CCRP Exam Preparation Material | Certified Clinical Research Professional

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Prepare for the CCRP Certified Clinical Research Professional exam with CertQueen's independently developed study resources. Review important concepts, practice scenario-based questions, and use clear explanations to identify areas that require further study.

Question#1

Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

A. China
B. Switzerland
C. Brazil
D. India

Explanation:
India has aligned national regulations with ICH-GCP.
DCGI/ICMR Guidelines (India): Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.
China and Brazil are harmonizing, but full official adoption is noted in India.
Reference: Indian GCP Guidelines (2017 revision).

Question#2

An investigator discovered a new serious unanticipated adverse device effect.
Who must they notify?

A. FDA
B. Sponsor
C. Research pharmacist
D. OHRP

Explanation:
21 CFR 812.150(a)(1): Investigators must report unanticipated adverse device effects to the sponsor within 10 working days.
Sponsor is then responsible for notifying FDA and all investigators.
Reference: 21 CFR 812.150(a)(1).

Question#3

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

A. Execute material transfer agreement
B. Ship under dangerous goods requirements
C. Obtain IRB/IEC approval for revised protocol and ICF
D. Notify enrolled subjects

Explanation:
21 CFR 56.109(a): IRB must review and approve any protocol amendments before implementation.
ICH E6(R2) 4.5.2: Changes affecting subjects (e.g., genomic testing) require IRB/IEC approval and updated consent.
Thus, site must first obtain IRB approval for revised protocol and ICF.
Reference: 21 CFR 56.109(a); ICH E6(R2) §4.5.2.

Question#4

In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study.
Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?

A. The site’s SOPs
B. The delegation of duties log
C. The site’s accreditation certificate
D. The IRB/IEC trial approval documentation

Explanation:
ICH E6(R2) 4.4.1: “Before initiating a trial, the investigator/institution should have written and dated approval/favorable opinion from the IRB/IEC.”
Sponsors must confirm IRB approval before authorizing initiation.
Reference: ICH E6(R2), §4.4.1.

Question#5

According to the CFR, which of the following is a complete and accurate list of the signatures required on the short form consent document?

A. The subject or else the subject's legally authorized representative; the witness
B. The subject or else the subject's legally authorized representative
C. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee
D. The subject or else the subject's legally authorized representative; the investigator or else the investigator's designee; the witness

Explanation:
The short form consent process is permitted when the subject is presented with a brief written statement that they were informed of the study, supplemented by an oral presentation.
21 CFR 50.27(b)(2): Requires the short form to be signed by the subject (or legally authorized representative) and a witness.
The witness ensures that oral consent was properly conveyed and understood.
The person obtaining consent must sign a separate written summary, but not the short form itself.
Thus, the accurate answer is A: subject (or LAR) + witness.
Reference: 21 CFR 50.27(b)(2).

Exam Code: CCRP
Q & A: 130 Q&As         Updated:  Nov 03,2026

 

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What This CCRP Study Resource Helps You Do

Review Key Concepts

Review the technologies, products, processes, and practical skills covered by the current CCRP exam objectives.

Practice Scenario-Based Questions

Work through independently developed questions designed to strengthen your understanding of technical scenarios and decision-making.

Identify Knowledge Gaps

Use your results and the provided explanations to find weaker areas and focus your study more effectively.

How to Use This CCRP Preparation Material

Review the Exam Scope

Start by reviewing the topics covered by the CCRP exam. Compare them with the official exam objectives to understand the required technologies, operational tasks, and practical skills, then identify the areas that deserve the most attention.

Practice Independently

Complete a focused set of practice questions for each topic. On your first attempt, avoid referring to notes, answers, or other study resources so that you can evaluate your current understanding more accurately.

Study the Explanations

Review the answers and explanations after completing each practice session. Understand why the correct option is appropriate for the given scenario and why the other options may be incorrect or less suitable.

Close Knowledge Gaps

Keep track of incorrect answers, unfamiliar concepts, and weaker knowledge areas. Review these topics using official documentation and practical experience, then answer the related questions again to reinforce your understanding and monitor your progress.

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Exam Code: CCRP
Q & A: 130 Q&As
Updated:  Nov 03,2026

 

 Access Complete CCRP Preparation Material