
AU - Baldwin, Kari
AU - Jenkerson, Michelle
AU - DuBois, James M.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was supported by grants from the U.S. National Institutes of Health (Nos UL1TR002345 and K01HG008990).
Funding Information:
The authors thank Bradley Evanoff, Director, Washington University School of Medicine Institute for Clinical and Translational Science for providing financial support for this project; Yi Zhang, Director, Regulatory Support Core, Washington University School of Medicine Institute for Clinical and Translational Science for serving as a project advisor; Susan Budinger, Associate Director of Research Operations, Duke Office of Clinical Research, Duke University School of Medicine for coordinating survey distribution; and Stephanie Swords, Program Director?Study Coordinator Apprenticeship and Mentoring Program (SCAMP) & Research Coordinator Support Service (RCSS), Johns Hopkins University Institute for Clinical and Translational Research for coordinating survey distribution. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project was supported by grants from the U.S. National Institutes of Health (Nos UL1TR002345 and K01HG008990).
Funding Information:
The authors thank Bradley Evanoff, Director, Washington University School of Medicine Institute for Clinical and Translational Science for providing financial support for this project; Yi Zhang, Director, Regulatory Support Core, Washington University School of Medicine Institute for Clinical and Translational Science for serving as a project advisor; Susan Budinger, Associate Director of Research Operations, Duke Office of Clinical Research, Duke University School of Medicine for coordinating survey distribution; and Stephanie Swords, Program Director—Study Coordinator Apprenticeship and Mentoring Program (SCAMP) & Research Coordinator Support Service (RCSS), Johns Hopkins University Institute for Clinical and Translational Research for coordinating survey distribution.
Publisher Copyright:
© The Author(s) 2020.
PY - 2020/4/1
Y1 - 2020/4/1
N2 - Background: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health–funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. Methods: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal–numerical reasoning and learning orientation. Results: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). Conclusion: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training—whether online or face to face—does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.
AB - Background: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health–funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. Methods: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal–numerical reasoning and learning orientation. Results: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). Conclusion: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training—whether online or face to face—does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.
KW - Good Clinical Practice
KW - clinical research coordinators
KW - knowledge
UR - http://www.scopus.com/inward/record.url?scp=85078410320&partnerID=8YFLogxK
U2 - 10.1177/1740774519893301
DO - 10.1177/1740774519893301
M3 - Article
C2 - 31984765
AN - SCOPUS:85078410320
SN - 1740-7745
VL - 17
SP - 166
EP - 175
JO - Clinical Trials
JF - Clinical Trials
IS - 2
ER -