Johns Hopkins University 3 credits Epidemiology
Expands on the concepts presented in Introduction to Clinical Trials (340.645) and Clinical Trials: Procedures, Design, and Interpretation of Results (340.861) by elaborating on clinical trial analytical considerations and design options in both the regulatory, clinical, and public health context. Details design considerations, budgeting and recruitment strategies, communication of clinical trial results, and reporting responsibilities. Navigates the financial and administrative aspects of trial planning, creates a comprehensive recruitment strategy, applies necessary trial components and considerations for regulatory submissions, describes the roles and responsibilities of a data/clinical coordinating center, and communicates and interprets the results of a trial.
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