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Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results

  • Clinical Research
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Abstract

Data from clinical studies generated by practice-based research networks (PBRNs) should be generalizable to the health care profession. For nationally representative data, a broad recruitment of practitioners may pose added risks to institutional review boards (IRBs). Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are widely accepted across medical disciplines. The PEARL Network is an interdisciplinary dental/medical PBRN conducting a broad range of clinical studies. The infrastructure is designed to support the principles of good clinical practice (GCP) and create a data audit trail to ensure data integrity for generalizability. As the PBRN concept becomes of greater interest, membership may expand beyond the local community, and the issue of geography versus risk management becomes of concern to the IRB. The PEARL Network describes how it resolves many of the issues related to recruiting on a national basis while maintaining study compliance to ensure patient safety and minimize risk to the IRB.

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Authors and Affiliations

  1. PEARL Network Executive Management Team, New York University, College of Dentistry, 380 2nd Ave, Suite 302, New York, NY, USA

    Frederick Curro DMD, PhD (Director), P. Van Thompson DDS, PhD & Louis Terracio PhD

  2. NYU School of Medicine, New York, NY, USA

    Frederick Naftolin MD, PhD & Elan Czeisler MA, CIP

  3. NYU College of Dentistry, New York, NY, USA

    Ashley Grill RDH, BSDH, MPH, Mariko Hashimoto MSW, CCRA, Matthew Buchholz MS, CCRA, Andrea McKinstry BS, Diane Cannon RDH, BSDH, Vincent Alfano BS, Thalia Gooden DO, CCRA & Anthony Vernillo DDS, PhD, MBE

  4. EMMES Corporation, Rockville, MD, USA

    Don Vena BS

Authors
  1. Frederick Curro DMD, PhD
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  2. P. Van Thompson DDS, PhD
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  3. Frederick Naftolin MD, PhD
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  4. Ashley Grill RDH, BSDH, MPH
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  5. Don Vena BS
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  6. Louis Terracio PhD
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  7. Mariko Hashimoto MSW, CCRA
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  8. Matthew Buchholz MS, CCRA
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  9. Andrea McKinstry BS
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  10. Diane Cannon RDH, BSDH
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  11. Vincent Alfano BS
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  12. Thalia Gooden DO, CCRA
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  13. Anthony Vernillo DDS, PhD, MBE
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  14. Elan Czeisler MA, CIP
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Corresponding author

Correspondence to Frederick Curro DMD, PhD.

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Curro, F., Van Thompson, P., Naftolin, F. et al. Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results. Ther Innov Regul Sci 47, 82–89 (2013). https://doi.org/10.1177/0092861512456284

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  • DOI: https://doi.org/10.1177/0092861512456284

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