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: 8/9/2025
Note:
Schedule:
| Date | Day | Start | End |
|---|---|---|---|
| 8/9/2025 | Sat | 8:00 a.m. | 2:00 p.m. |
| 8/16/2025 | Sat | 8:00 a.m. | 2:00 p.m. |
| 8/23/2025 | 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 of Allergan Pharmaceuticals, has been involved with clinical trials for over 12 years, starting as a CRC for a small family practice and then moving to a local site management organization (SMO). She made the switch into data management working for a large contact research srganization (CRO) and now at a major biotech company.
