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

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...

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Autores principales: Plottel, Claudia S., Mannon, Lois, More, Frederick G., Katz, Stuart D., Hochman, Judith S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2019
Materias:
Special Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676438/
https://www.ncbi.nlm.nih.gov/pubmed/31404275
http://dx.doi.org/10.1017/cts.2019.5
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author Plottel, Claudia S.
Mannon, Lois
More, Frederick G.
Katz, Stuart D.
Hochman, Judith S.
author_facet Plottel, Claudia S.
Mannon, Lois
More, Frederick G.
Katz, Stuart D.
Hochman, Judith S.
author_sort Plottel, Claudia S.
collection PubMed
description 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.
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spelling pubmed-66764382019-08-09 Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research Plottel, Claudia S. Mannon, Lois More, Frederick G. Katz, Stuart D. Hochman, Judith S. J Clin Transl Sci Special Communication 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. Cambridge University Press 2019-05-14 /pmc/articles/PMC6676438/ /pubmed/31404275 http://dx.doi.org/10.1017/cts.2019.5 Text en © The Association for Clinical and Translational Science 2019 https://creativecommons.org/licenses/by-ncnd/4.0/ This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (https://creativecommons.org/licenses/by-ncnd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
spellingShingle Special Communication
Plottel, Claudia S.
Mannon, Lois
More, Frederick G.
Katz, Stuart D.
Hochman, Judith S.
Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title_full Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title_fullStr Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title_full_unstemmed Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title_short Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
title_sort design, implementation, and evaluation of pindar, a novel short program on gcp for academic medical center principal investigators conducting human subject research
topic Special Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6676438/
https://www.ncbi.nlm.nih.gov/pubmed/31404275
http://dx.doi.org/10.1017/cts.2019.5
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