- How the CHRC Blueprint Is Built
- Domain Weights at a Glance
- Domain 1: Standards, Policies, and Procedures (17%)
- Domain 2: Compliance Program Administration (15%)
- Domain 3: Screening and Evaluation (8%)
- Domain 4: Communication, Education, and Training (18%)
- Domain 5: Monitoring, Auditing, and Internal Reporting Systems (20%)
- Domain 6: Enforcement, Discipline, and Incentives (8%)
- Domain 7: Investigations and Remedial Measures (14%)
- Exam Format and Logistics That Shape Your Study
- Sequencing the Domains in Your Study Plan
- Frequently Asked Questions
- The Certified in Healthcare Research Compliance (CHRC) outline has seven domains, and Monitoring, Auditing, and Internal Reporting Systems is the largest at...
- Communication, Education, and Training (18%) and Standards, Policies, and Procedures (17%) together make up over a third of scored questions.
- The exam has 120 questions: 100 scored plus 20 unidentified unscored pretest items, in two hours.
- Screening and Evaluation and Enforcement, Discipline, and Incentives are each 8%, but should not be skipped.
How the CHRC Blueprint Is Built
The Certified in Healthcare Research Compliance (CHRC) credential is issued by the independent Compliance Certification Board (CCB), with the Health Care Compliance Association (HCCA) as the governing body. Every question on the exam traces back to a published document called the Detailed Content Outline (DCO), which appears on pages 22-24 of the CHRC Candidate Handbook. If you are new to the credential itself, start with What Is CHRC Certification? before digging into the blueprint.
The DCO organizes the exam into seven domains. The percentages published for each domain equal the number of scored items out of 100, so a 20% domain means 20 scored questions. That is a useful way to think about the blueprint: it is a literal question budget, not a vague emphasis guide.
One caution on sourcing. The official outline landing page and the handbook PDFs are the only authoritative references for the domain names. An older archived HCCA handbook for a different credential (the CHR Candidate Handbook) uses a different blueprint and should not be mixed into your preparation. Several third-party sites also abbreviate domain headings, which can hide how broad a domain really is. The full names are used throughout this guide.
Domain Weights at a Glance
| Domain | Official Name | Weight (scored items of 100) |
|---|---|---|
| 1 | Standards, Policies, and Procedures | 17% |
| 2 | Compliance Program Administration | 15% |
| 3 | Screening and Evaluation of Researchers, Employees, Physicians, Sponsors, Vendors, Contractors, and Others | 8% |
| 4 | Communication, Education, and Training | 18% |
| 5 | Monitoring, Auditing, and Internal Reporting Systems | 20% |
| 6 | Enforcement, Discipline, and Incentives | 8% |
| 7 | Investigations and Remedial Measures | 14% |
Notice the shape of the distribution. Domains 1, 4, and 5 account for 55% of the scored exam. Domains 3 and 6 together account for just 16%. That asymmetry should drive how you allocate hours, but it should not drive you to ignore the small domains, since a research-compliance question can blend several domains in a single scenario.
Domain 1: Standards, Policies, and Procedures (17%)
This domain is the regulatory and policy backbone of the exam. Candidates are expected to know which rules govern human subjects research, research integrity, and research billing, and how an institution translates those rules into written standards. The agency landscape matters here: the official outline covers roles of bodies such as FDA, USDA, ORI, OCR, and OHRP. NIH is an issuer-recommended preparation resource, not a separately weighted domain, so treat NIH policy as supporting context rather than a standalone study block.
Standards, Policies, and Procedures
Know the regulators, what each one oversees, and how institutional policy implements their requirements.
- Which agency has authority over which research activity (FDA for regulated products, OHRP for human subjects protections under federal funding, ORI for research misconduct, OCR for privacy and civil rights matters, USDA for animal welfare)
- How written policies, SOPs, and codes of conduct are developed, approved, updated, and communicated
- Research billing and coverage analysis fundamentals, including why clinical trial charges must be matched to the correct payer
- Conflict of interest, informed consent, and data integrity standards as policy subjects
Questions in this domain tend to ask which standard applies or which document should exist, so precision with agency roles pays off. For a quick consolidation of facts you will want to memorize, pair this section with the CHRC Cheat Sheet.
Domain 2: Compliance Program Administration (15%)
Where Domain 1 asks what the rules are, Domain 2 asks how a research compliance program is run. Expect questions on program structure, oversight responsibilities, resources, and the relationship between the compliance function and institutional leadership and governing bodies.
Compliance Program Administration
The mechanics of building, staffing, and governing a research compliance program.
- The role and independence of the compliance officer and committees
- Risk assessment and work planning for research activities
- Reporting lines, board and executive engagement, and program effectiveness measures
- Coordination with IRBs, grants and contracts offices, and clinical operations
Scenario questions here often hinge on who should own a decision. A common trap is selecting an answer that has the compliance officer performing an operational function that belongs to research management. Think in terms of oversight versus execution.
Domain 3: Screening and Evaluation (8%)
The full heading of this domain is long: Screening and Evaluation of Researchers, Employees, Physicians, Sponsors, Vendors, Contractors, and Others. The breadth of that title is the lesson. Candidates must consider screening not only for staff but for every party that touches the research enterprise.
Screening and Evaluation
Due diligence on people and organizations before and during their involvement in research.
- Exclusion and debarment checks and why ongoing screening matters
- Background and credential verification for investigators and staff
- Evaluating sponsors, vendors, and contractors for compliance risk
- Handling findings from screening, including conflicts of interest disclosures
At 8%, this is a modest slice, but the questions are usually concrete and answerable once you know the screening concepts, which makes it a high-return domain per hour of study.
Domain 4: Communication, Education, and Training (18%)
The second-largest domain deserves serious time. It covers how a research compliance program gets its message to the people who need it and how it confirms the message landed. This is the domain where candidates who come from pure audit or legal backgrounds sometimes lose points, because it rewards program-design judgment.
Communication, Education, and Training
Designing and delivering role-appropriate compliance education and open communication channels.
- Tailoring training content to audience, risk, and role
- Onboarding versus refresher training and tracking completion
- Hotlines, open-door policies, and non-retaliation messaging
- Measuring training effectiveness and updating content after regulatory change
Domain 5: Monitoring, Auditing, and Internal Reporting Systems (20%)
This is the largest domain on the exam, worth 20 of the 100 scored questions. The full heading includes "Internal Reporting Systems," and that phrase is easy to lose when sources shorten it to "Monitoring and Auditing." Reporting mechanisms are tested here, not just audit technique.
Monitoring, Auditing, and Internal Reporting Systems
How compliance is verified on an ongoing basis and how concerns reach the right people.
- The difference between ongoing monitoring and periodic auditing, and when each is appropriate
- Risk-based audit planning, sampling, and documentation of findings
- Research billing audits, including matching charges to clinical trial coverage determinations
- Reporting channels, intake, triage, and tracking of reports
- Using audit results to drive corrective action
Because of its weight, this is the domain where extra practice repays itself most. Working through scenario questions that ask you to choose between monitoring, auditing, and investigating is especially valuable, and you can drill that distinction on the CHRC practice test site.
Domain 6: Enforcement, Discipline, and Incentives (8%)
Domain 6 covers the consequence side of a compliance program: consistent discipline, and positive incentives that reinforce good behavior. Like Domain 3, it is 8%, and its questions tend to reward understanding principles over memorizing detail.
Enforcement, Discipline, and Incentives
Making expectations real through consistent consequences and recognition.
- Consistency and fairness in applying disciplinary measures regardless of seniority or grant funding
- Documentation of disciplinary actions
- Incorporating compliance performance into evaluations and incentives
- The interaction between enforcement and non-retaliation protections
A reliable heuristic: when an answer option treats a high-profile, high-funded investigator more leniently than a junior employee, it is almost certainly wrong.
Domain 7: Investigations and Remedial Measures (14%)
The final domain covers what happens after a problem is identified. It asks how to respond to a credible allegation, how to preserve evidence, when to involve other parties, and how to fix root causes so the problem does not recur.
Investigations and Remedial Measures
Responding to reported or detected noncompliance in a structured, defensible way.
- Initial assessment and triage of allegations, including research misconduct questions
- Investigation planning, interviews, documentation, and confidentiality
- Determining when external reporting or disclosure obligations are triggered
- Corrective and preventive action plans, including repayment and process changes
Domains 5 and 7 are closely linked. A finding surfaced by a research billing audit in Domain 5 becomes an investigation and remediation question in Domain 7, so study them as a connected chain.
Exam Format and Logistics That Shape Your Study
The exam consists of 120 multiple-choice questions delivered in two hours, in English only. Of those 120, 100 are scored and 20 are unidentified unscored pretest questions, so you cannot tell which items count and should treat every question seriously. Testing is administered through PSI, with options for test-center computer delivery, remote proctoring, and paper-and-pencil administration at selected HCCA/SCCE events. The exam is closed book, and handheld calculators are prohibited under the remote-testing rules. The passing standard is set by an Angoff process applied to the scored questions; a fixed numerical cut score has not been publicly verified, and details are discussed in CHRC Passing Score 2026.
| Item | Detail |
|---|---|
| Total questions | 120 (100 scored, 20 unscored pretest) |
| Time allowed | 2 hours |
| Initial exam fee | $350 member / $450 non-member |
| Re-exam fee | $75 for eligible re-exams |
| Credential validity | Two years |
| Renewal CEUs | 40 CCB CEUs, at least 20 live |
Fees listed are the October 2026 initial-exam prices; HCCA/SCCE has announced higher rates effective January 1, 2027, so check the official fee page if you are planning a date near the transition. A full breakdown is in CHRC Certification Cost 2026. Eligibility generally requires one year in a full-time compliance position or 1,500 hours of direct compliance duties in the two years before applying, plus 20 CCB-approved CEUs in the prior 12 months with at least 10 live; see CHRC Requirements 2026 for the details and the accredited-university pathway.
Sequencing the Domains in Your Study Plan
Rather than a generic schedule, tie your order to the blueprint. The sequence below follows the logical flow of a compliance program and front-loads the heaviest domains. For a broader plan, see the CHRC Study Guide 2026.
Foundations: Domains 1 and 2 (32%)
- Map each agency (FDA, USDA, ORI, OCR, OHRP) to what it oversees
- Outline how a research compliance program is structured and governed
The heavy hitters: Domains 4 and 5 (38%)
- Practice audience-specific training scenarios
- Drill monitoring versus auditing versus investigating, plus billing and coverage analysis
Response chain: Domains 7, 3, and 6 (30%)
- Walk an allegation from intake through corrective action
- Review screening, discipline, and incentive principles
Integration
- Take timed mixed sets to build pacing across 120 questions in two hours
- Revisit weak domains using the weights as a guide
The reasoning: Domains 1 and 2 give you the vocabulary everything else depends on, Domains 4 and 5 carry the most points, and Domains 7, 3, and 6 reward you once you understand the earlier material. To gauge difficulty honestly, read How Hard Is the CHRC Exam?, and use realistic practice questions to find which domains need more time.
Key Takeaway
Let the published weights set your hours, but study the domains as one connected program: policies (Domain 1) define the standard, monitoring (Domain 5) detects gaps, and investigations (Domain 7) fix them.
Frequently Asked Questions
The Detailed Content Outline lists seven domains, from Standards, Policies, and Procedures through Investigations and Remedial Measures. Their weights sum to 100% of the scored questions.
Monitoring, Auditing, and Internal Reporting Systems carries the most weight at 20%, followed by Communication, Education, and Training at 18% and Standards, Policies, and Procedures at 17%.
No. Only 100 are scored. The other 20 are unidentified pretest questions, so you should answer every question with equal care.
HCCA states that no official study guide is available. Candidates use the Detailed Content Outline, the public sample questions, and the candidate-only 50-question practice exam, along with independent study aids.
A pass rate has not been publicly disclosed in the official materials located. The CHRC Pass Rate 2026 article explains what the available evidence does and does not show.