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.

Data Management & Informatics
Regulatory & Quality Sciences
Study & Site Management
Research & Study Conduct
Regulatory Science Symposium: Clinical Trials with Medical Devices Session 4: Quality at the Data Level (2019)

Topics

  1. Learning Objectives
  2. Case Studies
  3. Data Defined
  4. The Scientific Method
  5. GCP: Good Clinical Practices
  6. Quality Control
  7. Clinical Investigational Plan (CIP)
  8. Case Report Forms (CRFs)
  9. Clean data in = Clean data out
  10. Case Studies
  11. Quality Indicators
  12. Case Studies
  13. Principals of Good Documentation Practices (GDP)
  14. Summary
  15. Three Take Aways

Acknowledgement

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu 

Video Series

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NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.