GCP regulatory inspections: Lessons for Indian investigator sites
نویسندگان
چکیده
منابع مشابه
GCP inspections in Germany and Europe following the implementation of the Directive 2001/20/EC
BACKGROUND The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections - which affect study sites, laboratories, sponsors and contract research organizations (CRO) alike - make up an important part of these regulations. A common understanding...
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ژورنال
عنوان ژورنال: Perspectives in Clinical Research
سال: 2010
ISSN: 2229-3485
DOI: 10.4103/2229-3485.71776