Part 1. Google “Transforming a Clinician Into an Investigator”.  Click on the top Medscape.org hit.  Watch the FDA panel discussion (maybe slow to load, and you may have to create an account) and answer the questions below in your own words, together with your thoughts on the topic discussed.

• Discuss four challenges in conducting clinical trials today.
• Discuss four consequences of the clinical trial challenges and the effects on study personnel.
• Discuss the investigator responsibilities regarding “Clinical Trial Staff Training”.
• Discuss the 3 components to consider for trial supervision and oversight.

Part 2. Go to “Clinical Investigators – Disqualification Proceedings” at

http://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?&&

Pick 1 investigator whose last name starts with the same letter as yours and who was disqualified, preferably, after year 2000.  If no investigator’s last name matches, then settle for the closest letter to yours, or one disqualified before 2000. Discuss the specific violations committed by the investigator that led to the disqualification. 

You can let yourself get carried away and use up to 1.5 pages for this one. Arial11 pts, 1.15 spacing. No references needed for this homework.