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We hereby confirm that the participant has successfully completed the KI PhD course, "Quality Assurance of Clinical Research" (K2F5580) including GCP (Good Clinical Practice). This course corresponds to 1,5 ECTS credits. Topics covered: ICH-GCP including Glossary, Ethical Review Board, Investigator's Responsibilities, Sponsor's Responsibilities, Clinical Trial Protocol, Investigator's Brochure, and Essential Documents for the Conduct of a Clinical Trial. European and National Legislation. Risk-analysis case studies.
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