100+ Free CCRA Practice Questions

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A CRA identifies that a subject was enrolled in a trial despite not meeting the inclusion criteria. This is an example of:

Normal clinical trial variability

An investigator's professional judgment call

A protocol deviation involving eligibility criteria

An adverse event

to track

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2026 Statistics

Key Facts: CCRA Exam

125

Total Questions

ACRP (100 scored + 25 pretest)

3 hours

Exam Time

ACRP Certification Handbook

600

Passing Scaled Score

ACRP scoring (200-800 scale)

$435–$600

Exam Fee

ACRP (varies by membership/timing)

~70%

First-Attempt Pass Rate

ACRP annual report data

3,000 hrs

Experience Required

ACRP eligibility criteria

ACRP's CCRA exam uses 125 total items (100 scored + 25 pretest), with a 3-hour time limit and a passing scaled score of 600 on a 200-800 scale. Fees range from $435 to $600 depending on ACRP membership and registration timing. Content spans six domains: Scientific Concepts (8%), Ethical/Safety (20%), Product Development/Regulation (10%), Clinical Trial Operations/GCPs (25%), Study/Site Management (25%), and Data Management (12%). The exam references ICH guidelines exclusively.

Sample CCRA Practice Questions

Try these sample questions to test your CCRA 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), Good Clinical Practice (GCP) is an international ethical and scientific quality standard for:

A.Manufacturing pharmaceutical products

B.Designing, conducting, recording, and reporting clinical trials involving human subjects

C.Marketing approved drugs to healthcare providers

D.Regulating the sale of medical devices

Explanation: ICH E6(R2) defines GCP as an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with GCP provides public assurance that the rights, safety, and well-being of trial subjects are protected.

2What is the PRIMARY purpose of informed consent in a clinical trial?

A.To protect the sponsor from legal liability

B.To ensure the subject voluntarily agrees to participate after understanding the trial's purpose, procedures, risks, and benefits

C.To fulfill a regulatory requirement with no direct impact on the subject

D.To allow the investigator to enroll subjects more quickly

Explanation: Informed consent ensures that a subject voluntarily decides to participate in a clinical trial after being fully informed about the trial's purpose, procedures, potential risks and benefits, and their right to withdraw at any time. It is a fundamental ethical requirement rooted in the Declaration of Helsinki and ICH GCP.

3During a routine monitoring visit, a CRA discovers that the investigator has not been reporting adverse events within the protocol-specified timelines. The CRA should FIRST:

A.Report the finding to the IRB/IEC directly

B.Document the finding and discuss it with the investigator to understand the cause and develop a corrective action plan

C.Immediately close the site to further enrollment

D.Ignore the issue if the adverse events are not serious

Explanation: The CRA should first document the finding in the monitoring report and discuss it with the investigator to understand why the timelines were missed and develop a corrective action plan (CAPA). This collaborative approach addresses the issue while maintaining the CRA-investigator relationship and ensuring proper documentation.

4According to ICH GCP, who is ultimately responsible for the medical care of trial subjects at the investigational site?

A.The clinical research coordinator

B.The principal investigator

C.The sponsor's medical monitor

D.The Institutional Review Board

Explanation: According to ICH E6(R2), the investigator, who should be a qualified physician or dentist, is responsible for all trial-related medical decisions and the medical care of trial subjects. The PI must ensure that adequate medical care is provided for any adverse events, including clinically significant laboratory values.

5What document contains the clinical and nonclinical data about the investigational product that is relevant to the study of the product in human subjects?

A.The case report form

B.The Investigator's Brochure

C.The monitoring plan

D.The statistical analysis plan

Explanation: The Investigator's Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) relevant to the study in humans. It provides investigators with the information needed to understand the rationale for the proposed trial and to manage subjects safely.

6A CRA is conducting source data verification (SDV) during a monitoring visit. SDV involves comparing:

A.The protocol with the IRB approval letter

B.Data recorded in the CRF/eCRF with original source documents at the site

C.The investigator's CV with the delegation log

D.The sponsor's budget with the site's financial records

Explanation: Source data verification is the process of comparing data entered in the case report form (CRF) or electronic CRF (eCRF) with the original source documents at the site, such as medical records, lab reports, and patient diaries. SDV ensures the accuracy, completeness, and reliability of trial data.

7According to ICH GCP, the IRB/IEC must review and approve the protocol and informed consent form BEFORE:

A.The sponsor finalizes the study budget

B.The first subject is enrolled at the site

C.The CRA conducts the first monitoring visit

D.The investigator submits their CV to the sponsor

Explanation: ICH GCP requires that the IRB/IEC review and provide written approval of the trial protocol, informed consent form, and other relevant documents before the trial begins at the site. No subject may be enrolled until IRB/IEC approval is documented.

8What is a Serious Adverse Event (SAE) as defined by ICH guidelines?

A.Any untoward medical occurrence in a trial subject

B.An adverse event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability, or is a congenital anomaly/birth defect

C.An adverse event that is expected based on the Investigator's Brochure

D.An adverse event that is mild in severity and self-limiting

Explanation: ICH defines a Serious Adverse Event 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.

9The delegation log at a clinical trial site serves to:

A.Track patient visit schedules throughout the trial

B.Document all individuals authorized by the PI to perform trial-related tasks and their specific delegated responsibilities

C.Record the financial agreements between the sponsor and site

D.List the equipment calibration dates for all lab instruments

Explanation: The delegation log (also called the delegation of authority log) is a document signed by the PI that identifies all individuals authorized to perform trial-related duties and specifies which tasks each person is delegated to perform. It ensures accountability and compliance with ICH GCP requirements for adequate staffing and oversight.

10According to ICH GCP, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated according to:

A.The sponsor's marketing plan

B.The protocol, GCP, and applicable regulatory requirements

C.The site's internal operating procedures only

D.The investigator's personal preferences

Explanation: ICH E6(R2) states that the sponsor should implement a system to manage quality of all aspects of the trial. The sponsor's QA/QC systems must ensure compliance with the protocol, GCP guidelines, and applicable regulatory requirements through written standard operating procedures.

About the CCRA Exam

The ACRP CCRA certification validates proficiency in clinical trial monitoring and management. The exam covers ICH Good Clinical Practice guidelines, informed consent, adverse event reporting, site monitoring, investigational product accountability, and data management across global clinical research settings.

Questions

100 scored questions

Time Limit

3 hours

Passing Score

Scaled score 600

Exam Fee

$435–$600 (ACRP)

CCRA Exam Content Outline

Scientific Concepts and Research Design

Protocol components, study design rationale, product development plans, and research methodology

20%

Ethical and Participant Safety Considerations

Informed consent, IRB/IEC oversight, adverse event reporting, safety monitoring, and participant rights

10%

Product Development and Regulation

Drug and device development lifecycle, regulatory submissions, and ICH guideline application

25%

Clinical Trial Operations (GCPs)

Delegation of responsibilities, protocol amendments, investigator oversight, SOPs, and audit readiness

25%

Study and Site Management

Site monitoring visits, investigational product management, communication, non-compliance, and vendor oversight

12%

Data Management and Informatics

Source data verification, CRF completion, data queries, database lock procedures, and electronic systems

How to Pass the CCRA Exam

What You Need to Know

Passing score: Scaled score 600
Exam length: 100 questions
Time limit: 3 hours
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

CCRA Study Tips from Top Performers

1Clinical Trial Operations + Study/Site Management together make 50% of the exam — prioritize these domains

2Know ICH E6(R2) GCP inside and out: it is the primary reference for all exam questions

3Master the monitoring visit lifecycle: pre-study, initiation, interim/routine, and close-out visits

4Practice informed consent scenarios including re-consent triggers and documentation requirements

5Study adverse event reporting timelines and the difference between AEs, SAEs, and SUSARs

Frequently Asked Questions

How many questions are on the CCRA exam?

The CCRA exam has 125 total multiple-choice questions: 100 scored items and 25 unscored pretest items. Pretest items are not identified to candidates and do not affect your score.

How long is the CCRA exam?

ACRP allows a maximum of 3 hours (180 minutes) to complete all 125 questions on the CCRA exam.

What score do I need to pass the CCRA exam?

You need a scaled score of 600 or higher on a 200-800 scale to pass the CCRA. Raw scores are converted to scaled scores using psychometric methods; the exam is not scored on a curve.

How much does the CCRA exam cost?

Total fees range from $435 to $600 depending on ACRP membership status and early-bird vs. regular registration. ACRP members with early-bird registration pay $435; non-members at regular registration pay up to $600.

What experience do I need for CCRA eligibility?

ACRP requires 3,000 hours of verifiable work experience in human subject research. There is no specific degree requirement. Experience must be paid, contractual, and verifiable by your employer.

How should I prepare for the CCRA exam in 2026?

Focus on the two largest domains: Clinical Trial Operations and Study/Site Management (25% each, 50% total). Study the ICH E6(R2) guidelines thoroughly and note that E6(R3) replaces E6(R2) starting July 15, 2026. Practice scenario-based questions on monitoring visits, informed consent, and adverse event reporting.