SOCRA CCRP Exam - Topic 2 Question 10 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 10
Topic #: 2

[All CCRP Questions]

After the sponsor's auditor completes the final audit report for a Phase II trial with an investigational new drug, Which option best is responsible for providing the audit certificate to the clinical site?

AThe IRB/IEC

BThe regulatory authority

CThe Data Safety Monitoring Board

DThe sponsor

Show Suggested Answer

Suggested Answer: D

Audits are part of sponsor quality assurance to ensure trial compliance.

ICH E6(R2) 5.19.3: ''The sponsor's auditing procedures should include the provision of an audit certificate where required.''

ICH E6(R2) 8.2.20: Audit certificates are essential documents generated and retained by the sponsor.

IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only the sponsor issues and maintains audit certificates, providing them to sites when appropriate.

Correct answer: D.

ICH E6(R2), 5.19.3.

ICH E6(R2), 8.2.20.

by Rikki at Jan 28, 2026, 05:13 AM

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Zana

5 days ago

I remember a practice question where the site was involved in the audit process, but I can't recall if they provide the certificate.

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Doug

10 days ago

I think the sponsor is responsible for providing the audit certificate, but I'm not entirely sure.

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Weldon

15 days ago

Yeah, I agree. This is about understanding the typical flow of information and documentation in a clinical trial. The sponsor should be the one to provide the audit certificate to the site.

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Corrie

20 days ago

I think the key here is understanding the relationship between the sponsor, auditor, and clinical site. The sponsor is likely the one who needs to officially share the audit results with the site.

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Lorrie

25 days ago

I'm a bit confused on this one. Is the sponsor always responsible for providing the audit certificate, or does it depend on the specific trial details?

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Nakita

1 month ago

Okay, let's see. The auditor completed the final report, so I'm guessing the sponsor is responsible for providing the audit certificate to the site.

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Ashleigh

1 month ago

Hmm, this seems like a tricky one. I'll need to think through the different roles and responsibilities carefully.

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