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...

Full description

Bibliographic Details
Main Authors: Claudia S. Plottel, Lois Mannon, Frederick G. More, Stuart D. Katz, Judith S. Hochman
Format: Article
Language:English
Published: Cambridge University Press 2018-12-01
Series:Journal of Clinical and Translational Science
Subjects:
Online Access:https://www.cambridge.org/core/product/identifier/S2059866119000050/type/journal_article
_version_ 1811156830855888896
author Claudia S. Plottel
Lois Mannon
Frederick G. More
Stuart D. Katz
Judith S. Hochman
author_facet Claudia S. Plottel
Lois Mannon
Frederick G. More
Stuart D. Katz
Judith S. Hochman
author_sort Claudia S. Plottel
collection DOAJ
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.
first_indexed 2024-04-10T04:57:40Z
format Article
id doaj.art-1033044afc3d4c2ea07995ebee6cf401
institution Directory Open Access Journal
issn 2059-8661
language English
last_indexed 2024-04-10T04:57:40Z
publishDate 2018-12-01
publisher Cambridge University Press
record_format Article
series Journal of Clinical and Translational Science
spelling doaj.art-1033044afc3d4c2ea07995ebee6cf4012023-03-09T12:29:41ZengCambridge University PressJournal of Clinical and Translational Science2059-86612018-12-01234334910.1017/cts.2019.5Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject researchClaudia S. Plottel0https://orcid.org/0000-0001-6088-6534Lois Mannon1Frederick G. More2Stuart D. Katz3Judith S. Hochman4Department of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USAOffice of Science and Research (OSR), NYU Langone Health, New York, New York, USAOffice of Science and Research (OSR), NYU Langone Health, New York, New York, USA NYU College of Dentistry, New York, New York, USADepartment of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USADepartment of Medicine, New York University School of Medicine, New York, New York, USA NYU-H+H Clinical Translational Science Institute, New York, New York, USAThe 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.https://www.cambridge.org/core/product/identifier/S2059866119000050/type/journal_articlePINDARcourse developmentgood clinical practice (CGP)principal investigator traininghuman subject research
spellingShingle Claudia S. Plottel
Lois Mannon
Frederick G. More
Stuart D. Katz
Judith S. Hochman
Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research
Journal of Clinical and Translational Science
PINDAR
course development
good clinical practice (CGP)
principal investigator training
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 PINDAR
course development
good clinical practice (CGP)
principal investigator training
human subject research
url https://www.cambridge.org/core/product/identifier/S2059866119000050/type/journal_article
work_keys_str_mv AT claudiasplottel designimplementationandevaluationofpindaranovelshortprogramongcpforacademicmedicalcenterprincipalinvestigatorsconductinghumansubjectresearch
AT loismannon designimplementationandevaluationofpindaranovelshortprogramongcpforacademicmedicalcenterprincipalinvestigatorsconductinghumansubjectresearch
AT frederickgmore designimplementationandevaluationofpindaranovelshortprogramongcpforacademicmedicalcenterprincipalinvestigatorsconductinghumansubjectresearch
AT stuartdkatz designimplementationandevaluationofpindaranovelshortprogramongcpforacademicmedicalcenterprincipalinvestigatorsconductinghumansubjectresearch
AT judithshochman designimplementationandevaluationofpindaranovelshortprogramongcpforacademicmedicalcenterprincipalinvestigatorsconductinghumansubjectresearch