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                                                                                                                                                                                                                                                                                                                27 U.S. Food and Drug Administration. August 2011, Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring, Rockville, MD. Available at: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf/. 28 Nievas O and Schefler S, July 2012. Trials in Latin America. Applied Clinical Trials. Available at: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/CRO%2FSponsor/Trials-inLatin-America/ArticleStandard/Article/detail/678142/. 29 Pan American Health Organization. Working Group on Good Clinical Practices: Documents. Available at: http://new.paho.org/hq/index.php?option=com_content&view=article&id=1588&Itemid=513 &limit=1&limitstart=1/. 30 The ASEAN Common Technical Dossier (ACTD) for the Registration of Pharmaceuticals for Human Use. Available at: http://www.moh.gov.bn/pharmacyservices/download/ASEAN%20Common%20Technical%20 Document%20%28ACTD%29.pdf/. 31 Open Clinical, 2012. Electronic medical records. Available at: http://www.openclinical.org/emr.html/.