Deal of The Day! Hurry Up, Grab the Special Discount - Save 25% - Ends In 00:00:00 Coupon code: SAVE25
Welcome to Pass4Success

- Free Preparation Discussions
Mail Us support@pass4success.com
Location US
Mob_nav_barsMENU

SOCRA CCRP Exam - Topic 1 Question 13 Discussion

Which of the following should a clinical investigator include in a submission to an IRB/IEC for a Phase IV drug study?
B) The amount of payments and compensation to subjects
A) The itemized study budget
C) The drug development and marketing plan
D) The investigator's clinical trial agreement with the sponsor

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?

Show Suggested Answer Hide 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

Limited Time Offer

25%

Off

Get Premium CCRP Questions as Interactive Web-Based Practice Test or PDF

Contribute your Thoughts:

0/2000 characters
Submit Cancel
Gretchen
5 hours ago
I think B is crucial. Subjects need to know compensation.
upvoted 0 times
...
Elvera
5 days ago
I thought only the budget and compensation were necessary.
upvoted 0 times
...
Detra
11 days ago
Wait, do we really need the clinical trial agreement for IRB?
upvoted 0 times
...
Rossana
16 days ago
Not sure why the marketing plan is relevant here.
upvoted 0 times
...
Teddy
2 months ago
I think the compensation details are crucial too.
upvoted 0 times
...
Shawnee
2 months ago
Definitely need the itemized study budget!
upvoted 0 times
...
Jesusa
3 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.
upvoted 0 times
...
Tomas
3 months ago
I feel like the clinical trial agreement is relevant, but I can't recall if it’s mandatory for the IRB submission.
upvoted 0 times
...
Frankie
3 months ago
I remember discussing compensation for subjects in class; it seems like that should definitely be included.
upvoted 0 times
...
Bulah
3 months ago
I think the budget might be important, but I'm not entirely sure if it’s required for the IRB submission.
upvoted 0 times
...

Save Cancel