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Exam Review

Key Facts: CCRC Exam

125

Total Questions

ACRP Certification Handbook

100

Scored Questions

ACRP Certification Handbook

3 hours

Time Limit

ACRP CCRC exam page

$435-$600

Application + Exam Fee

ACRP 2026 registration fees

3,000 hrs

Required Experience

ACRP CCRC eligibility

2 years

Renewal Cycle

ACRP certification maintenance

The CCRC exam covers six content domains referenced exclusively to ICH Guidelines, with Clinical Trial Operations (23%), Study/Site Management (22%), and Ethical/Participant Safety (19%) comprising 64% of the examination outline. ACRP offers testing twice per year through PSI with remote and in-person options, and ICH E6(R3) has controlled ACRP exams since July 15, 2026.

Sample CCRC Practice Questions

Try these sample questions to review concepts for the CCRC exam. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1What is the primary purpose of a clinical trial protocol?

A.To provide financial projections for the sponsor organization

B.To outline the marketing strategy for the investigational product

C.To document patient medical histories prior to enrollment

D.To describe the trial's objectives, design, methodology and organization

Explanation: A clinical trial protocol is the essential document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. It serves as the blueprint for how the study will be conducted and ensures consistency across all study sites. ICH E6 GCP defines the protocol as the foundation of trial conduct.

2Which of the following is an example of a primary endpoint in a clinical trial?

A.The number of sites participating in the trial

B.The total cost of conducting the clinical trial

C.The number of screen failures recorded during enrollment, used to judge how well the site recruits

D.The pre-specified main outcome used to judge whether the intervention works

Explanation: A primary endpoint is the pre-specified main result that a clinical trial is designed to evaluate. It is the most important outcome measure and is directly related to the trial's primary objective. The primary endpoint drives the statistical powering and sample size calculations for the study.

3In a double-blind clinical trial, who is unaware of the treatment assignment?

A.Only the study participants

B.Only the investigators and study staff

C.Only the sponsor's medical monitor, while participants and site staff know the assignment

D.Both the study participants and the investigators/study staff

Explanation: In a double-blind (double-masked) clinical trial, neither the study participants nor the investigators and study staff know which treatment each participant is receiving. This design minimizes bias in treatment administration, data collection, and outcome assessment. Blinding is a fundamental concept in research design to maintain study integrity.

4What is the purpose of the Investigator's Brochure (IB)?

A.To document every adverse event that occurs during the trial so that sites can compare their safety findings

B.To serve as the informed consent form for study participants

C.To summarize the clinical and nonclinical data on the investigational product for investigators

D.To outline the site's standard operating procedures

Explanation: According to ICH E6 GCP, the Investigator's Brochure (IB) is a compilation of clinical and nonclinical data on the investigational product that are relevant to the study of the product in human subjects. It provides investigators with information to help them understand the rationale for and comply with key features of the protocol, including dosing, dose frequency, methods of administration, and safety monitoring procedures.

5A phase III clinical trial typically has which of the following characteristics?

A.First-in-human dose escalation study with a small number of healthy volunteers

B.Post-marketing surveillance study to detect rare adverse effects

C.Small exploratory study to determine optimal dosing and pharmacokinetics

D.Large confirmatory study of efficacy and safety to support regulatory approval

Explanation: Phase III clinical trials are large-scale, confirmatory studies that compare the investigational product against the standard of care or placebo to demonstrate sufficient evidence of efficacy and safety for regulatory submission. These trials typically involve hundreds to thousands of participants and provide the pivotal data needed for marketing authorization.

6What is the difference between randomization and stratification in clinical trial design?

A.Randomization is used only in Phase I trials, while stratification is used only in Phase III trials

B.Randomization assigns groups by chance; stratification balances key characteristics across the groups

C.Randomization is performed by the investigator, while stratification is performed by the participant

D.There is no difference; both terms describe the same process

Explanation: Randomization is the process of assigning participants to treatment groups using a chance mechanism, which helps eliminate selection bias. Stratification is a technique used in conjunction with randomization to ensure that important prognostic factors (such as age, disease severity, or sex) are evenly distributed across treatment groups. Together, they strengthen the validity of study results.

7A researcher plans to evaluate a new antibiotic using a study design where neither the participant, investigator, nor the outcome assessor knows the treatment assignment. This is best described as:

A.Open-label study

B.Single-blind study

C.Triple-blind study

D.Double-blind study

Explanation: A triple-blind study extends the double-blind design by also blinding the outcome assessors (or data analysts) in addition to the participants and investigators. This provides the highest level of bias reduction by ensuring that treatment knowledge cannot influence outcome evaluation at any level. While the term is less commonly used in ICH guidelines, it describes this three-level blinding approach.

8Which statistical concept describes the probability of a clinical trial correctly detecting a true treatment effect when one exists?

A.P-value

B.Statistical power

C.Confidence interval

D.Standard deviation

Explanation: Statistical power is the probability that a study will detect a statistically significant difference when a true difference exists between treatment groups. It is typically set at 80% or higher and is a critical factor in sample size calculations. Inadequate power increases the risk of a Type II error (failing to detect a real effect).

9What is the primary purpose of informed consent in clinical research?

A.To protect the sponsor from legal liability

B.To ensure the participant understands the study and voluntarily agrees to participate

C.To fulfill a regulatory requirement without regard to participant comprehension

D.To document the participant's medical history

Explanation: The primary purpose of informed consent is to ensure that potential participants understand the nature, purpose, risks, benefits, and alternatives of the clinical trial and voluntarily agree to participate. ICH E6 GCP and the Declaration of Helsinki emphasize that informed consent is an ongoing process that protects the participant's autonomy and right to make an informed decision.

10According to ICH GCP, when must informed consent be obtained from a study participant?

A.Before the participant is involved in any study-related procedures

B.After the participant has completed the first study visit

C.At the time of the final study visit only

D.Only when the participant asks for information about the study

Explanation: ICH E6 GCP requires that informed consent be obtained before the subject is submitted to any clinical trial procedures. This includes screening assessments, collection of biological samples, or any protocol-specific interventions. The consent process must be documented before any study-related activities begin.

About the CCRC Exam

The CCRC (Certified Clinical Research Coordinator) credential from ACRP formally recognizes clinical research professionals with experience coordinating and facilitating clinical trial activities in adherence to ICH GCP guidelines, under the direction of a principal investigator. The exam consists of 125 multiple-choice questions (100 scored, 25 pretest) and must be completed within 180 minutes.

Exam sponsor: ACRP / PSI. The requirements and fees below concern the certification or admission exam, separate from our free practice resources.

Questions

125 questions

Time Limit

3 hours (180 minutes)

Passing Score

Scaled score 600 (raw percentage equivalent not published)

Exam / Certification Fees

$435-$600 total for application and exam (varies by ACRP membership status and registration timing)

Exam sponsor website

Fees, eligibility, and exam policies can change. Confirm them with the exam sponsor before applying or paying.

Official sources

Our practice resources: topics covered

We aim to reflect publicly available exam outlines and topic information in our study resources. Coverage, format, and difficulty may differ from the actual exam, and we cannot guarantee that every detail is accurate or current. Confirm exam requirements, fees, and policies with the official exam sponsor.

Scientific Concepts and Research Design

Protocol elements, study design, investigational brochures, research methodology, biostatistics fundamentals, and clinical endpoints

19%

Ethical and Participant Safety Considerations

Informed consent processes, IRB/IEC oversight, Declaration of Helsinki, adverse event reporting, vulnerable populations, and conflicts of interest

13%

Product Development and Regulation

Drug and device development phases, regulatory submissions, investigational product accountability, labeling, and post-market requirements

23%

Clinical Trial Operations (GCPs)

ICH E6 GCP principles, protocol adherence, monitoring visits, essential documents, deviations, amendments, and quality management

22%

Study and Site Management

Site startup and closeout, investigational product storage, budgets, contracts, equipment, staffing, enrollment management, and compliance

15%

Data Management and Informatics

Source documentation, CRF/eCRF completion, data queries, electronic data capture, data privacy, and records retention

Preparing for the CCRC Exam

What You Need to Know

Passing score: Scaled score 600 (raw percentage equivalent not published)
Exam length: 125 questions
Time limit: 3 hours (180 minutes)
Exam / certification fees: $435-$600 total for application and exam (varies by ACRP membership status and registration timing) Official sources

Using Our Practice Resources

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CCRC: Suggested Study Strategy

1Focus on the three highest-weighted domains first: Clinical Trial Operations (23%), Study/Site Management (22%), and Ethical/Participant Safety (19%) — together they comprise 64% of the outline

2Read ICH E6(R3) GCP thoroughly because it has controlled ACRP examinations since July 15, 2026

3Practice applying informed consent principles to scenario-based questions involving vulnerable populations including pediatric subjects

4Master adverse event classification and reporting timelines including the difference between AEs, SAEs, SUSARs, and expedited safety reports per ICH E2A

5Study investigational product accountability procedures including receipt, storage, dispensing, and return/destruction documentation

Frequently Asked Questions

How many questions are on the CCRC exam?

The CCRC exam has 125 multiple-choice questions total: 100 scored items and 25 unidentified pretest items that do not affect your score. You have 180 minutes to complete all 125 questions.

What is the passing score for the CCRC exam?

ACRP requires a scaled score of 600 and does not publish a raw percentage equivalent. Results include pass/fail and domain-level performance feedback.

How much does the CCRC exam cost?

Fees range from $435 to $600 depending on ACRP membership status and registration timing. Early bird registration for ACRP members is $435, while regular registration for non-members is $600.

What are the eligibility requirements for the CCRC?

Candidates must document 3,000 verified hours of clinical research coordinator experience. ACRP may grant one 1,500-hour waiver to candidates who hold an active CCRA, ACRP-CP or CPI certification or who have completed an accredited clinical research education program; the waiver reduces the experience requirement to 1,500 hours but does not replace it.

When can I take the CCRC exam?

ACRP offers the CCRC exam twice per year in fixed testing windows: Spring (February 15 - May 15) and Fall (July 15 - October 15). Testing is available remotely or at PSI test centers.

What references should I study for the CCRC exam?

The exam is referenced to ICH Guidelines and the Declaration of Helsinki. ICH E6(R3) replaced E6(R2) across ACRP examinations on July 15, 2026.

How often do I need to renew my CCRC certification?

Renew every two years with 24 activity points, including at least 12 research-specific continuing-education points, plus the applicable maintenance fee.

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