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- Not categorized 0%
- Audits 0%
- Introduction to Clinical Study Designs and Terminology 0%
- Managing a Multicenter RCT: Lessons Learned 0%
- Phases of a Clinical Trial 0%
- Preparing for Your Study: Using the MOP and Study Protocol 0%
- Protocol Deviations: Overview 0%
- Research Protocol Development: What is a Protocol and How Does It Differ Among Mechanisms? 0%
- Research Record-Keeping: Essential Practices Questions 0%
- Research Record-Keeping: Essential Practices Questions 0%
- Understanding Pediatric Assent and Ethical Considerations in Conducting Clinical Research 0%
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Question 1 of 26
1. Question
Match the study type with the correct description.
Sort elements
- Longitudinal study
- Retrospective study
- Prospective study
- Cross-sectional study
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An investigator follows a group exhibiting a condition or outcome over an extended period of time, usually years.
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An investigator collects data from a past event.
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An investigator follows a group of participants that does not exhibit the condition or outcome at the start of the study over time. Comparisons are then made within the group and between participants who develop the outcome and those who do not.
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An investigator looks at "snapshot" of the disease characteristics in a defined population as a specific point in time.
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Question 2 of 26
2. Question
Match the term to the correct definition.
Sort elements
- Subject
- Equivalence
- Research question
- Non-inferiority intervention
- Arm
- Superiority intervention
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Patient or participant.
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Both arms are equally effective.
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Serves as a basis for a study design and must advance knowledge or practice.
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One group is not as good as the other but not enough to make a difference.
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Sample or group of participants.
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Detecting a difference between groups, treatments, or study arms.
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Question 3 of 26
3. Question
Intervention studies differ from observational studies because they (select all that apply):
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Question 4 of 26
4. Question
A Phase I Trial assesses how well a drug or procedure can be tolerated in humans and/or determines a reasonable dose or technique.
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Question 5 of 26
5. Question
A Phase II Trial assesses effectiveness in comparison to standard treatment or placebo.
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Question 6 of 26
6. Question
Key sections of a protocol include which of the following:
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Question 7 of 26
7. Question
The Discussion of Results section in a protocol typically receives close scrutiny from the IRB.
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Question 8 of 26
8. Question
The MOP typically is more current than the study protocol and its information supersedes the protocol.
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Question 9 of 26
9. Question
The Protocol should contain all of the following elements EXCEPT:
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Question 10 of 26
10. Question
The Protocol is what the researcher needs to know about the study, while the MOP is a handbook that details a study’s conduct and operations.
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Question 11 of 26
11. Question
The MOP contains all of the following parts EXCEPT:
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Question 12 of 26
12. Question
The cornerstone of all clinical research is which of the following:
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Question 13 of 26
13. Question
Random audits ensure compliance with protocol, GCP, laws, and regulations.
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Question 14 of 26
14. Question
The two conditions for audits include which of the following EXCEPT:
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Question 15 of 26
15. Question
At the site level, who is ultimately responsible for acceptable conduct of research?
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Question 16 of 26
16. Question
It’s recommended to submit the protocol to the study team and Data Safety Monitor Committee 9DSMC) for review and approval many times before the final submission.
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Question 17 of 26
17. Question
All of the following are helpful tips for projecting and mitigating risk: 1. when developing the protocol, be precise and stay broad where you can; 2. include best practices in the MOP; 3. pivot if necessary if it does not impact the quality of the science.
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Question 18 of 26
18. Question
Different classifications or levels of protocol deviations include:
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Question 19 of 26
19. Question
Match the term to the correct example.
Sort elements
- Continuing non-compliance
- Violation
- Deviation
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The study PI repeatedly takes blood samples from study participants before obtaining signed, informed consent.
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A blood sample as taken before study participant gave signed, informed consent.
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A blood sample was not taken from the subject at the beginning of the study as specified in the protocol.
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Question 20 of 26
20. Question
Which of the following is NOT a consequence of a repeated protocol deviation?
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Question 21 of 26
21. Question
If a specific deviation occurs more than once during the same study, you should:
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Question 22 of 26
22. Question
A pediatric assent document should describe the research protocol, as well as explain that the minor’s participation is voluntary.
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Question 23 of 26
23. Question
According to the American Academy of Pediatrics, children ages 5 and older are psychologically capable of providing assent to voluntarily participate in a research study.
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Question 24 of 26
24. Question
Comprehension scores are better when participants are given medical information that contains both illustrations and text.
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Question 25 of 26
25. Question
Proper informed consent, protocol adherence or general regulatory adherence cannot be verified without valid data from good records.
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Question 26 of 26
26. Question
Source documents include all of the following Except: