title: A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.
abstract: Prior to human clinical trials, nonclinical safety and toxicology studies are required to demonstrate that a new product appears safe for human testing; these nonclinical studies are governed by good laboratory practice (GLP) regulations. As academic health centers (AHCs) embrace the charge to increase the translation of basic science research into clinical discoveries, researchers at these institutions increasingly will be conducting GLP-regulated nonclinical studies. Because the consequences for noncompliance are severe and many AHC researchers are unfamiliar with Food and Drug Administration regulations, the authors describe the regulatory requirements for conducting GLP research, including the strict documentation requirements, the necessary personnel training, the importance of study monitoring, and the critical role that compliance oversight plays in the process. They then explain the process that AHCs interested in conducting GLP studies should take before the start of their research program, including conducting a needs assessment and a gap analysis and selecting a model for GLP compliance. Finally, the authors identify and analyze several critical barriers to developing and implementing a GLP-compliant infrastructure at an AHC. Despite these challenges, the capacity to perform such research will help AHCs to build and maintain competitive research programs and to facilitate the successful translation of faculty-initiated research from nonclinical studies to first-in-human clinical trials.
authors.affiliation: Office of Regulatory Support, Clinical and Translational Science Institute, University of Rochester Medical Center, New York, USA. Joan_Adamo@urmc.rochester.edu
authors.forename: Joan E
authors.initials: JE
authors.lastname: Adamo
authors.forename: Gerhard
authors.initials: G
authors.lastname: Bauer
authors.forename: Marlene
authors.initials: M
authors.lastname: Berro
authors.forename: Bruce K
authors.initials: BK
authors.lastname: Burnett
authors.forename: Karen A
authors.initials: KA
authors.lastname: Hartman
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Masiello
authors.forename: Diane
authors.initials: D
authors.lastname: Moorman-White
authors.forename: Eric P
authors.initials: EP
authors.lastname: Rubinstein
authors.forename: Kathryn G
authors.initials: KG
authors.lastname: Schuff
mesh_terms: D000046:Academic Medical Centers / Q000331:legislation & jurisprudence* / Q000592:standards*; D000818:Animals; D033161:Government Regulation; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D059021:Laboratory Proficiency Testing / Q000331:legislation & jurisprudence; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000592:standards*; D012015:Reference Standards; D012106:Research / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards*; D012109:Research Support as Topic / Q000331:legislation & jurisprudence; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*