title: Practice-Based Research Network Infrastructure Design for Institutional Review Board Risk Assessment and Generalizability of Clinical Results.
abstract: Data from clinical studies generated by Practice Based Research Networks should be generalizable to the profession. For nationally representative data a broad recruitment of practitioners may pose added risks to IRB's. Infrastructure must assure data integrity while minimizing risk to assure that the clinical results are generalizable. 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.
authors.affiliation: PEARL Executive Management Team, New York University, College of Dentistry, 380 2nd Ave, Suite 302, New York, NY.
authors.forename: Frederick
authors.initials: F
authors.lastname: Curro
authors.affiliation: PEARL Executive Management Team, New York University, College of Dentistry, 380 2nd Ave, Suite 302, New York, NY.
authors.forename: Van P
authors.initials: VP
authors.lastname: Thompson
authors.affiliation: Medical Director PEARL Network, NYU School of Medicine. New York, NY.
authors.forename: Frederick
authors.initials: F
authors.lastname: Naftolin
authors.affiliation: PEARL Information Core Coordinator, New York University, College of Dentistry. New York, NY.
authors.forename: Ashley
authors.initials: A
authors.lastname: Grill
authors.affiliation: PEARL Executive Management Team, PEARL Coordinating Center Principal Investigator, EMMES Corporation, Rockville, Maryland.
authors.forename: Don
authors.initials: D
authors.lastname: Vena
authors.affiliation: Vice Dean of Research, and PEARL Executive Management Team, New York University, College of Dentistry, New York, NY.
authors.forename: Louis
authors.initials: L
authors.lastname: Terracio
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Mariko
authors.initials: M
authors.lastname: Hashimoto
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Matthew
authors.initials: M
authors.lastname: Buchholz
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Andrea
authors.initials: A
authors.lastname: McKinstry
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Diane
authors.initials: D
authors.lastname: Cannon
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Vincent
authors.initials: V
authors.lastname: Alfano
authors.affiliation: PEARL Clinical Research Associate, New York University, College of Dentistry. New York, NY.
authors.forename: Thalia
authors.initials: T
authors.lastname: Gooden
authors.affiliation: Professor, Department Oral & Maxillofacial Pathology, Radiology & Medicine, New York University College of Dentistry, New York, NY.
authors.forename: Anthony
authors.initials: A
authors.lastname: Vernillo
authors.affiliation: Director of NYU School of Medicine IRB. New York, NY.
authors.forename: Elan
authors.initials: E
authors.lastname: Czeisler