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Exam Review

Key Facts: CCRA Exam

125

Total exam items

ACRP June 2026 handbook; 100 scored + 25 pretest

180 minutes

Time limit

ACRP CCRA programme, checked 2026-10-18

600

Passing scaled score

ACRP June 2026 handbook

$435–$600

Initial total fees

ACRP CCRA fee table, checked 2026-10-18

E6(R3)

Current GCP reference

ACRP change effective July 15, 2026

3,000 hours

CRA experience before an accepted substitution

ACRP June 2026 handbook

CCRA has 125 multiple-choice items, including 100 scored and 25 unscored pretest items, in 180 minutes. Passing requires a scaled score of 600. The current ECO weights are 12%, 18%, 14%, 18%, 25% and 13%. ACRP uses E6(R3) from July 15, 2026; country-specific FDA or EMA frameworks are not tested. Initial fees are $435–$600 by membership and registration timing.

Sample CCRA Practice Questions

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

1According to ICH E6(R3), Good Clinical Practice (GCP) is an international ethical, scientific and quality standard for:
A.Manufacturing pharmaceutical products
B.Planning, conducting, recording and reporting clinical trials involving human participants
C.Marketing approved drugs to healthcare providers
D.Regulating the sale of medical devices
Explanation: ICH E6(R3) describes GCP as an international, ethical, scientific and quality standard for the conduct of trials that involve human participants, and its glossary defines it as a standard for the planning, initiating, performing, recording, oversight, evaluation, analysis and reporting of clinical trials. Compliance assures that participants' rights, safety and well-being are protected and that results are reliable.
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: Under ICH E6(R3) 2.7.1(a), a qualified physician or, where appropriate, a qualified dentist (or other qualified healthcare professional where local rules allow) who is an investigator or sub-investigator is responsible for trial-related medical care and decisions. 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(R3) section 3.10 states that the sponsor should implement an appropriate system to manage quality throughout all stages of the trial process. 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.

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

Questions

125 questions

Time Limit

3 hours

Passing Score

Scaled score 600 (maximum 800)

Exam / Certification Fees

$435–$600

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.

12%

Scientific Concepts and Research Design

Protocol and product information, eligibility rationale, design, endpoints, treatment assignment and development stages.

18%

Ethical and Participant Safety Considerations

Consent, confidentiality, safety, recruitment, discontinuation, vulnerability, conflicts and misconduct.

14%

Regulatory Requirements

IRB/IEC roles and communications, protocol amendments, authority reporting and trial status.

18%

Clinical Trial Operations (GCP)

Monitoring plans, responsibilities, risk and data governance, feasibility, CAPA, audits and inspections.

25%

Study and Site Management Activities

Communication, equipment, products, samples, contracts, delegation, visits and essential records.

13%

Data Quality

Source access, data tools, queries, pharmacovigilance, retention, verification and critical data.

Preparing for the CCRA Exam

What You Need to Know

  • Passing score: Scaled score 600 (maximum 800)
  • Exam length: 125 questions
  • Time limit: 3 hours
  • Exam / certification fees: $435–$600 Official sources

Using Our Practice Resources

  • Work through all 100 available questions
  • Review every answer and explanation
  • Track weak areas and revisit them
  • Use our AI tutor for tough concepts

CCRA: Suggested Study Strategy

1Use the current official CCRA ECO weights: 12%, 18%, 14%, 18%, 25%, 13%.
2Study E6(R3), E2A, E8(R1), E9/E9(R1), E11(R1) and the Declaration of Helsinki from ACRP’s reference list.
3Separate investigator care, sponsor oversight, monitor verification and independent review responsibilities.
4Apply actual protocol instructions rather than invented universal 24-hour, SDV percentage or storage rules.
5Use missed questions to identify knowledge and applied-task gaps, then verify improvement with fresh scenarios.

Frequently Asked Questions

How many questions are on the CCRA exam?

The ACRP CCRA examination has 125 multiple-choice items: 100 scored and 25 unscored pretest items. The pretest items are not identified and do not affect the score.

How long is the CCRA exam?

The CCRA time limit is 180 minutes, or three hours, for all 125 items.

What score passes the CCRA exam?

ACRP requires a scaled score of 600 and states a maximum score of 800. The handbook does not publish a fixed raw passing percentage; the examination is not scored on a curve.

What does the CCRA exam cost?

The current ACRP table lists initial totals of $435 member/$485 nonmember for early bird and $460 member/$600 nonmember for regular registration. Application and examination components are included; confirm the current category before applying.

What experience is required for CCRA?

The June 2026 handbook requires 3,000 hours performing CRA essential duties with verifiable employment and supporting resume/job-description evidence. One accepted substitution for active ACRP certification or an approved accredited clinical research education programme can reduce the required qualifying work to 1,500 hours. Internships, volunteer work, education-programme hours and experience older than ten years do not count.

Which GCP revision should I study for CCRA in late 2026?

ACRP replaced E6(R2) with E6(R3) for examinations beginning July 15, 2026. Use ACRP’s current CCRA ECO and linked ICH/Helsinki references. The ECO weights are 12%, 18%, 14%, 18%, 25% and 13%; Clinical Trial Operations plus Study/Site Management total 43%.

How does CCRA retesting work?

The June 2026 handbook permits retesting 60 days after the original appointment or in the next available window. Eligible immediate retests pay the exam fee; after two failed attempts or expiry of the one-year eligibility, a new application and current fees are required. Confirm appointment eligibility with ACRP.