- Learning Objectives
- Case Studies
- Data Defined
- The Scientific Method
- GCP: Good Clinical Practices
- Quality Control
- Clinical Investigational Plan (CIP)
- Case Report Forms (CRFs)
- Clean data in = Clean data out
- Case Studies
- Quality Indicators
- Case Studies
- Principals of Good Documentation Practices (GDP)
- Summary
- Three Take Aways
Regulatory Science Symposium: Clinical Trials with Medical Devices Session 4: Quality at the Data Level (2019)
In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.
Topics
Acknowledgement
Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu