Fall Hours • COVID-19 Update
The Silicon Valley Campus is open 4–9:30 p.m. on Monday–Friday and 8 a.m.–5 p.m. on Saturday.
All campus visitors must be vaccinated, wear a mask, & submit a COVID symptom check. Visit our COVID page for updates.
Course
Clinical Data Management | CTDM.X400
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.
Have a question about this course?
ENROLL EARLY!
- Save your seat and help us confirm course scheduling. Enroll at least seven days before your course starts.
- ACCESSING CANVAS—Learn more about accessing your course on Canvas in our FAQ section.
This course is related to the following programs:
Course Availability Notification
Please use this form to be notified when this course is open for enrollment.
Contact Us