UPIRSO Quiz
You are the coordinator for a Phase II hypertension study and a patient was given his first dose of the experimental drug along with his existing blood pressure medication because he met criteria as an uncontrolled hypertensive patient after failing all currently accepted therapies. The subject went home after the required monitoring period and at the next appointment it is noted that he is jaundiced. Liver problems were not anticipated per any protocol documentation.
1. What is your first step?
- a. Report the AE immediately to the IRB
- b. Report the finding immediately to the PI
- c. Report the AE to the Sponsor
- d. Report the AE to the FDA
- e. All of the above
- f. None of the above
NOT THE BEST ANSWER
You answered C. While most serious adverse events will require reporting to the sponsor (refer to your data and safety monitoring plan) there is a better answer in the selections above.
Click on a different answer above to try again.
- HINT: The question asks for your "first step".
- Now try another response above.