DT_____________
Date_____________
DREAMS Team
May 2016
Congratulations on completing our DREAMS Team training!
Please select the best response for each item below.
1. Which of the following could be involved in the role of a research advocate?
a. Assisting in grant writing
b. Serving on an Institutional Review Board
c. Advising and assisting with study recruitment
d. Discussing with researchers what research is important to your community
e. All of the above
Where does each of the following potential research advocate activities fit
within the research process we discussed in class?
(Write the letter of the research stage next to the description of how to get
involved. Not all letters will be used.)
2. Write newsletter
articles or blog about
results
3. Provide input on
study design such as
barriers to
participation
4. Join a Data Safety
Monitoring Board
a.
b.
c.
d.
e.
f.
g.
Develop the study concept
Secure Funding
Prepare the study protocol
Create study procedure
Implement the study
Monitor the study
Analyze data and interpret
results
h. Disseminate Study
Information
i. FDA Review and Approval
j. Post approval studies
5. Serve as a peer
advocate during the
informed consent
process
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Match the definition to the correct research term:
6. Randomized trial
7. Controlled trial
a. The participant is not told which arm of
the trial he is on
b. One group of participants is given an
experimental drug, while another group is
given either a standard treatment for the
disease or an inactive treatment.
8. Placebo
c. Participants are assigned by chance to
one of two or more treatment arms of a
clinical trial
9. Blind
d. An inactive pill, liquid, or powder that has
no treatment value.
10. Which of the following BEST describes informed consent:
a. The participant signs a document describing study risks and procedures.
b. The participant is well informed about the research project, all of their
questions and concerns are addressed, and they agree to participate in the
study of their own free will.
c. The participant says they are willing to participate in the study.
d. The participant knows they will receive a $40 stipend and they really need
the money, so they agree to participate.
11. Which of the following could be a reasonable method to help make sure that
a study is performed ethically?
a. Researchers consult a cancer patient advocacy group before designing a
study affecting cancer patients.
b. The study is reviewed by an Institutional Review Board before it can begin.
c. The research is only performed if there are absolutely no risks involved.
d. A patient advocate serves as a member of the research team.
e. a, b, and d
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12. What is a p-value?
a. The probability of observing your result based on chance alone; a p-value
close to 1.00 would mean the result is probably due to chance, while a pvalue of close to zero means that the result is probably NOT due to chance.
b. The probability of observing your result based on chance alone; a p-value
close to 1.00 would mean the result is probably NOT due to chance, while a
p-value of close to zero means that the result is probably due to chance.
c. The probability that a result is true; a p-value close to 1.00 would mean the
result is probably true, while a p-value of close to zero means that the
result is probably NOT true.
d. The probability that a result is false; a p-value close to 1.00 would mean the
result is probably false, while a p-value of close to zero means that the
result is probably NOT false.
13. Aaron did a study to compare the walking speeds of individuals before and
after participating in a 3-week long yoga intensive. When Aaron ran statistics
comparing participants’ walking speeds before and after the yoga program,
he found a p-value of 0.001. How likely is it that Aaron’s results were due to
chance?
a. 0.001%
b. 0.1%
c. 10%
d. 100%
14. Given the p-value of 0.001 for Aaron’s yoga study, and normal cut-off
conventions, do you think that he can conclude that his results are probably
NOT due to chance? (Circle one)
Yes or No
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15. Which of the following could be the focus of a clinical research study:
a. Bladder incontinence
b. An exercise program
c. A new vaccine
d. All of the above
16. Which of the following studies could someone most likely participate in at
the same time as participating in a study evaluating the effects of
candesartan, a blood pressure medicine, on cognition?
a. A study evaluating the effect of daily brain exercises on cognition
b. A study evaluating the efficacy of a new blood pressure medication
c. A study involving a single visit where participants are tested for carriage of
the pneumococcus germ in their nose and throat
Match each phase of clinical research with its description:
17. Phase I
a. Confirm efficacy with expanded controlled
and uncontrolled trials
18. Phase II
a. Post-market evaluation: trials are run to
determine additional uses for an
approved drug or further study its safety
in large numbers of participants
19. Phase III
a. Trial designed to evaluate safety and
feasibility in healthy volunteers
20. Phase IV
a. Typically well-controlled and closely
monitored studies designed to evaluate
efficacy in patient population
FINISHED!!!!!
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Answer Key
1. e
2. h
3. c
4. f
5. e
6. c
7. b
8. d
9. a
10. b
11. e
12. a
13. b
14. Yes
15. d
16. c
17. c
18. d
19. a
20. b
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