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
THIS IS THE BEST ANSWER
RATIONALE: You answered B. While there are several reporting requirements (refer to your data and safety monitoring plan) the best first step as the coordinator is to notify the treating doctor (assumed in this case to be PI).