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Applied Drug Research, Clinical Trials and Regulatory Affairs

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ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

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Perspective

Building and Implementing a Quality Assurance/Quality Improvement Program for Clinical Research

Author(s): Reva Bruns, Marietta Barton-Baxter, Roxane Poskin, Philip A. Kern and William W. Stoops*

Volume 9, Issue 1, 2022

Published on: 03 October, 2022

Article ID: e150622206026 Pages: 8

DOI: 10.2174/2667337109666220615125134

Abstract

Background: A major goal of the Clinical and Translational Science Award programs is to build and grow clinical and translational research, including the need to ensure that study teams are educated and adhere to best clinical research practices.

Objective: One of the primary objectives of the Center for Clinical and Translational Science at the University of Kentucky is to help investigators implement standard operating procedures and provide resources to conduct clinical research that is rigorous, ethical, and safe.

Methods: The University of Kentucky Center for Clinical and Translational Science sought to establish a Quality Assurance/Quality Improvement program for Principal Investigator (PI) initiated clinical research studies using Center for Clinical and Translational Science services. Initiated in 2011, this program’s goal was to improve research design quality and, from the start of the project, “find it, fix it”, leading to improved PI education without being viewed as punitive.

Results: Since the initiation of our Quality Assurance/Quality Improvement program, PI acceptance has been good and we have expanded its footprint and adjusted our review style to better match the needs of our PIs. This article discusses our experiences with Quality Assurance/Quality Improvement program development and growth.

Conclusion: A Quality Assurance/Quality Improvement program can be developed that is efficient, effective, educational, and well accepted by all clinical research stakeholders.

Keywords: Quality assurance, quality improvement, clinical research, good clinical practice, BAL, program development.

[1]
Tannock, L.R.; Barton-Baxter, M.; Stoops, W.W. Creation of an institutional semi-independent data monitoring committee. Clin. Trials, 2019, 16(5), 523-530.
[http://dx.doi.org/10.1177/1740774519859876] [PMID: 31257918]
[2]
ICH harmonised guideline integrated addendum to ICH E6(R1) Guideline for Good Clinicl Practice ICH E6(R2) ICH ConsensusGuideline. Available from: https://ichgcp.net/1-glossary [Accessed on May 18, 2022].
[3]
ICH GCP 5.18.3 Extent and Nature of Monitoring (nd). ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline. Available from : https://ichgcp.net/5-sponsor [Accessed on May 18,2022].
[4]
ICH GCP 5.19 Audit (nd). ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline. Available from: https://ichgcp.net/5-sponsor [Accessed on May 18, 2022].
[5]
CCTS QA/QI Toolbox (nd) Available from: https://www.ccts.uky.edu/index.php/services-resources-researchers/quality-assurancequality-improvement [Accessed on May 18, 2022].
[6]
ICH GCP 5.1 Quality Assurance and Quality Control (nd). ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2) ICH Consensus Guideline. Available from : https://ichgcp.net/5-sponsor [Accessed on May 18, 2022].
[7]
Tucker, A.L. Implementing new practices: An empirical study of organizational learning in hospital intensive care units. Manag. Sci., 2007, 53(6), 894-907.
[http://dx.doi.org/10.1287/mnsc.1060.0692]
[8]
PI Self-Assessment Reviews (nd) Reference Available from: https://www.research.uky.edu/office-research-integrity/quality-assuranceimprovement-program-human-research-protections [Accessed on May 18, 2022
[9]
Center for Clinical and Translational Science IRB/ORI Coordination (C6.0950). 2020. Available from : https://www.research.uky.edu/office-research-integrity/policies-guidance [Accessed on May 18, 2022].
[10]
CCTS CRSO Research Navigator Services (nd). 2020. Available from: https://www.ccts.uky.edu/services-resources-researchers/cctscrso-research-navigator-services [Accessed on May 18, 2022].
[11]
PI 101 (nd). 2020. Available from: https://www.ccts.uky.edu/index.php/about-ccts/cores/regulatory-knowledge-and-support-core/principal-investigator-101 [Accessed on May 18, 2022].
[12]
NIH Clinical Trial definition (nd). Available from :https://grants.nih.gov/policy/clinical-trials/definition.htm [Accessed on May 18, 2022].
[13]
Remote Monitoring of Clinical Research Studies (nd). Available from : https://www.ccts.uky.edu/about-ccts/cores/regulatory-knowledge-and-support-core/remote-monitoring-clinical-trials [Accessed on May 18, 2022].

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