100+ Free ACRP-CP Practice Questions

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Question 1

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According to ICH E6(R2), what is the primary purpose of Good Clinical Practice (GCP) guidelines?

To provide a unified standard that facilitates mutual acceptance of clinical data by regulatory authorities

To establish financial guidelines for clinical trial funding

To define the organizational structure of pharmaceutical companies

To regulate the pricing of investigational products

to track

2026 Statistics

Key Facts: ACRP-CP Exam

125

Exam Questions (100 scored)

ACRP Certification Handbook

180 min

Exam Time

ACRP Certification Handbook

600

Passing Scaled Score

ACRP Certification Handbook

$435-$600

Exam Fee Range

ACRP 2026 registration

3,000 hrs

Work Experience Required

ACRP-CP eligibility

2 years

Certification Renewal Cycle

ACRP maintenance policy

The ACRP-CP exam consists of 125 multiple-choice questions (100 scored, 25 unscored pre-test items) to be completed in 180 minutes. The passing scaled score is 600. Registration fees range from $435 (ACRP member early bird) to $600 (nonmember regular). Candidates must have 3,000 hours of verifiable clinical research work experience. Beginning July 15, 2026, the ICH E6(R3) Guideline for Good Clinical Practice will replace E6(R2) across all ACRP examinations.

Sample ACRP-CP Practice Questions

Try these sample questions to test your ACRP-CP exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1According to ICH E6(R2), what is the primary purpose of Good Clinical Practice (GCP) guidelines?

A.To provide a unified standard that facilitates mutual acceptance of clinical data by regulatory authorities

B.To establish financial guidelines for clinical trial funding

C.To define the organizational structure of pharmaceutical companies

D.To regulate the pricing of investigational products

Explanation: ICH E6(R2) GCP provides an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Its primary purpose is to ensure mutual acceptance of clinical data by regulatory authorities across different countries, thereby reducing redundant trials and facilitating global drug development.

2Which of the following is a fundamental principle of ICH GCP regarding the rights of trial subjects?

A.Trial subjects may be compensated only after completing the full study

B.The rights, safety, and well-being of trial subjects are the most important considerations and should prevail over interests of science and society

C.Subject rights are secondary to scientific advancement in Phase I trials

D.Trial subjects have no right to withdraw once they have signed the informed consent form

Explanation: ICH E6(R2) Section 2.3 states that the rights, safety, and well-being of trial subjects are the most important considerations and should prevail over interests of science and society. This fundamental principle applies to all phases of clinical trials and is central to GCP compliance.

3According to ICH GCP, which document should be reviewed by the investigator before initiating a clinical trial?

A.The marketing authorization application

B.The Investigator's Brochure (IB)

C.The annual financial report of the sponsor

D.The manufacturing license for the investigational product

Explanation: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product relevant to the study. Per ICH GCP, the investigator should be familiar with the IB content before initiating the trial, as it provides essential safety, pharmacology, and dosing information needed for proper trial conduct.

4A clinical research coordinator discovers that a study subject received a dose of the investigational product that was 50% higher than specified in the protocol. What is the FIRST action the coordinator should take?

A.Discontinue the subject from the study immediately

B.Wait for the next scheduled visit to address the issue

C.Ensure the subject's immediate safety and document the event as a protocol deviation

D.Contact the sponsor to request additional investigational product

Explanation: When a protocol deviation occurs, particularly one involving an incorrect dose, the first priority is always subject safety. The coordinator should ensure the subject's immediate safety by assessing for any adverse effects, then properly document the event as a protocol deviation. Further actions such as reporting to the IRB/IEC and sponsor follow after the subject's safety is secured.

5Which of the following is considered an essential document that should be maintained in the trial master file according to ICH GCP?

A.Investigator's personal financial portfolio

B.Signed informed consent forms for each subject

C.The sponsor's corporate organizational chart

D.Marketing materials for the investigational product

Explanation: Signed informed consent forms are essential documents that must be maintained in the trial master file per ICH E6(R2) Section 8. These documents verify that proper informed consent was obtained before any trial-related procedures. Essential documents enable the conduct, oversight, and evaluation of the quality of the trial.

6During a monitoring visit, a CRA discovers that the investigator has not been reporting adverse events within the timeframes specified in the protocol. What should the CRA do?

A.Ignore the issue since the events were eventually reported

B.Document the finding, ensure corrective actions are implemented, and report to the sponsor

C.Immediately close the site without further discussion

D.Instruct the site staff to backdate the adverse event reports

Explanation: Per ICH GCP, the monitor should verify that adverse events are reported within the timeframes required by the protocol and applicable regulations. When non-compliance is found, the CRA should document the finding, work with the site to implement corrective actions, and report the issue to the sponsor. This ensures data integrity and subject safety while maintaining proper oversight.

7According to ICH GCP, what is the primary purpose of source document verification (SDV) during monitoring?

A.To verify that the data reported in the CRFs are accurate and consistent with the source documents

B.To ensure the site has enough office supplies

C.To assess the investigator's financial status

D.To evaluate the aesthetic quality of the facility

Explanation: Source document verification (SDV) is a key monitoring activity where the CRA compares data entered in case report forms (CRFs) against the original source documents (medical records, lab reports, etc.) to ensure accuracy, completeness, and consistency. This process is fundamental to ensuring data integrity in clinical trials.

8Which of the following best describes the role of a quality management system (QMS) in clinical trials as outlined in ICH E6(R2)?

A.A system focused solely on reducing trial costs

B.A systematic approach to ensure trial quality, including risk identification, assessment, control, and review

C.A database for storing subject demographic information

D.A training program exclusively for new clinical research staff

Explanation: ICH E6(R2) Section 5.0 introduces quality management as a systematic approach that incorporates risk-based thinking. A QMS includes risk identification, assessment, control, communication, and review processes designed to ensure the protection of subject rights and safety and the reliability of trial results. It goes beyond cost reduction to encompass all aspects of trial quality.

9A sponsor implements risk-based monitoring (RBM) for a multi-site clinical trial. Which of the following activities is MOST consistent with an RBM approach?

A.Performing 100% SDV at every site regardless of risk assessment

B.Eliminating all on-site monitoring visits

C.Using centralized data analytics to identify sites with data anomalies and prioritizing on-site visits for higher-risk sites

D.Delegating all monitoring responsibilities to the investigator

Explanation: Risk-based monitoring, as described in ICH E6(R2), uses centralized data review and analytics to identify quality and safety issues, then directs monitoring resources to areas of greatest risk. This approach uses data-driven decision making to focus on-site activities where they are most needed rather than applying a one-size-fits-all monitoring strategy.

10According to ICH GCP, which of the following must be included in the trial protocol?

A.The investigator's vacation schedule

B.A description of the statistical methods to be employed, including the planned number of subjects

C.The sponsor's marketing strategy for the product

D.The salary structure for site staff

Explanation: ICH E6(R2) Section 6 specifies that the protocol should include a description of the statistical methods to be employed, including timing of planned interim analyses, the number of subjects planned, and the level of significance to be used. Statistical methodology is essential for ensuring the trial can adequately address its objectives.

About the ACRP-CP Exam

The ACRP-CP (ACRP Certified Professional) is a role-agnostic clinical research credential from the Association of Clinical Research Professionals. Unlike the role-specific CCRC (coordinators) or CCRA (monitors), the ACRP-CP is designed for any clinical research professional involved in planning, conducting, or overseeing clinical trials. The exam tests proficiency across six core knowledge areas referenced exclusively to ICH Guidelines.

Questions

125 scored questions

Time Limit

3 hours (180 minutes)

Passing Score

Scaled score of 600

Exam Fee

$435-$600 (ACRP / PSI)

ACRP-CP Exam Content Outline

25%

Clinical Trial Operations (GCPs)

GCP principles, protocol compliance, monitoring activities, essential documents, and quality management systems

23%

Study and Site Management

Site selection, feasibility assessment, subject recruitment/retention, visit activities, vendor management, and study close-out

19%

Ethical and Participant Safety Considerations

Informed consent, IRB/IEC requirements, adverse event reporting, vulnerable populations, Declaration of Helsinki, and participant rights

16%

Investigational Product/Device Regulation

IP accountability, storage/handling, blinding procedures, regulatory submissions, and IND/IDE requirements

Data Management and Informatics

Data collection methods, EDC systems, query resolution, data validation, coding dictionaries, and database lock procedures

Scientific Concepts and Research Design

Study phases, randomization, blinding, endpoints, biostatistics fundamentals, and protocol design elements

How to Pass the ACRP-CP Exam

What You Need to Know

Passing score: Scaled score of 600
Exam length: 125 questions
Time limit: 3 hours (180 minutes)
Exam fee: $435-$600

Keys to Passing

Complete 500+ practice questions
Score 80%+ consistently before scheduling
Focus on highest-weighted sections
Use our AI tutor for tough concepts

ACRP-CP Study Tips from Top Performers

1Prioritize Clinical Trial Operations (25%) and Study/Site Management (23%) — together they account for nearly half of scored questions

2Read ICH E6(R2) GCP guideline cover to cover and create summary notes for each section; starting July 2026 the exam transitions to E6(R3)

3Study ICH E2A for adverse event classification and expedited reporting timelines — safety reporting is tested across multiple domains

4Practice scenario-based questions that require applying GCP principles to real-world situations rather than simple recall

5Review the Declaration of Helsinki and understand how it differs from ICH GCP in protecting research participants

Frequently Asked Questions

How many questions are on the ACRP-CP exam?

The ACRP-CP exam consists of 125 multiple-choice questions. Of these, 100 are scored and 25 are unscored pre-test items used for future exam development. Pre-test items are not identified to candidates.

What is the passing score for the ACRP-CP exam?

The passing scaled score is 600. Raw scores are converted to a scaled score by PSI. The exam is not scored on a curve and there is no predetermined number of candidates permitted to pass.

How much does the ACRP-CP exam cost in 2026?

Registration fees for 2026 are: ACRP members early bird $435, ACRP members regular $460, nonmembers early bird $485, nonmembers regular $600. ACRP annual membership is $160.

What are the eligibility requirements for ACRP-CP?

Candidates must have 3,000 hours of verifiable work experience in clinical research related to human subject research through a paid employer/employee arrangement. Up to 1,500 hours may be waived for those holding an active ACRP certification or completing an accredited clinical research education program.

How does ACRP-CP differ from CCRC and CCRA?

The ACRP-CP is role-agnostic, designed for any clinical research professional regardless of specific function. The CCRC is specifically for coordinators and the CCRA is for clinical research associates/monitors. All three share the same exam format (125 questions, 180 minutes) and are referenced to ICH Guidelines.

What is changing with the ACRP-CP exam in 2026?

Beginning July 15, 2026, the ICH E6(R3) Guideline for Good Clinical Practice will replace E6(R2) across all ACRP examinations. Candidates testing during the Spring 2026 window (through May 15) will still be tested on E6(R2).

When can I take the ACRP-CP exam?

ACRP offers exams during two annual testing windows: Spring (February 15 through May 15) and Fall (July 15 through October 15). Exams are delivered at PSI testing centers.