SOCRA CCRP Exam - Topic 1 Question 13 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 13
Topic #: 1

[All CCRP Questions]

Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?

AThe itemized study budget

BThe amount of payments and compensation to subjects

CThe drug development and marketing plan

DThe investigator's clinical trial agreement with the sponsor

Show Suggested Answer

Suggested Answer: B

For IRB/IEC submissions, investigators must disclose subject-related information that may impact voluntariness or fairness of participation.

21 CFR 56.111(a)(3): The IRB must ensure that subject selection is equitable.

21 CFR 50.25(a)(3): Requires disclosure of ''any compensation and/or medical treatments available if injury occurs.''

ICH E6(R2) 4.8.10(n): Informed consent should describe ''any compensation and/or reimbursement to subjects.''

Thus, compensation amounts must be reviewed by IRB/IEC to ensure they are not coercive or excessive. Budgets (A), marketing plans (C), and contracts (D) are administrative and not part of IRB submission requirements.

Correct answer: B (The amount of payments and compensation to subjects).

21 CFR 50.25(a)(3).

ICH E6(R2), 4.8.10(n).

by Bernadine at Apr 08, 2026, 02:17 AM

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Bulah

5 days ago

I think the budget might be important, but I'm not entirely sure if it’s required for the IRB submission.

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