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SOCRA CCRP Exam - Topic 3 Question 11 Discussion

In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?
C) The reviewing IRB/IEC
A) The clinical investigator
B) A data safety monitoring board
D) The medical monitor

SOCRA CCRP Exam - Topic 3 Question 11 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 11
Topic #: 3
[All CCRP Questions]

In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?

Show Suggested Answer Hide Answer
Suggested Answer: C

Minimal risk determination is a regulatory function of the IRB/IEC.

45 CFR 46.102(j): Defines minimal risk as harm or discomfort not greater than those ordinarily encountered in daily life.

45 CFR 46.109(a): The IRB has authority to approve, require modifications, or disapprove research, including assessment of risk level.

Investigators may propose a study as minimal risk, but only the IRB/IEC can formally classify it.

This ensures independent, unbiased evaluation of risk, protecting participants from investigator or sponsor bias.


by Lavelle at Mar 09, 2026, 01:09 AM

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Britt
5 hours ago
Wait, are we sure it's not the medical monitor?
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Xuan
5 days ago
I thought it was the clinical investigator?
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Kendra
11 days ago
It's definitely the reviewing IRB/IEC!
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Rueben
16 days ago
This seems too straightforward; I have my doubts about it.
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Deeanna
2 months ago
Wait, are you sure? I thought the medical monitor had a say too.
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Carri
2 months ago
I agree, the IRB/IEC has to approve it first.
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Shayne
2 months ago
I thought it was the clinical investigator?
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Phil
3 months ago
It's definitely the reviewing IRB/IEC!
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Jesusita
3 months ago
I feel like the clinical investigator might have some input, but it seems like the IRB would have the final say.
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Theodora
3 months ago
I practiced a similar question, and I think it was about the IRB making the final call on minimal risk criteria.
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Rickie
3 months ago
I’m not entirely sure, but I remember something about the data safety monitoring board being involved in risk assessments.
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Anastacia
3 months ago
I think the reviewing IRB/IEC is the right answer since they evaluate the ethical aspects of studies.
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Lynna
3 months ago
I remember that the data safety monitoring board usually oversees the safety of the study, but I don’t think they make the initial risk determination. So I’m also thinking it’s C.
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Truman
4 months ago
I’m a bit confused. I thought the clinical investigator had some responsibility in assessing risk, but I guess it’s more about the IRB?
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Ling
4 months ago
I feel like I’ve seen a question like this before, and it was about the IRB being responsible for determining risk levels. So I’m leaning towards C as well.
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Alpha
4 months ago
I think the answer might be C) The reviewing IRB/IEC, but I’m not entirely sure. I remember something about their role in assessing risk.
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