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A paired training curriculum and internal monitoring program for clinical research regulatory compliance in the emerging era of the single Institutional Review Board

  • T. Che Jarrell (a1), Frances Hamblin (a1), Daniel E. Ford (a2), Sylvia R. Powell (a3), Jonathan M. Ellen (a3) (a4) and Neil A. Goldenberg (a1) (a3) (a4)...
Abstract
Background

Academic health systems and their investigators are challenged to systematically assure clinical research regulatory compliance. This challenge is heightened in the emerging era of centralized single Institutional Review Boards for multicenter studies, which rely on monitoring programs at each participating site.

Objective

To describe the development, implementation, and outcome measurement of an institution-wide paired training curriculum and internal monitoring program for clinical research regulatory compliance.

Methods

Standard operating procedures (SOPs) were developed to facilitate investigator and research professional adherence to institutional policies, federal guidelines, and international standards. An SOP training curriculum was developed and implemented institution-wide. An internal monitoring program was launched, utilizing risk-based monitoring plans of pre-specified frequency and intensity, assessed upon Institutional Review Boards approval of each prospective study. Monitoring plans were executed according to an additional SOP on internal monitoring, with monitoring findings captured in a REDCap database.

Results

We observed few major violations across 3 key domains of clinical research conduct and demonstrated a meaningful decrease in the rates of nonmajor violations in each, over the course of 2 years.

Conclusion

The paired training curriculum and monitoring program is a successful institution-wide clinical research regulatory compliance model that will continue to be refined.

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Copyright
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.
Corresponding author
*Address for correspondence: N. Goldenberg, M.D., Ph.D., Johns Hopkins All Children’s Hospital, 501 6th Avenue South, St. Petersburg, FL 33701, USA (Email: neil@jhmi.edu)
References
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4. Goldenberg NA, Daniels SR, Mournai PM, Hamblin F, Stowe A, Powell S, Ford DE, Ellen J. Enhanced infrastructure for optimizing the design and execution of clinical trials and longitudinal cohort studies in the era of precision medicine. The Journal of Pediatrics 2016; 171: 300306.
5. Clinical Trials Monitoring Branch, Cancer Therapy Evaluation Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute. NCI Guidelines for Auditing Clinical Trials for the NCI National Clinical Trials Network (NCTN) Program, Community Clinical Oncology Program (CCOP)/NCI Community Oncology Research Program (NCORP) and Research Bases [Internet]. [cited May 15, 2017]. (https://ctep.cancer.gov/branches/ctmb/clinicaltrials/docs/ctmb_audit_guidelines.pdf).
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Journal of Clinical and Translational Science
  • ISSN: -
  • EISSN: 2059-8661
  • URL: /core/journals/journal-of-clinical-and-translational-science
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