Discuss SOCRA CCRP Exam Topic 1 Question 13

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

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).

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21 comments · newest first

Truman 1 month ago

All options have merit, but B stands out for me.

Aleta 1 month ago

D is necessary for clarity on responsibilities.

Dominga 1 month ago

C seems less relevant for IRB submission.

Jeanice 2 months ago

Definitely B. Ethical to inform participants.

Vilma 2 months ago

A is important too. Budget transparency is key.

Marshall 2 months ago

I think B is crucial. Subjects need to know about compensation.

Stefania 2 months ago

All options have merit, but B stands out for me.

Julio 2 months ago

I agree with B. Ethical treatment of subjects is key.

Terina 2 months ago

D is essential. It outlines responsibilities clearly.

Nida 3 months ago

C might not be necessary for IRB. Focus on safety first.

Nina 3 months ago

A is important too. Budget transparency matters.

Gretchen 3 months ago

I think B is crucial. Subjects need to know compensation.

Elvera 3 months ago

I thought only the budget and compensation were necessary.

Detra 3 months ago

Wait, do we really need the clinical trial agreement for IRB?

Rossana 4 months ago

Not sure why the marketing plan is relevant here.

Teddy 5 months ago

I think the compensation details are crucial too.

Shawnee 5 months ago

Definitely need the itemized study budget!

Jesusa 6 months ago

The drug development plan sounds familiar, but I’m not confident if it’s something the IRB needs to see for a Phase IV study.

Tomas 6 months ago

I feel like the clinical trial agreement is relevant, but I can't recall if it’s mandatory for the IRB submission.

Frankie 6 months ago

I remember discussing compensation for subjects in class; it seems like that should definitely be included.

Bulah 6 months ago

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

SOCRA CCRP Exam - Topic 1 Question 13 Discussion