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.
At the conclusion of the course, you should be able to
- List the common tasks undertaken as part of clinical data management.
- Understand the details and variations associated with each of those tasks.
- Write a data transfer specification for collecting lab data.
- Write a quality specification and query message for cleaning Case Report Form (CRF) data.
- Define the deliverables and responsibilities when working with Contract Research Organizations (CRO).
- Write a data management plan.
- 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
Working knowledge of:
Additional InformationPlease review section notes to view the full schedule.
Professional CreditCA BRN/LVN Credit--Provider #CEP13114.
Have a question about this course?
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
Here are ways to pay for your education.
This course is related to the following programs:
Estimated Cost: TBD
Course Availability Notification
Please use this form to be notified when this course is open for enrollment.