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	DOWNLOADABLE DOCUMENTS Institutional Review Board (IRB) Audits - Are you prepared?  IRB Audits GUIDANCE ON REGULATIONS FDA - Food and Drug Administration  Main Web Site  Biologics  Drugs  Devices and Radiologics ICH - International Conference on Harmonization  www.ifpma.org/ich1.html NIH - National Institutes of Health  www.nih.gov OHRP - Office for Human Research Protection  http://ohrp.osophs.dhhs.gov  http://regsource.com HISTORY  Nuremberg Code  Belmont Report  Declaration of Helsinki, 2000 FEDERAL REGISTER (GCPs, GLPs and GMPs)  www.access.gpo.gov ORGANIZATIONS PhRMA -  Pharmaceutical Research & Manufacturing Association PRIMR -  Public Responsibility in Medicine and Research DIA -  Drug Information Association RAPS -  Regulatory Affairs Professional Society ACRP -  Association of Clinical Research Professionals SoCRA -  Society of Clinical Research Associates Brandt logos designed by Brandon Pennington