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Exam Review

Key Facts: CHRC Exam

120

Total Questions

100 scored + 20 pretest

2 hrs

Time Limit

For 120 questions

$350

Exam Fee (Members)

$450 non-members

7

Content Domains

Per CCB DCO

2 yrs

Certification Period

40 CEUs to renew

20

CEUs Required

Within 12 months of exam

The CHRC exam has 120 multiple-choice questions (100 scored, 20 unscored pretest items) with a 2-hour time limit. The exam covers 7 content domains spanning research compliance program operations. Candidates need 1 year of compliance experience and 20 CCB CEUs. The exam is administered by PSI at testing centers or via remote proctoring. Certification is valid for 2 years with 40 CEU renewal requirement.

Sample CHRC Practice Questions

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

1Under the Common Rule (45 CFR 46), which federal office is primarily responsible for overseeing the protection of human subjects in research funded by HHS?
A.Food and Drug Administration (FDA)
B.Office of Research Integrity (ORI)
C.Office for Human Research Protections (OHRP)
D.Office for Civil Rights (OCR)
Explanation: The Office for Human Research Protections (OHRP) within HHS is responsible for overseeing compliance with the Common Rule (45 CFR 46) for the protection of human subjects in research conducted or supported by HHS. The FDA regulates research involving FDA-regulated products, ORI handles research misconduct, and OCR enforces HIPAA privacy regulations.
2An IRB must have at least how many members to be properly constituted under the Common Rule?
A.Three members
B.Five members
C.Seven members
D.Nine members
Explanation: Under 45 CFR 46.107, an IRB must have at least five members with varying backgrounds to promote complete and adequate review of research activities. The membership must include at least one member whose primary concerns are in scientific areas, one whose primary concerns are in nonscientific areas, and one member not otherwise affiliated with the institution.
3Which of the following is NOT one of the three ethical principles outlined in the Belmont Report?
A.Respect for Persons
B.Beneficence
C.Justice
D.Confidentiality
Explanation: The Belmont Report identifies three fundamental ethical principles for research involving human subjects: Respect for Persons (autonomy and protection of those with diminished autonomy), Beneficence (maximizing benefits and minimizing harm), and Justice (fair distribution of research burdens and benefits). Confidentiality is an important aspect of research ethics but is not one of the three Belmont principles.
4A researcher plans to conduct a chart review of de-identified patient records with no patient contact. What is the most appropriate IRB determination?
A.Full board review required
B.The activity may not constitute human subjects research
C.Expedited review required
D.Exempt status with continuing review
Explanation: If the researcher is reviewing only de-identified records and there is no interaction with subjects or access to identifiable private information, the activity may not meet the definition of human subjects research under the Common Rule. The key determination is whether the data includes identifiers that could link back to individuals. If truly de-identified per the applicable standards, the activity falls outside the scope of the Common Rule's requirements.
5Under the revised Common Rule (2018 Requirements), which category of research is eligible for exemption when it involves benign behavioral interventions with adult subjects?
A.Exempt Category 1
B.Exempt Category 3
C.Exempt Category 2
D.Exempt Category 4
Explanation: Under the revised Common Rule, Exempt Category 3 covers research involving benign behavioral interventions in conjunction with the collection of information from adult subjects through verbal or written responses or audiovisual recording, provided the subjects prospectively agree and certain conditions about identifiability are met. Category 1 covers educational settings, Category 2 covers surveys/interviews/observation, and Category 4 covers secondary research with identifiable information.
6What is the primary purpose of a code of conduct in a research compliance program?
A.To replace federal regulations with institutional policies
B.To serve as a legal defense in the event of a government investigation
C.To establish organizational expectations for ethical behavior and compliance
D.To fulfill continuing education requirements for researchers
Explanation: A code of conduct establishes the organization's expectations for ethical behavior, integrates the institution's mission, vision, and values, and provides a framework for compliance with laws and regulations. It is not a replacement for federal regulations, a legal defense mechanism, or a continuing education tool, although it may support each of these indirectly.
7A pharmaceutical company is sponsoring a clinical trial at your institution. The principal investigator holds $50,000 in stock in the sponsoring company. What is the FIRST step the compliance officer should take?
A.Immediately remove the PI from the study
B.Ensure the conflict is disclosed and managed through the institution's conflict of interest process
C.Report the conflict to the FDA
D.Allow the PI to continue without intervention since the amount is below the reporting threshold
Explanation: The first step is to ensure the financial conflict of interest is properly disclosed and managed through the institution's established COI process. The institution's COI committee should evaluate the conflict, determine whether it can be managed, reduced, or eliminated, and implement a management plan if appropriate. Immediate removal may not be necessary if the conflict can be managed, and $50,000 exceeds the PHS significant financial interest threshold of $5,000.
8Under PHS regulations (42 CFR Part 50, Subpart F), what is the threshold for a Significant Financial Interest (SFI) that must be reported?
A.Any financial interest regardless of value
B.Financial interests exceeding $10,000
C.Financial interests exceeding $5,000
D.Financial interests exceeding $25,000
Explanation: Under PHS regulations (42 CFR Part 50, Subpart F), a Significant Financial Interest is defined as a financial interest that reasonably appears to be related to the investigator's institutional responsibilities and exceeds $5,000 in value (including salary, royalties, or other payments from a publicly traded entity, or any equity interest in a non-publicly traded entity). The $5,000 threshold applies to the aggregate value over the preceding 12-month period.
9Which federal database should be checked to verify that research personnel are not excluded from participation in federally funded programs?
A.ClinicalTrials.gov
B.FDA Approved Drug Products Database
C.NIH Reporter
D.System for Award Management (SAM) Exclusion Database
Explanation: The System for Award Management (SAM) Exclusion Database (formerly the Excluded Parties List System) must be checked to ensure that individuals and entities involved in research are not excluded or debarred from participating in federally funded programs. Organizations should routinely screen employees, researchers, vendors, and contractors against this database. ClinicalTrials.gov is for trial registration, NIH Reporter tracks funded grants, and the FDA database lists approved drugs.
10What is the purpose of the Federal Wide Assurance (FWA) in human subjects research?
A.To provide liability insurance for research institutions
B.To register individual research protocols with OHRP
C.To commit the institution to comply with the Common Rule requirements for protecting human subjects
D.To certify that an IRB has reviewed and approved a specific study
Explanation: A Federal Wide Assurance (FWA) is a commitment by an institution that it will comply with the requirements of the Common Rule (45 CFR 46) for the protection of human research subjects. Any institution engaged in non-exempt human subjects research conducted or supported by HHS must hold an approved FWA. The FWA designates which IRB(s) will review research and commits to the ethical principles of the Belmont Report.

About the CHRC Exam

The CHRC certification validates expertise in healthcare research compliance, covering IRB operations, human subjects protection, FDA regulations, GCP guidelines, research billing compliance, grants management, and research misconduct investigations.

Exam sponsor: Compliance Certification Board (CCB) / HCCA. The requirements and fees below concern the certification or admission exam, separate from our free practice resources.

Questions

120 questions

Time Limit

2 hours

Passing Score

Scaled score (criterion-referenced)

Exam / Certification Fees

$350 members / $450 non-members

Exam sponsor website

Fees, eligibility, and exam policies can change. Confirm them with the exam sponsor before applying or paying.

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.

17%

Standards, Policies, and Procedures

Research compliance policies, code of conduct, FDA/OHRP/USDA/ORI regulatory requirements, conflict of interest, and human/animal subject protections

15%

Compliance Program Administration

Program management, budgeting, staffing, risk assessment, governance board oversight, annual work plans, and regulatory monitoring

8%

Screening and Evaluation

Conflict of interest disclosure, background checks, excluded individuals monitoring, and compliance in job descriptions and evaluations

18%

Communication, Education, and Training

Regulatory guidance dissemination, compliance culture, role-specific training, participation tracking, and board oversight training

20%

Monitoring, Auditing, and Internal Reporting

Compliance audits, anonymous reporting systems, research billing audits, grants management, corrective action tracking, and trend analysis

8%

Enforcement, Discipline, and Incentives

Proportionate disciplinary action, consistent enforcement, compliance incentives, and exclusion verification

14%

Investigations and Remedial Measures

Root cause analysis, corrective action plans, mandated reporting, government inquiry cooperation, and legal counsel involvement

Preparing for the CHRC Exam

What You Need to Know

  • Passing score: Scaled score (criterion-referenced)
  • Exam length: 120 questions
  • Time limit: 2 hours
  • Exam / certification fees: $350 members / $450 non-members 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

CHRC: Suggested Study Strategy

1Focus heavily on Monitoring, Auditing, and Internal Reporting (20% of exam) — master research billing compliance, audit methodologies, and corrective action tracking
2Study the Common Rule (45 CFR 46) thoroughly including the 2018 revised requirements for exemptions, continuing review changes, and single IRB requirements
3Learn all 7 elements of an effective compliance program as outlined in the OIG Compliance Program Guidance — these concepts appear across multiple domains
4Practice applying regulations to real-world scenarios — the exam includes recall, application, and analysis questions that test practical compliance decision-making
5Review FDA regulations (21 CFR Parts 50, 56, 312, 812) for clinical trials, including IND/IDE requirements, adverse event reporting timelines, and inspection processes

Frequently Asked Questions

What is the CHRC certification?

The CHRC (Certified in Healthcare Research Compliance) is a professional certification offered by the Compliance Certification Board (CCB) through HCCA. It validates expertise in healthcare research compliance, including IRB oversight, human subjects protection, FDA regulations, GCP guidelines, research billing compliance, grants management, and misconduct investigations. The certification demonstrates proficiency across 7 compliance domains.

How many questions are on the CHRC exam?

The CHRC exam contains 120 multiple-choice questions, but only 100 are scored. The remaining 20 are unscored pretest items used to validate future questions. These pretest items are mixed throughout the exam and are not identified, so you should answer every question to the best of your ability. You have 2 hours to complete all 120 questions.

What are the eligibility requirements for the CHRC exam?

To sit for the CHRC exam, you must have at least 1 year in a full-time compliance position or 1,500 hours of direct compliance job duties earned within 2 years before your application date. Your duties must relate to the CHRC Detailed Content Outline. You also need 20 CCB continuing education units (CEUs) earned within 12 months, with at least 10 from live training events.

How much does the CHRC exam cost?

The CHRC exam application fee is $350 for HCCA members and $450 for non-members. A $75 non-refundable application fee applies to all re-exam requests. If you fail two attempts within 180 days, you must wait 180 days before retaking. Certification renewal costs $145 for members and $265 for non-members every 2 years, requiring 40 CCB CEUs.

How should I prepare for the CHRC exam?

Start by downloading the CHRC Candidate Handbook, which includes the Detailed Content Outline (DCO) covering all 7 exam domains. Study the Common Rule (45 CFR 46), FDA regulations, HIPAA research provisions, ICH-GCP guidelines, and research misconduct regulations. HCCA offers a Healthcare Research Compliance Academy, conferences, and webinars. Use free practice questions to test your knowledge across all domains.