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100% Pass 2026 Realistic Reliable CCRP Braindumps Sheet - Certified Clinical Research Professional (CCRP) Latest Exam Preparation

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SOCRA Certified Clinical Research Professional (CCRP) Sample Questions (Q52-Q57):

NEW QUESTION # 52
In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

A. Sponsor
B. Regulatory authority
C. Investigator
D. Institution

Answer: A

Explanation:
* ICH E6(R2) 5.5.3:Sponsors are responsible for validating computerized systems used in trials.
Investigators ensure proper data entry, but system compliance lies with sponsor.
References:ICH E6(R2), §5.5.3.

NEW QUESTION # 53
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 regulatory authority
C. No notification is required
D. The Data Safety Monitoring Board (DSMB)

Answer: C

Explanation:
TheInvestigator'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 isno requirementto notify IRB/IEC unless subject safety, rights, or risk profile is affected.
Since this update containedno 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 theregulatory binderand implemented at the site.
Thus, the correct answer isD (No notification is required).
References:
ICH E6(R2), §7.3 (Updating the Investigator's Brochure).
ICH E6(R2), §4.1.5 (Investigator responsibilities for informing staff).

NEW QUESTION # 54
In accordance with the CFR, which of the following statements regarding the informed consent document is correct?

A. It identifies all of the applicable mandated basic elements
B. It is signed and dated by the IRB/IEC chair
C. It does not identify some of the applicable mandated basic elements
D. It is signed and dated by the subject's legally authorized representative

Answer: A

Explanation:
The informed consent document (ICD) is a cornerstone of ethical clinical research, ensuring voluntary participation and protection of subject rights.
* 21 CFR 50.25(a):Requires the consent form to containall basic elements, including study purpose, risks, benefits, alternatives, confidentiality, compensation, and voluntariness.
* ICH E6(R2) 4.8.10:Expands on these requirements, ensuring the ICD contains every mandated element without omission.
Thus, the correct statement is that the ICDmust include all applicable mandated basic elements(D).
Options A and B confuse who signs-subjects or legally authorized representatives sign when applicable, not the IRB chair. Option C is incorrect because leaving out elements would violate compliance.
Correct answer:D.
References:
21 CFR 50.25(a).
ICH E6(R2), §4.8.10.

NEW QUESTION # 55
Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?

A. The selection of subjects is equitable
B. The sponsor is qualified to provide oversight of the trial
C. A plan for the publication of study results is in place
D. The investigator has adequate access to patients eligible for the trial

Answer: A

Explanation:
IRB/IEC review focuses onethical protection of human subjects. Equitable subject selection is a cornerstone principle.
* 45 CFR 46.111(a)(3):"In order to approve research... the IRB shall determine that:Selection of subjects is equitable."
* ICH E6(R2) 3.1.2:"The IRB/IEC should safeguard the rights, safety, and well-being of all trial subjects... with particular attention to trials that may include vulnerable subjects." Publication plans (A) are not required by IRBs. Access to patients (C) and sponsor qualifications (D) are evaluated by sponsors, not IRBs. The IRB's role is ensuring fairness, minimizing coercion, and protecting vulnerable populations.
Thus, the correct answer isB (The selection of subjects is equitable).
References:
45 CFR 46.111(a)(3) (Equitable subject selection).
ICH E6(R2), §3.1.2 (IRB/IEC role).

NEW QUESTION # 56
According to ICH GCP, sponsor-specific essential documents must be retained until:

A. 3 years after last approval
B. 5 years after last approval
C. 25 years after last approval
D. 2 years after last approval and no pending applications

Answer: D

Explanation:
* ICH E6(R2) 5.5.12 & 8.1:Essential documents must be retained2 years after the last approval of a marketing application in an ICH region and until no applications are pending, or2 years after discontinuation of development.
This ensures availability for inspection.
References:ICH E6(R2) §§5.5.12, 8.1.

NEW QUESTION # 57
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