February 2024 SOCRA Source Journal - Journal - Page 24
SELF STUDY ANSWER KEY
Ethical Considerations for Clinical Investigations of Medical
Products Involving Children
Part 2
ANSWERS
1. b. False (Section IV/B.1)
2. e. Only a. and b. (Section IV/B)
3. b. False (Section IV/C)
4. e. Only a. and c. (Section IV/C.1)
5. b. False (Section IV/C)
6. a. Minor increase over minimal risk/minor increase of over minimal risk (Section IV/B.1)
7. b. False (Section IV/A)
8. c. 50.54 (Section IV/C.1)
9. a. True (Section IV/B.1)
10. b. False (Section IV/B.2)
24
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