The Differences between Device and Drug Clinical Research- A Jeopardy Learning Game 2016 covers topics such as:
- Defining Device Research
- 510 K devices
- FDA approved devices
- Invitro Diagnostic Devices
- Humanitarian Device Exemptions
- Investigational Devices
- Defining Drug Research
- Investigational drugs
- FDA approved drugs
- Compassionate use
- Guidance governing drugs and devices
- Federal regulations governing drugs and devices
- How these studies are reviewed
- Combining devices and drugs into one study
- What are the regulations and guidance?
- What are the requirements?
The Differences between Device and Drug Clinical Research- A Jeopardy Learning Game 2016 brings together attendees from:
- Researchers
- Investigators
- Study Coordinators
- Research Staff
- Research Administrators
- Auditors
