Adaptation of Study Materials to country-specific requirements

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OverviewNowadays the majority of Clinical Trials are multi-national involving various countries, so the main (“master”, typically English) versions of Study Materials should be adapted as per country-specific requirements in order…

Читати даліAdaptation of Study Materials to country-specific requirements

Introduction to the Monitoring in Clinical Trials, Pre-Study Site Selection Visit

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OverviewAs per Good Clinical Practice (GCP) guideline “the purposes of trial monitoring are to verify that:a) The rights and well-being of human subjects are protected.b) The reported trial data are…

Читати даліIntroduction to the Monitoring in Clinical Trials, Pre-Study Site Selection Visit