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PRACTICE QUESTIONS FOR SOCRA EXAM
2025: REAL VERIFIED QUESTIONS & CORRECT
ANSWERS| PACK OF EXCELLENCE| THE
ULTIMATE KEY TO YOUR SUCCESS.
1. What does 21 CFR54 deal with? - correct answer -
2. What is the FDA form 3454? - correct answer -
3. What is a person or an organization (commercial, academic, or
other) contracted by the sponsor of a clinical trial to perform
one or more trial-related duty and function? - correct answer -
4. A(n) ____ is an investigation or marked product, or placebo,
used as a reference in a clinical trial. - correct answer -
5. What is 21 CFR 50/51 subpart D? - correct answer -
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6. The international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that
involve the participation of human subjects is known as -
correct answer -
7. What is 21 CFR 50.54 Subpart D? - correct answer -
8. What is 21 CFR50 subpart D? - correct answer -
9. The Code of Federal regulations that applies to the protection
of human subjects is - correct answer -
10. What are the three fundamental ethical principals for human
subjects research - correct answer - 1. respect for persons
11. 2. beneficience
12. 3. justice
13. A(n) ______ can be any unfavorable and unintended sign
(including an abnormal laboratory finding), symptom, or
disease temporally associated with the use of a medicinal
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(investigational) product, whether or not related to the
medicinal (investigational) product. - correct answer -
14. What is 21 CFR50 subpart B? - correct answer -
15. The FDA form 483 is used for: - correct answer -
16. The IRB may, for some or all subject, waive the requirement
hat the subject, or the subjects legally authorized
representative, sign a written consent form if it finds that the
research presents more than minimal risk of harm to subjects
and involves no procedures for which written consent is
normally required outside the research context - correct answer
- a. true
17. b. false
18. Which of the following is 21 CFR 56.106 Subpart B? -
correct answer -
19. Which of the following are necessary to satisfy 21 CFR50.24
subpart B? - correct answer -
PRACTICE QUESTIONS FOR SOCRA EXAM
2025: REAL VERIFIED QUESTIONS & CORRECT
ANSWERS| PACK OF EXCELLENCE| THE
ULTIMATE KEY TO YOUR SUCCESS.
1. What does 21 CFR54 deal with? - correct answer -
2. What is the FDA form 3454? - correct answer -
3. What is a person or an organization (commercial, academic, or
other) contracted by the sponsor of a clinical trial to perform
one or more trial-related duty and function? - correct answer -
4. A(n) ____ is an investigation or marked product, or placebo,
used as a reference in a clinical trial. - correct answer -
5. What is 21 CFR 50/51 subpart D? - correct answer -
, Page | 2
6. The international ethical and scientific quality standard for
designing, conducting, recording and reporting trials that
involve the participation of human subjects is known as -
correct answer -
7. What is 21 CFR 50.54 Subpart D? - correct answer -
8. What is 21 CFR50 subpart D? - correct answer -
9. The Code of Federal regulations that applies to the protection
of human subjects is - correct answer -
10. What are the three fundamental ethical principals for human
subjects research - correct answer - 1. respect for persons
11. 2. beneficience
12. 3. justice
13. A(n) ______ can be any unfavorable and unintended sign
(including an abnormal laboratory finding), symptom, or
disease temporally associated with the use of a medicinal
, Page | 3
(investigational) product, whether or not related to the
medicinal (investigational) product. - correct answer -
14. What is 21 CFR50 subpart B? - correct answer -
15. The FDA form 483 is used for: - correct answer -
16. The IRB may, for some or all subject, waive the requirement
hat the subject, or the subjects legally authorized
representative, sign a written consent form if it finds that the
research presents more than minimal risk of harm to subjects
and involves no procedures for which written consent is
normally required outside the research context - correct answer
- a. true
17. b. false
18. Which of the following is 21 CFR 56.106 Subpart B? -
correct answer -
19. Which of the following are necessary to satisfy 21 CFR50.24
subpart B? - correct answer -
