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Question 1

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A clinical research project manager discovers that a study participant was enrolled without providing proper informed consent. What should be the project manager's FIRST action?

Continue the participant in the study while documenting the oversight

Immediately notify the IRB/Ethics Committee and the sponsor

Remove the participant from the study without notification

Wait until the next scheduled monitoring visit to address the issue

to track

2026 Statistics

Key Facts: ACRP-PM Exam

~80%

Pass Rate

ACRP 2022 Annual Report

433

Total Certified

ACRP 2022 Annual Report

60 Qs

Exam Questions

50 scored + 10 pretest

600/800

Passing Score

ACRP Certification Handbook

$250-300

Exam Fee

Member/non-member pricing

90 min

Time Limit

ACRP

The ACRP-PM exam consists of 60 multiple-choice questions (50 scored + 10 pretest) with a 90-minute time limit. The passing scaled score is 600 out of 800. The 2022 annual report showed an 80.5% pass rate with 433 total certified professionals. Candidates must hold an active ACRP-CP, CCRC, CCRA, or CPI certification and attest to 3,000 hours of clinical research project management experience. The exam covers six domains with Study Management (30%) and Clinical Trial Operations (25%) being the heaviest weighted areas.

Sample ACRP-PM Practice Questions

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

1A clinical research project manager discovers that a study participant was enrolled without providing proper informed consent. What should be the project manager's FIRST action?

A.Continue the participant in the study while documenting the oversight

B.Immediately notify the IRB/Ethics Committee and the sponsor

C.Remove the participant from the study without notification

D.Wait until the next scheduled monitoring visit to address the issue

Explanation: When a protocol deviation involving informed consent is discovered, the project manager must immediately notify the IRB/Ethics Committee and the sponsor. Informed consent is a fundamental ethical requirement under ICH E6(R2) and the Declaration of Helsinki. Delays in reporting can compromise participant safety and regulatory compliance.

2Which document outlines the ethical principles that form the foundation for ICH GCP guidelines regarding human subject protections?

A.The Nuremberg Code

B.The Declaration of Helsinki

C.The Belmont Report

D.21 CFR Part 50

Explanation: The Declaration of Helsinki, developed by the World Medical Association, establishes ethical principles for medical research involving human subjects and is specifically referenced as a foundational document for ICH GCP. While the Nuremberg Code and Belmont Report also address research ethics, the Declaration of Helsinki is the primary ethical framework cited by ICH guidelines.

3A project manager is developing a recruitment plan for a Phase III oncology trial. Which strategy BEST supports ethical participant recruitment?

A.Offering substantial financial incentives to maximize enrollment speed

B.Targeting vulnerable populations who may have limited treatment options

C.Ensuring recruitment materials are reviewed and approved by the IRB/Ethics Committee before use

D.Allowing individual sites to create their own recruitment advertisements without central review

Explanation: All recruitment materials must be reviewed and approved by the IRB/Ethics Committee before use to ensure they are not coercive, misleading, or inappropriately enticing. This protects potential participants' autonomy and ensures the informed consent process begins appropriately from the first point of contact.

4According to ICH GCP, what is the primary purpose of a Data Safety Monitoring Board (DSMB)?

A.To manage the trial budget and financial reporting

B.To periodically assess participant safety data and make recommendations about trial continuation

C.To ensure all sites are following the monitoring plan

D.To approve the statistical analysis plan before database lock

Explanation: A DSMB (also called a Data Monitoring Committee) is an independent group that periodically reviews unblinded safety data during a clinical trial and makes recommendations to the sponsor about whether the trial should continue, be modified, or be stopped. This function is critical for protecting participant safety throughout the study.

5A project manager identifies a potential conflict of interest at an investigative site where the principal investigator also holds equity in the sponsor company. What is the MOST appropriate action?

A.Disqualify the site immediately from participation

B.Ensure the conflict is disclosed and managed according to institutional and regulatory policies

C.Ignore the conflict since it does not affect data quality

D.Ask the investigator to divest their equity before the study begins

Explanation: Conflicts of interest must be identified, disclosed, and managed appropriately according to institutional policies and regulatory requirements. Complete disqualification is not always necessary if proper management and oversight measures are in place. The key is transparency and implementation of mitigation strategies to protect data integrity and participant welfare.

6What is the minimum information that must be included in the informed consent form according to ICH GCP E6(R2)?

A.Only the study procedures and potential risks

B.Study purpose, procedures, risks, benefits, alternatives, confidentiality provisions, and contact information

C.A brief summary of the protocol and the investigator's qualifications

D.The sponsor's name and the total number of participants expected to enroll

Explanation: ICH GCP E6(R2) Section 4.8 requires that informed consent include comprehensive information: the study's purpose, procedures, expected duration, risks, benefits, alternatives, confidentiality protections, compensation details, voluntary participation, right to withdraw, and contact information for questions. This ensures participants can make a truly informed decision.

7A participant in a clinical trial wants to withdraw from the study. According to ICH GCP, what is the project manager's responsibility?

A.Convince the participant to remain in the study to maintain enrollment targets

B.Ensure the participant's right to withdraw is respected without penalty or loss of benefits

C.Require the participant to complete all remaining assessments before withdrawal

D.Report the withdrawal as a protocol deviation to the IRB

Explanation: ICH GCP clearly states that participants have the right to withdraw from a trial at any time without penalty or loss of benefits to which they are otherwise entitled. The project manager must ensure this right is respected and that sites follow proper procedures for documenting withdrawals and collecting any safety follow-up data as permitted by the participant.

8A project manager is overseeing a multinational trial and must ensure participant privacy across multiple countries. Which ICH guideline principle should guide the project manager's approach?

A.Each country's privacy laws override all ICH requirements

B.The confidentiality of records that could identify subjects must be protected in accordance with applicable regulatory requirements

C.Privacy protections only apply to electronic health records, not paper documents

D.The sponsor may access all participant medical records without restriction for data verification

Explanation: ICH GCP requires that the confidentiality of records identifying subjects be protected, respecting privacy and confidentiality rules in accordance with applicable regulatory requirements. The project manager must ensure adequate confidentiality protections are maintained across all participating countries while complying with local regulations.

9What is the PRIMARY role of the IRB/Independent Ethics Committee (IEC) in the oversight of a clinical trial?

A.To manage the operational aspects of the trial at each site

B.To safeguard the rights, safety, and well-being of human subjects involved in a clinical trial

C.To negotiate the trial budget between the sponsor and investigative sites

D.To ensure enrollment targets are met within the planned timeline

Explanation: According to ICH GCP, the primary responsibility of the IRB/IEC is to safeguard the rights, safety, and well-being of all trial subjects. This includes reviewing and approving the protocol, informed consent documents, investigator qualifications, and ongoing safety data. The IRB/IEC operates independently from the sponsor and investigator.

10A project manager is developing a subject retention strategy for a 2-year long clinical trial. Which approach is MOST consistent with ethical principles?

A.Providing escalating financial incentives for each subsequent visit

B.Implementing patient-centric visit schedules and clear communication about study progress

C.Withholding final compensation until the participant completes the entire study

D.Limiting information about alternative treatments to discourage participant withdrawal

Explanation: Patient-centric approaches such as flexible scheduling, clear communication about study progress, and ongoing engagement promote retention while respecting participant autonomy. These strategies address practical barriers to participation without creating undue inducement or withholding information, maintaining ethical standards throughout the trial.

About the ACRP-PM Exam

The ACRP-PM certification from the Association of Clinical Research Professionals recognizes clinical research professionals with specialized knowledge in project management. This specialty credential validates proficiency in overseeing the planning, implementation, and execution of clinical trials within timelines, budgets, and regulatory requirements.

Questions

60 scored questions

Time Limit

90 minutes

Passing Score

Scaled score of 600 (out of 800)

Exam Fee

$250 (ACRP members) / $300 (non-members) (ACRP (PSI testing centers or online proctoring))

ACRP-PM Exam Content Outline

10%

Ethical and Participant Safety Considerations

Informed consent, human subject protections, safety monitoring, recruitment ethics, conflicts of interest, and participant privacy

10%

Regulatory Requirements

ICH guidelines compliance, essential documents, safety reporting timelines, protocol amendments, regulatory submissions, and document retention

25%

Clinical Trial Operations (GCPs)

Monitoring strategies, site initiation/close-out, investigational product management, quality management systems, CRO oversight, and data integrity

30%

Study Management

Project planning, budgeting, timeline management, vendor oversight, enrollment strategies, risk management, stakeholder communication, and resource allocation

10%

Scientific Concepts and Research Design

Clinical trial phases, study design types, statistical principles, endpoints, randomization, and clinical study reports

15%

Business Management, Leadership, and Professionalism

Team leadership, contract management, KPI development, SOP implementation, communication skills, and portfolio management

How to Pass the ACRP-PM Exam

What You Need to Know

Passing score: Scaled score of 600 (out of 800)
Exam length: 60 questions
Time limit: 90 minutes
Exam fee: $250 (ACRP members) / $300 (non-members)

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-PM Study Tips from Top Performers

1Focus on Study Management (30%) and Clinical Trial Operations (25%) — together they account for 55% of exam questions

2Master ICH GCP E6(R2) thoroughly, especially sections on monitoring (5.18), sponsor responsibilities (5.0), and quality management. Starting Fall 2026, study E6(R3) instead

3Know ICH E2A safety reporting timelines: 7 days for fatal/life-threatening SUSARs, 15 days for other SUSARs, and immediate investigator-to-sponsor SAE reporting

4Practice applying project management concepts (WBS, Gantt charts, critical path, EVM, RACI) specifically to clinical trial scenarios

5Review the ACRP-PM Detailed Content Outline (DCO) to identify knowledge gaps and structure your study plan around the six content domains

Frequently Asked Questions

What are the prerequisites for the ACRP-PM exam?

You must hold an active ACRP certification (ACRP-CP, CCRC, CCRA, or CPI) at the time of application. You must also attest to 3,000 hours of experience performing the tasks outlined in the ACRP-PM Detailed Content Outline. If your experience falls within 120 hours of the requirement by the first day of the exam window, full consideration is given.

How many questions are on the ACRP-PM exam?

The ACRP-PM exam consists of 60 multiple-choice questions. Of these, 50 are scored and 10 are unscored pretest items being evaluated for future use. Pretest items are not identified to candidates and do not affect your score. You have 90 minutes to complete the exam.

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

The passing scaled score is 600 out of a maximum of 800. One point is granted per correct answer with no penalty for incorrect answers. Your raw score is converted to a scaled score. The exam is not scored on a curve, and there is no predetermined number of candidates permitted to pass.

How much does the ACRP-PM exam cost?

The ACRP-PM exam fee is $250 for ACRP members and $300 for non-members. There is no separate application fee for the ACRP-PM specialty exam. ACRP membership costs $160/year, so joining before applying saves you money if you are not already a member.

When can I take the ACRP-PM exam?

ACRP offers two testing windows per year: Spring (February 15 - May 15) and Fall (July 15 - October 15). Registration for Spring 2026 runs October 20, 2025 through April 30, 2026. Registration for Fall 2026 runs May 20 through September 30, 2026.

What references are tested on the ACRP-PM exam?

The exam is referenced only to ICH guidelines: GCP E6(R2), E2A (Expedited Reporting), E8(R1) (General Considerations), E9 (Statistical Principles), E11(R1) (Pediatric Population), and the Declaration of Helsinki. No country-specific regulations (FDA, EMA) are tested. Starting Fall 2026, ICH E6(R3) will replace E6(R2).

Does the ACRP-PM require separate recertification?

No, the ACRP-PM specialty designation does not require separate recertification. It renews automatically with your primary ACRP certification (ACRP-CP, CCRC, CCRA, or CPI), which requires recertification every 2 years with continuing education credits.