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SOCRA CCRP Exam - Topic 1 Question 2 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 2
Topic #: 1

[All CCRP Questions]

During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?

AThe investigator

BThe IRB/IEC chair

CThe sponsor

DThe CRO

Show Suggested Answer

Suggested Answer: C

The sponsor holds ultimate responsibility for trial oversight and compliance.

ICH E6(R2) 5.20.1: If noncompliance is discovered, the sponsor must ''take prompt action to secure compliance'' and, if necessary, terminate participation of the investigator/institution.

21 CFR 312.56(b): Sponsors must ensure proper conduct and report investigators who fail to comply to the FDA and IRB.

While investigators commit to protocol adherence, once deviations are identified, the sponsor must act to safeguard subjects and trial validity.

by Aileen at Oct 03, 2025, 03:53 AM

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Keneth

2 months ago

Definitely the sponsor, they hold the ultimate accountability.

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Lashawnda

2 months ago

Wait, I thought the investigator had more responsibility in these cases?

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Delmy

2 months ago

Totally agree, the sponsor has to step up!

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Yolando

3 months ago

Really? I’m surprised it’s not the investigator’s job to report those deviations!

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Tanesha

3 months ago

It's the sponsor's responsibility to ensure compliance.

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Tammi

3 months ago

This is tricky! I want to say the sponsor, but I also remember discussions about the IRB's role in oversight.

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Jackie

3 months ago

I feel like the CRO might have some role in this, but I can't recall if they have the final say on compliance issues.

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Thea

4 months ago

I remember a similar question where the investigator was held accountable for protocol deviations. Could it be A?

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Marci

4 months ago

I think the sponsor is usually responsible for ensuring compliance, but I'm not entirely sure if the investigator has some obligations too.

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Ronny

4 months ago

This is a good test of my understanding of clinical trial oversight. I'll make sure to consider each party's obligations under the regulations.

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Lucina

4 months ago

I'm a bit confused by the wording of the question. Let me re-read it carefully and think through the different options.

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Raina

4 months ago

Okay, I think I know the answer here. The sponsor has the ultimate responsibility to ensure compliance, so I'd go with C.

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Kate

4 months ago

Hmm, not sure about this one. I'll need to review the roles and responsibilities of the different parties in a clinical trial.

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Olen

5 months ago

This seems like a straightforward compliance question. I'd focus on the key parties involved and their responsibilities.

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