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SOCRA CCRP Exam - Topic 2 Question 4 Discussion

A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:
A) Read and understood the investigator's brochure
B) Completed other relevant research projects
C) Confirmed that the site's SOPs are in place
D) Obtained malpractice insurance

SOCRA CCRP Exam - Topic 2 Question 4 Discussion

Actual exam question for SOCRA's CCRP exam
Question #: 4
Topic #: 2
[All CCRP Questions]

A study team is preparing to initiate a Phase II trial for a novel colon cancer therapy. By signing the Form FDA 1572, the investigator is certifying that the investigator has:

Show Suggested Answer Hide Answer
Suggested Answer: A

Form FDA 1572 is the ''Statement of Investigator'' for IND studies.

21 CFR 312.53(c)(1)(vi)(b): Requires investigators to ''read and understand the Investigator's Brochure.''

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B--D) are not part of 1572 requirements.

Correct answer: A.


21 CFR 312.53(c)(1)(vi)(b).

by Lawrence at Oct 02, 2025, 11:50 AM

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Ilda
7 months ago
Wait, do they really need malpractice insurance?
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Merri
7 months ago
I think C) is super important too.
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Caitlin
7 months ago
A) is definitely correct!
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Gilma
7 months ago
All of these are crucial for a smooth trial!
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Luther
7 months ago
B) seems a bit vague, not sure it’s necessary.
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Hassie
8 months ago
I’m a bit confused; I thought malpractice insurance was important for investigators, but I don’t recall it being part of the Form FDA 1572 requirements.
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Hassie
8 months ago
I feel like I’ve seen a similar question before, and it was definitely about understanding the investigator's brochure. So, I’m leaning towards A too.
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Katlyn
8 months ago
I remember something about SOPs being important, but I’m not sure if that’s what the form specifically certifies.
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Tegan
8 months ago
I think the answer might be A, since the Form FDA 1572 is all about ensuring the investigator is informed about the study.
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Shonda
9 months ago
I'm a bit confused by this question. Do I need to have completed other research projects (option B) or just the one we're working on? I'll have to double-check the study requirements to be sure.
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Rima
9 months ago
Easy peasy! Option A is the clear winner here. As long as I've read and understood the investigator's brochure, I'm good to go. The other options don't seem as directly relevant.
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Julian
9 months ago
Okay, I've got a plan - I'll start by confirming that the site's SOPs are in place (option C) to make sure everything is set up properly. Then I'll move on to reviewing the investigator's brochure.
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Ailene
9 months ago
Hmm, I'm a little unsure about this one. I know the investigator's brochure is important, but what about the other options? I'll need to review the study requirements more closely.
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Huey
9 months ago
This seems pretty straightforward - I'd focus on option A, making sure I've thoroughly reviewed the investigator's brochure and understand the details of the study.
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