CT: Data Management Systems for Sponsors of Clinical Trials
FPM-40218
This course is designed to assist clinical trials sponsors to design data capture methods, and to organize and manage clinical trial data collected from one or more investigative sites. Topics include data flow from site to sponsor; case report form (CRF) design, database structures; database management systems including validation, backup, security and electronic data capture (EDC) systems; data capture techniques, data transfer and uploads; data quality methods including data entry, data review and programmatic checking, CRF-to-database audit procedures; analysis-ready database procedures; patient confidentiality; and ICH Guidelines (21 CFR part 11).
Course Information
Course sessions
Section ID:
Class type:
Textbooks:
No textbook required.
Policies:
- No refunds after: 2/21/2026
Note:
Schedule:
| Date | Day | Start | End |
|---|---|---|---|
| 2/21/2026 | Sat | 8:00 a.m. | 2:00 p.m. |
| 2/28/2026 | Sat | 8:00 a.m. | 2:00 p.m. |
| 3/7/2026 | Sat | 8:00 a.m. | 2:00 p.m. |
| 3/14/2026 | Sat | 8:00 a.m. | 2:00 p.m. |
Instructor: Sharon Rittenhouse
Working for a large Contact Research Organization (CRO) and now at a major biotech company
Sharon Rittenhouse brings over two decades of hands-on experience in clinical research and data management to the classroom. She currently serves as Senior Director of Clinical Data Management & Data Science at Artiva Biotherapeutics, where she leads teams that help bring new medicines through clinical trials and toward approval.
Her career spans leadership roles at companies like Edwards Lifesciences, Fate Therapeutics, and Allergan, where she has worked on everything from designing clinical databases to managing global teams and ensuring data quality for regulatory submissions. Sharon is passionate about making complex topics understandable and showing students how data plays a critical role in developing safe and effective treatments.
She holds a Bachelor of Science in Health Sciences from George Washington University and is a Certified Clinical Data Manager. Sharon has taught clinical data management courses at UC San Diego since 1999. Her teaching style is practical, engaging, and focused on preparing students for real-world careers in clinical research.
Whether you're exploring a career in healthcare, data science, or pharmaceuticals, Sharon offers a unique perspective that connects classroom learning with industry practice.
