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According to ICH E6, what is the primary responsibility of the Principal Investigator regarding the conduct of a clinical trial at the investigator site?

Overall accountability for the conduct of the trial at the site

Recruiting the maximum number of participants

Ensuring the sponsor's financial interests are protected

Managing the site's general business operations

to track

2026 Statistics

Key Facts: CPI Exam

125

Total Questions (100 scored)

ACRP CPI Certification page

180 min

Exam Time

ACRP CPI Certification page

600

Passing Scaled Score

ACRP Certification Handbook

$435–$600

Exam Fee Range

ACRP CPI Certification page

3,000 hrs

Experience Requirement

ACRP CPI Eligibility

July 15, 2026

ICH E6(R3) Transition Date

ACRP CPI Certification page

The ACRP CPI exam consists of 125 multiple-choice questions (100 scored, 25 unscored pretest items) to be completed in 180 minutes. A scaled score of 600 is required to pass. Exam fees range from $435 (ACRP member early bird) to $600 (non-member regular registration). Beginning July 15, 2026, the ICH E6(R3) Guideline for Good Clinical Practice replaces E6(R2) across all ACRP examinations.

Sample CPI Practice Questions

Try these sample questions to test your CPI 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, what is the primary responsibility of the Principal Investigator regarding the conduct of a clinical trial at the investigator site?

A.Overall accountability for the conduct of the trial at the site

B.Recruiting the maximum number of participants

C.Ensuring the sponsor's financial interests are protected

D.Managing the site's general business operations

Explanation: ICH E6 GCP states that the investigator is responsible for the conduct of the clinical trial at the trial site. This encompasses oversight of all trial-related activities including participant safety, data integrity, protocol compliance, and regulatory adherence. This overarching accountability cannot be delegated.

2Under ICH E6, when may a Principal Investigator delegate trial-related duties to a sub-investigator or other qualified team member?

A.Only when the PI is on vacation or leave

B.When the delegate is qualified by education, training, and experience, and delegation is documented

C.Whenever the PI determines the task is routine

D.Only with prior written approval from the regulatory authority

Explanation: ICH E6 requires that the investigator should be qualified by education, training, and experience to assume responsibility for the trial, and any delegation must be to appropriately qualified individuals. The delegation must be documented, typically on a delegation of authority log maintained at the site.

3What document serves as the primary reference for investigators regarding the clinical and nonclinical data of an investigational product?

A.The study protocol

B.The Investigator's Brochure

C.The case report form

D.The informed consent document

Explanation: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the product in human subjects. Per ICH E6, the IB provides investigators with the information necessary to understand the rationale for and risks of the proposed study.

4According to ICH E6, the informed consent process must include which of the following?

A.A guarantee that the investigational product will be effective

B.Adequate explanation of the trial and sufficient time for the participant to decide

C.A requirement that participants pass a written comprehension test

D.Signature from a family member in all cases

Explanation: ICH E6 requires that the informed consent process provide subjects with adequate information about the trial in language they can understand, and they must be given sufficient time and opportunity to decide whether to participate. The process must be free from coercion or undue influence.

5Which international ethical guideline, referenced by the ICH E6, establishes ethical principles for medical research involving human subjects?

A.The Nuremberg Code

B.The Declaration of Helsinki

C.The Belmont Report

D.The Common Rule

Explanation: The Declaration of Helsinki, issued by the World Medical Association, is the foundational ethical guideline referenced by ICH E6 for the protection of human subjects in clinical research. It establishes principles including informed consent, risk-benefit assessment, and the primacy of participant welfare.

6Per ICH E6, what is the role of the IRB/IEC in relation to a clinical trial?

A.To recruit study participants on behalf of the investigator

B.To safeguard the rights, safety, and well-being of trial subjects

C.To manage the site budget and contract negotiations

D.To conduct source data verification visits

Explanation: ICH E6 defines the IRB/IEC as an independent body whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial. This is achieved by reviewing and approving the protocol, informed consent form, and other trial documents.

7A serious adverse event (SAE) is defined by ICH E6 as any untoward medical occurrence that at any dose results in which of the following?

A.Any adverse event that resolves within 24 hours

B.Death, life-threatening event, hospitalization, disability, congenital anomaly, or other medically important event

C.Only events directly caused by the investigational product

D.Any event requiring a protocol amendment

Explanation: ICH E6 defines an SAE as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event that may jeopardize the subject.

8What is the purpose of the delegation of authority log in a clinical trial?

A.To document all study participants enrolled

B.To list all trial-related duties delegated by the PI and the individuals authorized to perform them

C.To record the site's financial expenditures

D.To track investigational product shipments

Explanation: The delegation of authority log (also called the delegation log) documents which trial-related duties the PI has delegated to qualified individuals on the study team. It includes the names, roles, delegated tasks, and the dates of delegation, ensuring accountability and traceability of responsibilities.

9According to ICH E6, which of the following is considered an essential document that must be maintained at the investigator site?

A.The sponsor's marketing plan

B.Signed informed consent forms for all participants

C.The monitor's personal travel receipts

D.Press releases about the investigational product

Explanation: ICH E6 lists signed informed consent forms among the essential documents that must be maintained at the investigator/institution site. Essential documents are those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

10What is the primary purpose of a study protocol in a clinical trial?

A.To describe the objectives, design, methodology, statistical considerations, and organization of a trial

B.To serve as the advertising material for participant recruitment

C.To document the monitor's findings during site visits

D.To provide financial projections for the trial

Explanation: The study protocol is the document that describes the objectives, design, methodology, statistical considerations, and organization of a trial. It serves as the foundational document that all trial activities are based upon and must be approved by the IRB/IEC before the trial begins.

About the CPI Exam

The CPI exam certifies physicians and qualified healthcare professionals serving as Principal Investigators on clinical trials. The exam is referenced exclusively to ICH Guidelines and covers scientific concepts, ethics, GCP, regulatory compliance, site management, and data management across six content domains.

Questions

125 scored questions

Time Limit

3 hours (180 minutes)

Passing Score

Scaled score of 600

Exam Fee

$435–$600 (varies by membership and registration period) (ACRP (Association of Clinical Research Professionals))

CPI Exam Content Outline

15%

Scientific Concepts and Research Design

Protocol development, Investigator's Brochure review, research methodology, inclusion/exclusion criteria, and hypothesis generation

22%

Ethical and Participant Safety Considerations

Informed consent, IRB/IEC oversight, Declaration of Helsinki, SAE/SUSAR reporting, vulnerable populations, and participant safety monitoring

12%

Product Development and Regulation

Investigational product lifecycle, regulatory submissions, expedited safety reporting (ICH E2A), and audit/inspection processes

21%

Clinical Trial Operations (GCP)

ICH E6 GCP compliance, PI responsibilities, site feasibility, protocol amendments, delegation of authority, and sponsor-investigator agreements

17%

Study and Site Management

Investigational product management, equipment and supplies, site operations, staff qualification and training, and participant visit oversight

13%

Data Management and Informatics

Source documentation, CRF/eCRF review, data integrity, query resolution, protected health information, and record retention

How to Pass the CPI 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 (varies by membership and registration period)

Keys to Passing

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

CPI Study Tips from Top Performers

1Prioritize ICH E6 GCP thoroughly — it is the single most-referenced document and underpins questions across all six domains

2Weight your study to the blueprint: Ethics (22%) and Clinical Trial Operations (21%) together cover 43% of scored content

3Master PI responsibilities under ICH GCP, including delegation, oversight of consent, safety reporting, and essential document maintenance

4Study ICH E2A for SAE/SUSAR expedited reporting timelines — these are frequently tested and require precise knowledge

5Practice scenario-based questions that test your decision-making as a PI, not just memorization of guideline text

Frequently Asked Questions

How many questions are on the CPI exam?

The CPI exam consists of 125 multiple-choice questions. Of these, 100 are scored and 25 are unscored pretest items used for future exam development. Pretest items are not identified to candidates. You have 180 minutes (3 hours) to complete all 125 questions.

What score do I need to pass the CPI exam?

The passing scaled score for the CPI exam is 600. Raw scores (number correct) are converted to a scaled score by PSI. There is no penalty for guessing, so answer every question.

Who is eligible to take the CPI exam?

Candidates must hold a doctoral-level degree (MD, DO, MBBS, MBChB, DDS, PhD, PharmD, DNP) or be a licensed PA or NP who has served as PI. You need 3,000 hours of verifiable clinical research experience and proof of PI or Sub-I employment for at least 2 of the most recent 5 years.

How much does the CPI exam cost in 2026?

Fees include both application and exam fees. ACRP member early bird: $435. Non-member early bird: $485. ACRP member regular: $460. Non-member regular: $600. Spring 2026 testing runs February 15 to May 15; Fall 2026 testing runs July 15 to October 15.

What references does the CPI exam test?

The CPI exam is referenced exclusively to ICH Guidelines, including ICH E6 (GCP), E2A (expedited reporting), E8 (general considerations), E9 (statistical principles), E11 (pediatric trials), and the Declaration of Helsinki. No country-specific regulations (FDA, EMA) are tested.

What is changing with the CPI exam in 2026?

Beginning July 15, 2026, the ICH E6(R3) Guideline for Good Clinical Practice will replace E6(R2) across all ACRP examinations, including CPI. Candidates testing before that date will be assessed on E6(R2); those testing on or after July 15 will be assessed on E6(R3).

How should I study for the CPI exam?

Focus your study on ICH E6 GCP guidelines, which underpin most questions. Weight your preparation to the content outline: Ethics (22%) and Clinical Trial Operations (21%) together cover 43% of scored questions. Review the official Exam Content Outline and all referenced ICH guidelines. Use practice questions to identify knowledge gaps.