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Clinical Trials: • Interventional vs. non-interventional studies • Trials involving medicinal products / Phases of drug development • Study objectives • Typical study designs • Randomization, blinding, study documentation, sample size determination Good Clinical Practice (GCP) and Research Ethics: • Ethical principles for research • History of clinical research ethics (incl. case studies) • Good Clinical Practice guidelines / legal framework • Roles, tasks and responsibilities in clinical studies as defined by ICH-GCP • Patient information and consent • Clinical trial application / Ethics committees / Competent authorities • Scientific requirements and practical implementation issues • Quality management in clinical trials • Patient information and consent • Data collection and handling / Statistical planning and analysis • Adverse events and safety reporting |