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 have the x-rays from the subjects in the clinical trial that you just completed. Should you throw them away?
a) Yes
b) No
You bought a dozen boxes of ballpoint pens specifically for the clinical trial. Should you keep the receipts?
a) Yes
b) No
You are looking through all of the paperwork involved in a clinical trial for a new weight loss drug for which you have agreed to participate. One of the forms is Form 1572 from the FDA. When do you need to submit this form to the study sponsor?
a) Before the beginning of the trial
b) Before the first dose of medication is dispensed
c) Before the end of the trial
d) Before the data are published
You are writing the first draft of a manuscript of the data from the latest clinical trial that you helped conduct. You want to discuss the adverse events experienced by one particular patient, Mary DeStefan, but, because the trial was conducted in the United States, HIPAA dictates that you must do what?
a) First report the adverse events to the FDA
b) Submit a form to the publisher that states that the sponsor is aware of the adverse events experienced by Mary
c) Remove Mary’s name and identify her as Patient 71
d) Nothing
You are explaining to your new study coordinator why it is important to follow proper documentation practices. Which of the following do you tell him?
a) Because FDA Form 1572 says so
b) It may help you if a study subject brings a lawsuit against the institution
c) Improper or incomplete documentation is ethically irresponsible
d) All of the above