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A roadmap for academic health centers to establish good laboratory practice-compliant infrastructure.
- Source :
-
Academic medicine : journal of the Association of American Medical Colleges [Acad Med] 2012 Mar; Vol. 87 (3), pp. 279-84. - Publication Year :
- 2012
-
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.
- Subjects :
- Animals
Humans
Laboratory Proficiency Testing legislation & jurisprudence
Quality Assurance, Health Care legislation & jurisprudence
Reference Standards
Research organization & administration
Research Support as Topic legislation & jurisprudence
Translational Research, Biomedical legislation & jurisprudence
United States
Academic Medical Centers legislation & jurisprudence
Academic Medical Centers standards
Government Regulation
Guideline Adherence legislation & jurisprudence
Guideline Adherence standards
Quality Assurance, Health Care standards
Research legislation & jurisprudence
Research standards
Translational Research, Biomedical standards
United States Food and Drug Administration legislation & jurisprudence
Subjects
Details
- Language :
- English
- ISSN :
- 1938-808X
- Volume :
- 87
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Academic medicine : journal of the Association of American Medical Colleges
- Publication Type :
- Academic Journal
- Accession number :
- 22373618
- Full Text :
- https://doi.org/10.1097/ACM.0b013e318244838a