Complete the post-test online at www.cmeuniversity.com. On the navigation menu, click on "Find Post-tests by Course" and search by project ID 4962. Upon registering and successfully completing the post-test with a score of 70% or better and the evaluation, your certificate will be made available immediately. At this time, you will also have the opportunity to download a pdf of the post-test answer rationales.
Quiz
You reside in the United States and are about to start your first clinical trial, but the trial sponsor resides in France. Do the GCP Guidelines relate to you?
a) Yes
b) No
A clinical trial sponsor has contacted you about participating in a research project involving human subjects. According to the GCP Guidelines, in the United States, what must you do with the protocol before enrolling any subjects?
a) Pass it by your Study Coordinator
b) Have it approved by an IRB/REC
c) Give it to the CRO
d) Perform a spell check on it
You have been approached by Terra Pharmaceuticals about participating in a clinical trial on their new oral antibiotic in elderly patients. However, your practice is in a college town and your patients tend to be younger. You are concerned about meeting your enrollment goals. Does not meeting recruitment numbers violate the GCP Guidelines?
a) Yes
b) No
You are participating in a clinical trial and received a call today from Julia Terrance, the study monitor. According to the GCP Guidelines, what is her role?
a) Ensure that the rights and well-being of subjects are being protected
b) Ensure the reported data are accurate, complete, and verifiable
c) Verify that the trial is being conducted in compliance with the protocol and GCP
d) All of the Above
e) None of the Above
You are participating in a clinical trial of a new rheumatoid arthritis medication. One of the subjects experienced a severe rash that resulted in an overnight stay at the hospital. What should you do?
a) Mark that the event occurred on her case report form and include it in your monthly report the study sponsor.
b) Describe the event in a letter and mail it to the study sponsor
c) Call the study sponsor immediately upon learning of the event