Exam (elaborations)
ACRP CCRC Clinical Trials Exam Updated Questions and Answers (2024/2025) (Verified Answers)
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ACRP CCRC Clinical Trials Exam Updated Questions and Answers (2024/2025) (Verified Answers)
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ACRP CCRC Clinical Trials Exam.pdf file:///C:/Users/HP/Desktop/New%20folder%20(4)/ACRP%20CCRACRP CCRC Clinical Trials Exam
Questions & Answers
1. Research means a systematic investigation, including research develop-
ment, testing and evaluation, designed to develop or contribute to general-
izable knowledge.
Answer True
2. Minimal risk means that the probability and magnitude of harm or discom-
fort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests.
Answer True
3. What is UWF's Federal wide Assurance number?
Answer FWA00002657
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,ACRP CCRC Clinical Trials Exam.pdf file:///C:/Users/HP/Desktop/New%20folder%20(4)/ACRP%20CCR
4. How many members must an IRB include at minimum?
Answer 5
5. IRB records must be kept for years after a study has ended.
Answer 3
6. Advertisements designed to recruit study participants do not require IRB
review.
Answer False
7. Study activities may begin as soon as a subject consents as long as the
researcher has verbal approval from the IRB.
Answer False
8. CFR 21 Part 50, CFR 45 part 46, and ICH E6 GCP generally provide similar
guidance for IRB's
Answer True
9. If additional information regarding the safety of an investigational product
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becomes available to the investigator after he receives IRB approval and has
enrolled subjects, he does not need to provide this safety information to the
IRB
Answer False
10. If you are the principal/primary investigator of an UWF IRB approved
research project and you want to add a new site to your project, you must
Answer complete an IRB project Amendment Request Form.
11. Researchers are only required to gain approval from one IRB regardless if it
is with their own institution or not.
Answer False
12. A research proposal can be denied under expedited IRB review if the sole
board member conducting the review does not think it is a significant
contribution to science
Answer False
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