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Latest CCRP Exam Practice Questions

The practice questions for CCRP exam was last updated on 2025-10-13 .

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Question#1

An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety.
Which of the following parties, if any, is the investigator required to notify?

A. The IRB/IEC

B. The Data Safety Monitoring Board (DSMB)

C. The regulatory authority

D. No notification is required

Explanation:
The Investigator’s Brochure (IB) is updated by the sponsor to reflect new scientific or clinical information.
ICH E6(R2) 7.3: “The sponsor should revise the IB as soon as new, significant information becomes available.”
ICH E6(R2) 4.1.5: Requires the investigator to ensure staff are informed, but there is no requirement to notify IRB/IEC unless subject safety, rights, or risk profile is affected.
Since this update contained no changes related to subject safety, the investigator is not obligated to notify IRB/IEC, DSMB, or regulators. The updated IB must simply be filed in the regulatory binder and implemented at the site.
Thus, the correct answer is D (No notification is required).
Reference: ICH E6(R2), §7.3 (Updating the Investigator’s Brochure).
ICH E6(R2), §4.1.5 (Investigator responsibilities for informing staff).

Question#2

After completion of a Phase III trial, which document should IRB/IEC retain?

A. Occupations and affiliations of IRB members

B. Sponsor/investigator contracts

C. Subject enrollment logs

D. Investigational product labels

Explanation:
21 CFR 56.115(a)(5): IRBs must retain records of IRB membership (names, qualifications, affiliations, occupations).
Other documents (contracts, enrollment logs, product labels) are site or sponsor responsibilities, not IRB’s.
Reference: 21 CFR 56.115(a)(5).

Question#3

Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

A. 400 mg/m²

B. 420 mg/m²

C. 444 mg/m²

D. 492 mg/m²

Explanation:
370 × 1.20 = 444 mg/m².
Accurate dosing calculations are critical for protocol adherence and patient safety.
Reference: Standard pharmacology dose adjustment principles; ICH E6(R2) §4.5.1.

Question#4

A clinical investigator wants to publish a subject’s unique results. The consent form did not mention publication.
What is required?

A. Approval from monitor

B. Consent from subject

C. IRB chair approval

D. Nothing further

Explanation:
ICH E6(R2) 4.8.10(n): Consent must include explanation about confidentiality and possible publication.
If not included, specific subject consent must be obtained before publishing identifiable results.
Thus, subject’s explicit permission is required.
Reference: ICH E6(R2) §4.8.10(n).

Question#5

In accordance with ICH, which of the following is an acceptable protocol review frequency for an IRB?

A. 6 months

B. 12 months

C. 24 months

D. 36 months

Explanation:
IRBs must review protocols at least annually to ensure ongoing subject protection.
21 CFR 56.109(f): “An IRB shall conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year.”
ICH E6(R2) 3.1.4: “The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk, but at least once per year.”
This establishes 12 months as the minimum required interval. More frequent reviews (e.g., 6 months) may occur for higher-risk studies, but longer intervals (24C36 months) are not permitted.
Correct answer: B (12 months).
Reference: 21 CFR 56.109(f). ICH E6(R2), §3.1.4.

Exam Code: CCRPQ & A: 130 Q&AsUpdated: 2025-10-13

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