Assignment

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

1. Discuss four challenges in conducting clinical trials today.
2. Discuss four consequences of the clinical trial challenges and the effects on study personnel.
3. Discuss the investigator responsibilities regarding “Clinical Trial Staff Training”.
4. 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?sd=clinicalinvestigatorsdisqualificationproceedings&previewMode=true&displayAll=true

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. Take note of your notable investigator violations as I will be asking some of you to write the violations on the board.