Discuss SOCRA CCRP Exam Topic 1 Question 16

The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?

AThe sponsor failed to submit an accurate annual report of the study to the FDA

BThe reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study

CAn investigator failed to submit safety reports to the FDA

DThe FDA issued a clinical hold, and 30 days have elapsed

Suggested Answer: D

The FDA has authority to impose clinical holds and terminations on IND studies when subject safety is at risk.

21 CFR 312.44(b)(1): ''The FDA may propose to terminate an IND if it finds that human subjects would be exposed to an unreasonable and significant risk of illness or injury.''

21 CFR 312.42(e): ''If an IND is placed on clinical hold and the deficiencies have not been adequately addressed within 30 days, FDA may terminate the IND.''

Annual reports (A) are required but noncompliance usually results in clinical hold, not immediate termination. IRB approval delays (B) do not trigger termination; the site simply cannot begin. Investigators report safety data to sponsors, not directly to FDA (C).

Thus, the correct answer is D (The FDA issued a clinical hold, and 30 days have elapsed).

21 CFR 312.44(b)(1) (Termination of an IND).

21 CFR 312.42(e) (Clinical hold procedures).

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17 comments · newest first

Jettie 23 days ago

I think B) is critical. Without IRB, you can't proceed.

Glory 28 days ago

All options have merit, but A) stands out for me.

Alpha 1 month ago

I’m leaning towards A). Accurate reporting is essential.

Leila 1 month ago

I feel like D) is less likely. 30 days is a long wait.

Vivan 1 month ago

C) is definitely a reason too. Safety is crucial.

Catalina 2 months ago

But B) could also be valid. No IRB approval means no study.

Velda 2 months ago

I agree. A) seems like a strong choice.

Teddy 2 months ago

This question is tricky. I think it's about compliance.

Cecilia 2 months ago

D) makes sense, 30 days is a long time to wait!

Jolanda 2 months ago

B) seems important too, can't enroll without approval.

Alysa 2 months ago

Wait, can they really terminate just for that?

Glory 3 months ago

Totally agree, safety reports are crucial!

Beata 3 months ago

A) is correct, they need accurate reports.

Danilo 3 months ago

I thought a clinical hold could lead to termination if 30 days pass, but I’m not clear on the specifics of that situation.

Gerald 3 months ago

I feel like the safety reports are really important, so if an investigator doesn't submit those, it could definitely be a reason for termination.

Margarett 3 months ago

I remember something about IRB approvals being crucial, but I can't recall if that alone would lead to termination during Phase I.

Rima 4 months ago

I think the FDA can terminate an IND if the sponsor fails to submit an accurate annual report, but I'm not entirely sure if that's the only reason.

SOCRA CCRP Exam - Topic 1 Question 16 Discussion