Biotechnology

Navigating the FDA website.

Go to https://www.fda.gov/ICECI/default.htm

• Under “Navigate the Inspections, Compliance, Enforcement, and Criminal Investigations Section”, click on “Compliance Actions and Activities”
• Click on “Clinical Investigator – Disqualification Proceedings”.
  • What does NIDPOE stand for? Who does the FDA send it to?
  • What reasons are given for disqualifying a clinical investigator?
  • What activities are a disqualified investigator not permitted to do?
• On the same page, click on “Clinical Investigator – Disqualification Proceedings Database”.
• From the database, pick 2 investigators whose last name starts with the same letter as yours and who was disqualified and with NIDPOE issued after year 2000. If no investigator’s last name matches, then settle for the closest letter to yours, or one disqualified before 2000.
• Once you click on the investigator’s name, it will take you to the “Clinical Investigators – Disqualification Proceedings – Detail” page. You should be able to find 1-3 hyperlinks (Text or PDF) there that will take you to detailed descriptions of the disqualification proceedings.
• Discuss the violative actions committed by the investigators that led to their disqualification.