A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure

Joan E. Adamo, Gerhard Bauer, Marlene Berro, Bruce K. Burnett, Karen A. Hartman, Lisa M. Masiello, Diane Moorman-White, Eric P. Rubinstein, Kathryn G. Schuff

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)279-284
Number of pages6
JournalAcademic Medicine
Volume87
Issue number3
DOIs
StatePublished - Mar 2012

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infrastructure
Health
health
Research
Compliance
Research Personnel
Clinical Trials
regulation
Needs Assessment
Drug and Narcotic Control
United States Food and Drug Administration
research practice
Documentation
Toxicology
documentation
personnel
monitoring
Safety
science

ASJC Scopus subject areas

  • Medicine(all)
  • Education

Cite this

Adamo, J. E., Bauer, G., Berro, M., Burnett, B. K., Hartman, K. A., Masiello, L. M., ... Schuff, K. G. (2012). A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. Academic Medicine, 87(3), 279-284. https://doi.org/10.1097/ACM.0b013e318244838a

A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. / Adamo, Joan E.; Bauer, Gerhard; Berro, Marlene; Burnett, Bruce K.; Hartman, Karen A.; Masiello, Lisa M.; Moorman-White, Diane; Rubinstein, Eric P.; Schuff, Kathryn G.

In: Academic Medicine, Vol. 87, No. 3, 03.2012, p. 279-284.

Research output: Contribution to journalArticle

Adamo, JE, Bauer, G, Berro, M, Burnett, BK, Hartman, KA, Masiello, LM, Moorman-White, D, Rubinstein, EP & Schuff, KG 2012, 'A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure', Academic Medicine, vol. 87, no. 3, pp. 279-284. https://doi.org/10.1097/ACM.0b013e318244838a
Adamo, Joan E. ; Bauer, Gerhard ; Berro, Marlene ; Burnett, Bruce K. ; Hartman, Karen A. ; Masiello, Lisa M. ; Moorman-White, Diane ; Rubinstein, Eric P. ; Schuff, Kathryn G. / A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure. In: Academic Medicine. 2012 ; Vol. 87, No. 3. pp. 279-284.
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