Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research

Claudia S. Plottel; Lois Mannon; Frederick G. More; Stuart D. Katz; Judith S. Hochman

doi:10.1017/cts.2019.5

Journal of Clinical and Translational Science (Dec 2018)

Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research

Claudia S. Plottel,
Lois Mannon,
Frederick G. More,
Stuart D. Katz,
Judith S. Hochman

Affiliations

Claudia S. Plottel: ORCiD; Department of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USA
Lois Mannon: Office of Science and Research (OSR), NYU Langone Health, New York, New York, USA
Frederick G. More: Office of Science and Research (OSR), NYU Langone Health, New York, New York, USA NYU College of Dentistry, New York, New York, USA
Stuart D. Katz: Department of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USA
Judith S. Hochman: Department of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USA

DOI: https://doi.org/10.1017/cts.2019.5
Journal volume & issue: Vol. 2
pp. 343 – 349

Abstract

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The Principal INvestigator Development and Resources (PINDAR) program was developed at the NYU-H+H Clinical and Translational Science Award (CTSA) hub in response to a perceived need for focused good clinical practice (GCP) training designed specifically for principal investigators (PIs) performing human subject research. PINDAR is a novel 6-hour, instructor lead, participatory, in-person course for PIs developed de novo, piloted, and implemented. One hundred and seventeen faculty PIs participated in PINDAR from November 2016 through September 2018. All obtained mutual recognition for ICH E6 GCP training from TransCelerate Biopharma. PINDAR was well received by participant PIs, and feedback surveys have revealed a high degree of satisfaction with the program. Other CTSA hubs and research-intensive health systems should consider adopting a similar course focused on GCP for PIs.

Published in Journal of Clinical and Translational Science

ISSN: 2059-8661 (Online)
Publisher: Cambridge University Press
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://www.cambridge.org/core/journals/journal-of-clinical-and-translational-science

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Abstract

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