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 are planning to participate in your first clinical trial. You know you are going to need help. Which of the following positions should you hire first?
a) Dedicated receptionist
b) Laboratory technician
c) Another physician
d) Study coordinator
The clinical trial protocol you are reviewing requires subjects to come into the clinic for 1 day to take a pill and then have their blood pressure monitored and an ECG taken every hour for 6 hours. The subjects will be evaluated as they are enrolled; thus, not everyone will be evaluated on the same day, but you may have 2 or 3 subjects on any given day. Which of the following is the best situation for performing the assessments?
a) Have a dedicated examination room; train one nurse to take the assessments and record the results; and designate part of the waiting room for the subjects by putting up temporary screens so they are comfortable all day
b) Use whichever examination room is available; take time away from seeing your regular patients to perform the assessments; and send the patients home in between evaluations
c) Both are equally viable alternatives
The protocol states that the investigational compound must be refrigerated, but your practice’s refrigerator is already full. What do you do?
a) Take medications that are currently in the refrigerator and store them in the closet
b) Buy a new refrigerator to store the investigational compound
c) Have the sponsor only send 1 dose of the investigational compound at a time
d) Bring the investigational compound home and store it in your family’s refrigerator
You’ve just finished the final assessment on the last subject enrolled at your site. However, you’ve been too busy to enter all of the raw data into the program that the sponsor supplied. Which of the following is the best option for you, considering the sponsor has requested the information by the end of the week?
a) Try to do it yourself in between patients
b) Convince one of the nurses in your office to do it after hours
c) Hire a data entry person on a temporary basis
d) Give the data in hard copy to the sponsor
You completed a small clinical trial about a month ago, but the raw data collection sheets have been taking up space in a back room that you want to convert into another exam room. What do you do with all of the papers?
a) You throw them out because the trial is over
b) You bring them home and store them in a filing cabinet in your attic
c) You send them to the study sponsor
d) You send them to the FDA to back up the new drug application (NDA)