Regulatory Science Symposium: Clinical Trials with Medical Devices Session 5: Medical Device Feasibility Clinical Trials – SetPoint Medical Case Study (2019)

In this series, we will discuss considerations, regulations and resources to utilize when conducting clinical trials with medical devices.

Regulatory & Quality Sciences
Study & Site Management
Research & Study Conduct
Regulatory Science Symposium: Clinical Trials with Medical Devices Session 5: Medical Device Feasibility Clinical Trials – SetPoint Medical Case Study (2019)

Topics

  1. SetPoint Medical Overview
  2. SetPoint System
  3. Feasibility Study Design
  4. Key Objectives
  5. Study Stages
  6. Site Selection and Activation
  7. Investigator and Study Staff Training
  8. Screening and Enrollment
  9. Monitoring
  10. Study Closeout

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.