Learn essential skills for managing and validating high-quality clinical trial data.
Course Description
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
- 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
Professional Credit
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 20 contact hours
- Final Coursework Due Work due after the last course meeting.
Course has been postponed from the original start date. See full schedule below.
This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each class meeting.
No meeting November 27, 2025. To see all meeting dates, click "Full Schedule" below.
Electronic Course Materials: You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
