SOCRA CCRP Exam - Topic 2 Question 4 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 4
Topic #: 2

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:

ARead and understood the investigator's brochure

BCompleted other relevant research projects

CConfirmed that the site's SOPs are in place

DObtained malpractice insurance

Show Suggested 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

5 months ago

Wait, do they really need malpractice insurance?

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Merri

5 months ago

I think C) is super important too.

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Caitlin

5 months ago

A) is definitely correct!

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Gilma

6 months ago

All of these are crucial for a smooth trial!

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Luther

6 months ago

B) seems a bit vague, not sure it’s necessary.

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Hassie

6 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

6 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

7 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

7 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

7 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

7 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

7 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

8 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

8 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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