Research Design and Data Management

Catalog description

Major research design methodologies and data management. Interpretation of research design, organization of study charts and data, participant eligibility, and maintenance of screening/visit logs. Submission of adverse event forms. Overview of database structures, electronic data collection methods, and effective presentation of data in required reports. Tracking of investigational agents and preparation for audits and site visits by sponsors and/or regulators. Federal regulations governing clinical trials electronic data submissions and transmissions. Prerequisites: None.