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
The Center for Drug Evaluation and Research is what?
a) The division of the FDA that is responsible for drug approvals
b) The division of the EMEA that is responsible for drug approvals
c) The division of the PMDA that is responsible for drug approvals
d) None of the above
The EMEA only evaluates and supervises medications intended for use in humans.
a) True
b) False
MedDRA was developed by which of the following?
a) FDA
b) EMEA
c) PMDA
d) ICH
Which of the following can be a clinical trial sponsor?
a) Bella Pharmaceuticals, Inc.
b) Frederick A. Smith, MD
c) International Psoriasis Council
d) All of the above
Which of the following statements is true?
a) An SMO takes the responsibilities of a study sponsor
b) The government does not regulate contracts between SMOs and investigators
c) A CRO takes the responsibilities of a PI
d) All sponsors utilize the services of a CRO