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 sponsor of the trial you are participating in told you that they will be sending a monitor to your site once every 4 months. You really don’t want to be bothered and wonder if this frequency is allowed. You find out that which of the following is true?
a) Sponsors are allowed to audit a site only once a year
b) Sponsors are allowed to audit a site only in the beginning and then again at the end of a particular trial
c) Sponsors can set whatever frequency they feel is appropriate
You are a researcher in Argentina working on an important study of a new drug for rheumatoid arthritis that will be approved in the United States. Does the FDA have the right to inspect your facility?
a) Yes
b) No
An inspector from the FDA is coming tomorrow. What will she not be examining during the audit?
a) Patient consent forms
b) Data reports
c) Trial protocol
d) Patient adverse events
e) Your bedside manner
A man shows up at your door and says he is here to inspect your facility and conduct of the trial you are participating in. You should:
a) Ask for identification and documentation verifying his credentials.
b) Tell him you didn’t receive a phone call and he can’t come in.
c) Invite him in and give him access to all of your practice files.
An inspector from the EMEA during an audit told you that you were missing informed consent forms for half of the subjects. You know you are not missing these forms. What should you do?
a) Agree with the inspector and wait to respond to the final report
b) Ask the inspector to wait a minute and then produce the missing documents
c) Tell the inspector to look again because he must have missed the documents