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The ethical principle of beneficence is defined in which of the following

1. The ethical principle of beneficence is defined in which of the following
a. Belmont Report
b. Declaration of Helsinki
c. Nuremburg Code
d. International Commission on Harmonization

2. Effectiveness is defined as the intervention effect in an actual practice setting
a. True
b. False

3. A protocol is a detailed plan of execution that will describe:
a. Who is eligible to participate in the trial
b. Details about tests, procedures, medications, and dosages
c. The length of the study and what information will be gathered
d. All of the above

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4. Does a clinical trial have to be conducted in humans?
a. Yes
b. No

5. Does a clinical trial require a placebo group in the study design?
a. Yes
b. No

6. Does a clinical trial have to be prospective?
a. Yes
b. No

7. Determining dose is typically the goal of what type of study?
a. Phase I
b. Phase II
c. Phase III
d. Phase IV

8. Is an intervention a required component of a clinical trial?
a. Yes
b. No

9. Which of the following is an ESSENTIAL element of ethical research?
a. Valuable scientific question
b. Balance of risks and benefits
c. Subject selection based on locality
d. Independent review
e. A, B and C
f. A, B and D

10. Internal validity is the extent to which the observed difference in outcomes between the two comparison groups can be attributed to the intervention rather than the other factors.
a. True
b. False

11. Confounding is the distortion of the effect of one risk factor by the presence of another
a. True
b. False

12. Does a clinical trial have to be randomized?
a. Yes
b. No

13. For the purposes of human subjects protection “children” are persons who have not attained the legal age where research will be conducted
a. True
b. False

14. Investigators who solely provide previously collected coded human data or specimens are not involved in Human Subjects Research
a. True
b. False

15. The primary question drives the essential power and sample size calculations.
a. True
b. False

16. In a trial with negative results and a sufficient sample size, it may mistakenly conclude that the treatment under study made no difference
a. True
b. False

17. The group of individuals actually studied in the trial (the study sample) is selected from the study population.
a. True
b. False

18. Reducing heterogeneity in subject recruitment restricts generalizability?
a. True
b. False

19. The inclusion criteria are determined by the population selected so should be defined after selection of the study population.
a. True
b. False

20. Which method of randomization should be used to avoid imbalance in numbers assigned to each group
a. Coin flip
b. Simple randomization
c. Block randomization
d. Stratified randomization

21. The equivalency trial seeks to answer the question that the new intervention is no worse than the control.
a. True
b. False

22. A trial designed to detect whether a new intervention is better or worse than standard of care is referred to as a Superiority trial.
a. True
b. False

23. Which of the following are reasons for Masking in a clinical trial
a. Reduces bias in treatment decisions
b. Each group that is masked eliminates different source of bias
c. Important when there is a subjective outcome
d. A and B
e. A and C
f. All the above

24. For two comparison groups, A and B, which of the following patterns would be appropriate for a blocked design.
a. AB BA AABB ABAB AAABBB AB
b. AB BA AAABB BBBAA BAB
c. BA BBAA ABAB AA

25. Fixed allocation has equal allocation probabilities that do not change throughout the study while adaptive randomization strategies provide the opportunity to change the allocation probabilities during the active recruitment phase.
a. True
b. False

26. Randomization creates groups that are similar on unknown risk factors.
a. True
b. False

27. One method to improve group comparability is through stratification on important prognostic factors.
a. True
b. False

28. What type of trial allows a subject to serve as their own control?
a. Historical Control Design
b. Cross Over Design
c. Factorial Design

29. The members of the Data Safety Monitoring Committee must never be blinded to the treatment assignment.
a. True
b. False

30. In which type of study is the study subject and the investigator blinded to the treatment assignment:
a. Unmasked
b. Single
c. Double
d. Triple

31. In a single blind study; who is unaware of the treatment assignment?
a. Study Subject
b. Investigator
c. Pharmacy
d. Data Management Team

32. Which group is most likely to receive compensatory treatment?
a. Any study subject being paid to participate in a trial.
b. An investigator paid to recruit subjects.
c. Controls in an unblinded trial.
d. Study subjects that have experienced an adverse event.

33. If one fails to reject the null hypothesis when it is true, the decision is subject to a Type II error.
a. True
b. False

34. A one sided statistical test usually requires fewer subjects than a two sided test.
a. True
b. False

35. The assessment of comparability of baseline data is only required in nonrandomized trials.
a. True
b. False

36. Monitoring of recruitment should ONLY take place at the end of a clinical trial.
a. True
b. False

37. The non-biased group of people that will periodically review data for participant safety, study conduct, and progress, and who can make recommendations concerning continuation or cancellation of the trial is called:
a. Institutional Review Board
b. The Principle Investigator and Co-Investigators
c. Data Safety Monitoring Board

38. The definition of an adverse event is any treatment-related event, sign, or symptom that goes in an unwanted direction during a clinical trial.
a. True
b. False

39. Beta is the probability of a type I error and 1+beta is power.
a. True
b. False

40. The assessment of whether there is a “meaningful” difference on the primary outcomes of the study relates to efficacy?
a. True
b. False

41. A longer trial and follow up period usually results in better patient adherence.
a. True
b. False

42. When participants are entered into a trial at varying lengths of times and have varying lengths of follow-up, survival analysis is more appropriate than logistic regression.
a. True
b. False

43. In the curve above, what is the approximate survival rate of each treatment group at 6 years?
a. Treatment A = 100%, Treament B = 0%
b. Treatment A = 20%, Treatment B = 45%
c. Treatment A = 45%, Treatment B = 20%

44. If death is the event outcome in the attached curve, Treatment A had better results compared to Treatment B.
a. True
b. False

45. What advantage do Cox Proportional Models have over Kaplan-Meier estimates?
a. None, they’re too difficult
b. Ability to control for covariates
c. Produce prettier curves
d. Require less information to produce

46. Reasons for early termination of a trial include:
a. Serious adverse events
b. Inability to obtain significance at the end of the trial
c. PI moves to another institution
d. A and B

47. Suppose an investigator was conducting a study using the intent-to-treat principle. After 6 months, a participant enrolled in the study becomes ineligible due to nonadherence. This participant will be excluded in the final analysis of the study results.
a. True
b. False

48. Issues in closeout including data cleanup, storage, and dissemination should be defined in the protocol.
a. True
b. False

49. If a participant suffers an event after the final close-out, the investigator should count this as an event in the analysis.
a. True
b. False

50. A full data safety monitoring board is required in Phase I trials.
a. True
b. False

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