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Examples
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As Lead CRA you will be responsible for overseeing all monitoring activities on a project level for multinational Phases III, IV and Post-Market Surveillance Programs and Registries including interventional and noninterventional studies, post-authorisation safety studies
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Inspections take place at both sets standards for the protection of study sub - sponsor's facilities and clinical trial sites. jects, including especially vulnerable groups All research involving human subjects (apart such as children and incapacitated adults; from wholly noninterventional, observational stu - dies), including academic research and Clinical requires every MS to have a central governing Pharmacology studies in healthy volunteers, fall body that oversees ethics committees; within the scope of the Directive.
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(both patients and normal volun - The Clinical Trials Directive requires the inte - teers) fall within its remit, unless the trial is merely gration of the GCP guidelines into the national law observational and noninterventional.
Recently Uploaded Slideshows martins0105 2009
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