High-quality clinical data are at the heart of a successful clinical trial. If the data are not complete or do not reflect the actual reported results, the analysis and the conclusions drawn from that analysis may not be reliable. This course provides clinical trial personnel a solid understanding of the steps involved in clinical data management from study site data collection through data extraction for analysis.

Topics include:

• A planned approach to clinical data management
• Basic design and specification of the database and cleaning rules
• Required documentation, standard operating procedures (SOPs), and quality control
• Compliance with FDA/ICH guidelines
• Working with other clinical groups and external contract research organizations (CROs)
• Using electronic data capture (EDC)
• Data security and confidentiality

At the conclusion of the course, students will write their own data management plan. No previous data management experience is necessary although familiarity with Microsoft Excel is required.

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.