Certified Research Administrator (CRA) Exam — Questions and Answers

Question 1: A 'nonexclusive license' in technology transfer agreements means the licensor:

Can license the same technology to multiple parties simultaneously (Correct answer)
Grants the licensee the right to sublicense without restriction
Transfers full ownership of the patent to the licensee
Restricts the technology to a single commercial partner

Correct answer: Can license the same technology to multiple parties simultaneously

A nonexclusive license allows the licensor (e.g., university) to grant the same rights to multiple licensees at the same time, whereas an exclusive license restricts those rights to one party.

Question 2: During a QA walkthrough of the purchasing process, an auditor notes that the same employee approves purchase orders and reconciles the P-card statement. This represents which type of control weakness?

Collusion risk acceptance
Segregation of duties failure (Correct answer)
Compensating control deficiency
Authorization limit violation

Correct answer: Segregation of duties failure

Segregation of duties requires that incompatible functions—such as authorization and reconciliation—be performed by different individuals.

Question 3: Which quality assurance method is most commonly applied in professional standards & ethics to verify that CRA professional standards are being met?

Structured audits, peer reviews, and performance metrics aligned with industry benchmarks (Correct answer)
Annual reviews conducted exclusively by non-technical management
Informal self-assessment without external validation
Relying on client satisfaction surveys as the sole measure of quality

Correct answer: Structured audits, peer reviews, and performance metrics aligned with industry benchmarks

Structured audits, peer reviews, and performance metrics aligned with industry benchmarks are the most effective quality assurance methods in professional standards & ethics, providing objective, measurable evidence that CRA standards are consistently met.

Question 4: How does risk management apply to daily practice in Staff Management & Training for Certified Research Administrator professionals?

Through proactive identification of potential hazards and implementation of preventive measures (Correct answer)
Through annual safety audits exclusively
Only through responding to incidents after they occur
By avoiding high-risk situations entirely

Correct answer: Through proactive identification of potential hazards and implementation of preventive measures

Effective risk management in Staff Management & Training requires proactive hazard identification and preventive measures, not just reactive responses. This approach reduces incidents, improves outcomes, and protects both professionals and clients.

Question 5: Under 2 CFR 200, which of the following is a characteristic of an allowable cost?

It must be incurred solely for the benefit of the federal award
It must be allocable, reasonable, consistent with institutional policies, and conform to award terms (Correct answer)
It must be approved in writing by the program officer before being incurred
It must appear as a line item in the original approved budget

Correct answer: It must be allocable, reasonable, consistent with institutional policies, and conform to award terms

Uniform Guidance establishes that allowable costs must be necessary, reasonable, allocable, consistent with institutional policies, and conform to applicable award terms.

Question 6: Which practice best exemplifies the principle of 'assent' in pediatric research?

Allowing children over age 12 to sign the adult consent form independently
Having the school principal co-sign the consent document as a child advocate
Explaining the study to a child in age-appropriate language and seeking their affirmative agreement to participate (Correct answer)
Obtaining a parent's written permission and treating it as equivalent to child consent

Correct answer: Explaining the study to a child in age-appropriate language and seeking their affirmative agreement to participate

Assent requires that children be given developmentally appropriate information about the study and have their agreement solicited, separate from parental permission.

Question 7: Which technology trend is most likely to impact communication & stakeholder management in the CRA field in coming years?

Return to exclusively paper-based systems
Digital tools for enhanced data collection, analysis, and reporting (Correct answer)
Complete elimination of human professionals
Reduction in the need for professional certification

Correct answer: Digital tools for enhanced data collection, analysis, and reporting

Digital tools for enhanced data collection, analysis, and reporting represent the most significant and practical technology trend impacting communication & stakeholder management, augmenting rather than replacing professional expertise.

Question 8: What federal regulation governs research involving prisoners as human subjects and imposes heightened protections?

45 CFR Part 46 Subpart C (Correct answer)
21 CFR Part 50 Subpart B
42 CFR Part 93
45 CFR Part 46 Subpart A (Common Rule)

Correct answer: 45 CFR Part 46 Subpart C

45 CFR Part 46 Subpart C provides additional protections for prisoners involved in research, limiting permissible research categories.

Question 9: Which technology trend is most likely to impact professional standards & ethics in the CRA field in coming years?

Reduction in the need for professional certification
Return to exclusively paper-based systems
Complete elimination of human professionals
Digital tools for enhanced data collection, analysis, and reporting (Correct answer)

Correct answer: Digital tools for enhanced data collection, analysis, and reporting

Digital tools for enhanced data collection, analysis, and reporting represent the most significant and practical technology trend impacting professional standards & ethics, augmenting rather than replacing professional expertise.

Question 10: Which standard governs the design and construction of laboratory ventilation systems to protect researcher health and safety?

ANSI/AIHA Z9.5 (Correct answer)
29 CFR 1910.94
ASHRAE 62.1
NFPA 101

Correct answer: ANSI/AIHA Z9.5

ANSI/AIHA Z9.5 is the Laboratory Ventilation standard that establishes minimum requirements for lab exhaust and supply air systems.

Question 11: During a routine FDA inspection, inspectors request all drug accountability records for the past three years. The minimum retention period for such records under 21 CFR Part 312 after study completion is:

10 years
5 years
2 years (Correct answer)
1 year

Correct answer: 2 years

Under 21 CFR 312.62(c), drug disposition records must be retained for 2 years after marketing approval or 2 years after the IND is discontinued.

Question 12: Which approach best supports a 'culture of compliance' in research administration?

Restricting QA activities to the sponsored programs office only
Relying solely on post-award audits to identify problems
Avoiding disclosure of findings to prevent reputational damage
Integrating compliance training, transparent reporting channels, and leadership accountability into daily operations (Correct answer)

Correct answer: Integrating compliance training, transparent reporting channels, and leadership accountability into daily operations

A compliance culture requires ongoing education, open communication, and visible commitment from leadership across all levels of the organization.

Question 13: Under OMB Uniform Guidance, what is the threshold for equipment requiring special tracking and management procedures?

$1,000
$2,500
$5,000 (Correct answer)
$10,000

Correct answer: $5,000

Under 2 CFR 200.1, equipment is defined as tangible personal property with a useful life of more than one year and a per-unit acquisition cost of $5,000 or more.

Question 14: Under the Common Rule (45 CFR 46), which condition must be met for an IRB to waive the requirement for written informed consent documentation?

The study is conducted at a single site with fewer than 50 participants
The PI holds a federal research grant exceeding $500,000
All subjects are adults with full decision-making capacity
The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights (Correct answer)

Correct answer: The research involves no more than minimal risk and the waiver will not adversely affect subjects' rights

45 CFR 46.117(c) allows IRBs to waive written consent documentation when the research presents no more than minimal risk and the waiver won't adversely affect participants' rights and welfare.

Question 15: Which standard of practice is MOST important for ensuring quality in Facility Operations & Maintenance?

Minimizing documentation to focus on practical work
Strictly adhering to the same procedure in every situation
Following evidence-based protocols while adapting to specific circumstances (Correct answer)
Using the most advanced technology available regardless of need

Correct answer: Following evidence-based protocols while adapting to specific circumstances

Evidence-based protocols provide a foundation of proven practices, but effective Certified Research Administrator professionals must also adapt their approach based on specific circumstances and individual case needs within Facility Operations & Maintenance.

Question 16: Which federal regulation requires research institutions to maintain records of hazardous waste disposal for a minimum of three years?

NIH Guidelines Section IV-B
EPA 40 CFR Part 262 (Correct answer)
OSHA 29 CFR 1910.1200
NSF Facilities Policy 2.4

Correct answer: EPA 40 CFR Part 262

EPA 40 CFR Part 262 governs hazardous waste generators and mandates retention of waste manifests and disposal records for at least three years.

Question 17: Which of the following is an example of a 'direct cost' on a sponsored research project?

Salary of a postdoctoral researcher working 100% on the specific project (Correct answer)
Library subscriptions used by the entire university
Utilities for the university's central administration building
Human resources department costs for processing payroll

Correct answer: Salary of a postdoctoral researcher working 100% on the specific project

Direct costs are costs that can be specifically identified with a particular sponsored project, such as salaries of personnel working solely on that project.

Question 18: What does informed consent mean?

Participants are forced
Researchers decide
Participants waive all rights
Participants understand and voluntarily agree (Correct answer)

Correct answer: Participants understand and voluntarily agree

Informed consent is a fundamental ethical principle in research, meaning that potential participants must be fully informed about the study's purpose, procedures, risks, and benefits before they agree to participate. Their agreement must be voluntary, free from coercion, and based on a clear understanding of what their involvement entails, ensuring respect for autonomy.

Question 19: When a conflict arises between standard procedures and a unique situation in Quality Assurance Programs, what should a CRA professional prioritize?

Safety and ethical obligations while seeking expert consultation (Correct answer)
Strict adherence to written procedures without exception
The preference of the client or stakeholder
The most cost-effective solution available

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Quality Assurance Programs. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 20: A Material Transfer Agreement (MTA) is used to govern the transfer of:

Personnel between collaborating research institutions
Intellectual property rights in a licensing arrangement
Tangible research materials between institutions or companies (Correct answer)
Financial funds between sponsored research accounts

Correct answer: Tangible research materials between institutions or companies

An MTA is a contract that defines the terms and conditions under which tangible biological or chemical materials (e.g., cell lines, compounds, reagents) are shared between organizations.

Question 21: Under the Fair Labor Standards Act (FLSA), which classification most commonly applies to sponsored research staff performing professional grant management duties?

Exempt administrative employees (Correct answer)
Exempt executive employees
Temporary seasonal workers
Non-exempt hourly employees

Correct answer: Exempt administrative employees

Grant management professionals typically meet the FLSA administrative exemption criteria because their primary duty involves office work directly related to management or general business operations.

Question 22: When is it appropriate to request a no-cost extension on a federal research award?

When additional funds are needed to complete the project
When the PI wants to extend the project for convenience
When the institution needs more time to submit financial reports
When the scope of work cannot be completed within the project period due to unforeseen circumstances (Correct answer)

Correct answer: When the scope of work cannot be completed within the project period due to unforeseen circumstances

No-cost extensions are justified only when additional time—not funds—is needed due to unforeseen delays in completing the approved scope of work.

Question 23: A cost is considered 'reasonable' under Uniform Guidance if:

It has been approved by the institutional CFO
It does not exceed $10,000 per transaction
It has been competitively bid with at least three quotes
It reflects what a prudent person would pay for similar goods or services under similar circumstances (Correct answer)

Correct answer: It reflects what a prudent person would pay for similar goods or services under similar circumstances

The 'reasonable' standard applies the 'prudent person' test — whether the cost would be recognized as ordinary and necessary by a sound business decision-maker.

Question 24: A participant in a federally funded study experiences a serious adverse event. Which entity has oversight authority to investigate whether human subject protections were violated?

The Office for Human Research Protections (OHRP) (Correct answer)
The National Science Foundation (NSF)
The Department of Justice (DOJ)
The Centers for Medicare and Medicaid Services (CMS)

Correct answer: The Office for Human Research Protections (OHRP)

OHRP has authority under 45 CFR 46 to investigate compliance with human subject protection regulations at institutions receiving HHS funding.

Question 25: A CRA discovers that a subrecipient has consistently failed to submit required financial reports on time. Under 2 CFR 200, what is the most appropriate corrective action?

Waive the reporting requirement for the remainder of the award
Terminate the subaward immediately without notice
Transfer the subrecipient's funds to a different organization
Issue a high-risk designation and increase monitoring intensity (Correct answer)

Correct answer: Issue a high-risk designation and increase monitoring intensity

2 CFR 200.332 allows pass-through entities to impose additional conditions on high-risk subrecipients, including enhanced monitoring.

Question 26: What does the concept of 'therapeutic misconception' mean in the context of research subject protections?

IRBs conflate standard-of-care treatment with experimental intervention
Sponsors assume all adverse events are unrelated to the study drug
Investigators believe all research will ultimately benefit participants
Subjects mistakenly believe research procedures are designed for their individual benefit rather than to generate generalizable knowledge (Correct answer)

Correct answer: Subjects mistakenly believe research procedures are designed for their individual benefit rather than to generate generalizable knowledge

Therapeutic misconception occurs when subjects fail to distinguish research from individualized clinical care, undermining true informed consent.

Question 27: Which documentation practice is most important for communication & stakeholder management in the CRA field?

Maintaining complete, accurate, and timely records (Correct answer)
Using informal notes instead of official records
Recording only successful outcomes
Documenting only when legally required

Correct answer: Maintaining complete, accurate, and timely records

Maintaining complete, accurate, and timely records is crucial for accountability, quality assurance, and legal compliance in communication & stakeholder management.

Question 28: In Medication Management Oversight, what is the FIRST step a CRA professional should take when encountering a new case or situation?

Consult with a supervisor before taking any action
Conduct a comprehensive assessment and gather all relevant information (Correct answer)
Document the situation and wait for further instructions
Implement an immediate solution based on past experience

Correct answer: Conduct a comprehensive assessment and gather all relevant information

In Medication Management Oversight, a thorough initial assessment ensures all relevant factors are identified before deciding on an appropriate course of action. This systematic approach is fundamental to Certified Research Administrator practice.

Question 29: A research facility manager discovers that a fume hood's face velocity has dropped below 100 fpm. The FIRST action should be to:

Notify all building occupants via email
Document the finding in the next annual safety report
Remove the fume hood from service and restrict access (Correct answer)
Request a capital budget increase for a replacement

Correct answer: Remove the fume hood from service and restrict access

A fume hood with inadequate face velocity poses an immediate inhalation hazard; it must be taken out of service until repaired and re-certified.

Question 30: Why is intellectual property (IP) addressed in contracts?

To define ownership of research outcomes (Correct answer)
To remove responsibilities
To avoid copyright issues
To confuse collaborators

Correct answer: To define ownership of research outcomes

Intellectual property (IP) clauses are crucial in research contracts to clearly define who owns the rights to any inventions, discoveries, or data generated during the project. This prevents future disputes over ownership, commercialization, and publication rights. Establishing IP ownership upfront ensures that all parties understand their rights and obligations regarding the research outcomes.

Question 31: Which quality improvement method is most applicable to quality assurance & continuous improvement in Certified Research Administrator?

Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)
Ignoring feedback and maintaining status quo
Making changes only when mandated by regulators
Implementing changes without measuring outcomes

Correct answer: Plan-Do-Check-Act (PDCA) continuous improvement cycle

The PDCA cycle is widely recognized as the most effective quality improvement method, allowing CRA professionals to systematically improve quality assurance & continuous improvement practices.

Question 32: Which type of program announcement indicates that NIH will accept applications at any time during a specified period with no fixed deadline?

Request for Proposals (RFP)
Parent Announcement
Request for Applications (RFA)
Program Announcement (PA) (Correct answer)

Correct answer: Program Announcement (PA)

Program Announcements (PAs) describe standing NIH interests with standard submission dates, while RFAs have a single receipt date and set-aside funds.

Question 33: Under the Cost Accounting Standards (CAS), which standard specifically addresses the composition of the cost of money as an element of the cost of capital assets?

CAS 403
CAS 414 (Correct answer)
CAS 420
CAS 401

Correct answer: CAS 414

CAS 414 addresses the cost of money as an element of the cost of capital assets under construction, affecting how facilities costs are allocated on federal contracts.

Question 34: The 'first-to-file' patent system adopted by the U.S. under the America Invents Act (AIA) of 2011 means that:

Foreign inventors are given priority over domestic filers
Universities must always file before industry sponsors in collaborative research
The first applicant to file a patent application is generally entitled to the patent (Correct answer)
The inventor who first conceived the invention receives the patent regardless of when they file

Correct answer: The first applicant to file a patent application is generally entitled to the patent

The AIA shifted the U.S. from a first-to-invent system to a first-inventor-to-file system, making timely patent filing critically important in technology transfer to establish priority.

Question 35: In a modular NIH grant budget, what is the maximum allowable amount per module?

$100,000
$50,000
$25,000 (Correct answer)
$10,000

Correct answer: $25,000

NIH modular budgets are structured in modules of $25,000 each, up to a maximum of $250,000 direct costs per year for qualifying mechanisms.

Question 36: A principal investigator requests to move $15,000 from personnel to equipment mid-project. Under Uniform Guidance, when is prior approval from the federal agency required for this rebudgeting?

Prior approval is never required if the PI approves
When the reallocation exceeds 25% of the total award
Prior approval is always required for any personnel-to-equipment transfer
When the reallocation exceeds 10% of the total award (Correct answer)

Correct answer: When the reallocation exceeds 10% of the total award

Under 2 CFR 200.308, prior agency approval is required when rebudgeting between direct cost categories exceeds 10% of the total award amount.

Question 37: Which of the following is a fundamental principle of regulatory compliance & legal framework as it applies to Certified Retail Analyst?

Prioritizing speed of completion over accuracy and compliance
Avoiding documentation to streamline workflow efficiency
Relying solely on personal experience without reference to guidelines
Systematic evaluation and adherence to established industry standards (Correct answer)

Correct answer: Systematic evaluation and adherence to established industry standards

A fundamental principle of regulatory compliance & legal framework in Certified Retail Analyst is the systematic evaluation and adherence to established industry standards, which ensures consistency, quality, and regulatory compliance across all professional activities.

Question 38: What does 'assurance' refer to in the context of human subjects research compliance at a federally funded institution?

A financial guarantee provided to grant sponsors
A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46 (Correct answer)
An IRB approval letter for a specific protocol
A certification that all researchers completed CITI training

Correct answer: A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46

A Federalwide Assurance is a formal institutional commitment to OHRP to follow federal human subjects protections for all research.

Question 39: What documentation practice is considered essential in Medication Management Oversight within the Certified Research Administrator field?

Recording actions, observations, and outcomes in real-time or as close to the event as possible (Correct answer)
Completing all documentation at the end of the workday
Only documenting unusual events or complications
Using shorthand notes that can be expanded later if needed

Correct answer: Recording actions, observations, and outcomes in real-time or as close to the event as possible

Real-time or near-real-time documentation in Medication Management Oversight ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 40: A research contract specifies deliverables using the term 'best efforts.' This language most directly affects which aspect of contract performance?

The contractor's cost allowability standards
The government's audit rights
The contractor's IP ownership rights
The contractor's liability for failure to achieve specific outcomes (Correct answer)

Correct answer: The contractor's liability for failure to achieve specific outcomes

'Best efforts' language limits contractor liability to making reasonable attempts rather than guaranteeing specific research results.

Question 41: Which of the following costs is typically unallowable under federal grants per 2 CFR 200?

Alcoholic beverages purchased for a faculty recruitment dinner (Correct answer)
Salaries for research staff directly working on the project
Travel costs to present research findings at a conference
Indirect costs calculated at the negotiated F&A rate

Correct answer: Alcoholic beverages purchased for a faculty recruitment dinner

2 CFR 200.423 explicitly lists alcoholic beverages as an unallowable cost under federal awards.

Question 42: In a multi-site clinical trial, Site B relies on Site A's IRB as the IRB of record. If the study is suspended at Site A due to safety concerns, what must Site B do?

Notify only their institutional official within 30 days
Continue the study while notifying their local IRB of the suspension
Immediately suspend enrollment and await guidance from the reviewing IRB (Correct answer)
Conduct an independent risk-benefit analysis before suspending

Correct answer: Immediately suspend enrollment and await guidance from the reviewing IRB

When the IRB of record suspends a study, all relying sites must follow the same suspension because they operate under that IRB's authority.

Question 43: Which type of IRB review is appropriate for research involving no more than minimal risk that uses educational tests or survey procedures?

Continuing review waiver
Exempt determination (Correct answer)
Full board review
Expedited review

Correct answer: Exempt determination

Category 2 of the exempt categories covers research involving educational tests, surveys, or interviews that present no more than minimal risk under certain conditions.

Question 44: What is 'program income' in the context of federal grants?

Revenue from technology transfer unrelated to a specific award
Interest earned on federal funds held in the institutional bank account
Gross income earned by the grantee that is directly generated by or earned as a result of the federal award (Correct answer)
Funds generated by the institution's endowment to support research

Correct answer: Gross income earned by the grantee that is directly generated by or earned as a result of the federal award

Program income is gross income directly generated by or earned as a result of activities supported by a federal award during the project period.

Question 45: Under FAR 52.227-11, what must a contractor do when electing to retain title to a subject invention made under a federal contract?

License the invention to the government exclusively
File a patent application within 24 months of disclosure
File a patent application within 12 months of disclosure (Correct answer)
Disclose the invention to the agency within 2 years

Correct answer: File a patent application within 12 months of disclosure

FAR 52.227-11 (Patent Rights – Ownership by Contractor) requires a patent application to be filed within 12 months of the invention disclosure.

Question 46: A Phase III oncology trial uses a placebo controlled design. The placebo must be:

An approved saline injection regardless of active drug route
Any commercially available inactive tablet available at the pharmacy
Manufactured and labeled to be indistinguishable from the active drug in appearance and packaging (Correct answer)
Prepared by the site pharmacy without sponsor oversight

Correct answer: Manufactured and labeled to be indistinguishable from the active drug in appearance and packaging

Placebos must be manufactured and labeled to match the active drug's appearance and packaging to maintain blinding integrity.

Question 47: How does continuing education relate to communication & stakeholder management for CRA certified professionals?

It is optional and rarely impacts practice quality
It ensures professionals stay current with evolving standards and best practices (Correct answer)
It is required only for entry-level practitioners
It is only needed when changing employers

Correct answer: It ensures professionals stay current with evolving standards and best practices

Continuing education ensures CRA professionals stay current with evolving standards, technologies, and best practices in communication & stakeholder management, maintaining competency throughout their careers.

Question 48: Which of the following best describes the role of a corrective action plan (CAP) following a QA finding?

To outline specific steps, responsible parties, and timelines to remediate identified deficiencies (Correct answer)
To document that the finding was not the institution's fault
To transfer the finding to a different departmental unit for resolution
To request a waiver from the sponsoring agency for the violation

Correct answer: To outline specific steps, responsible parties, and timelines to remediate identified deficiencies

A CAP provides a structured roadmap with accountability measures to ensure identified QA deficiencies are resolved systematically.

Question 49: Under DOD grant regulations (2 CFR 1108), what is required before a researcher may publish research results from a DOD-funded contract?

Submission of all manuscripts to the Federal Register
Immediate publication is encouraged with no restrictions
Prior written approval from the contracting officer for every paper
A prepublication security review period allowing DOD to review for classified or controlled information (Correct answer)

Correct answer: A prepublication security review period allowing DOD to review for classified or controlled information

DOD contracts typically include a prepublication review clause giving the agency a window (often 30-90 days) to review manuscripts for security concerns.

Question 50: Why include a timeline in the proposal?

It helps demonstrate project feasibility (Correct answer)
It avoids ethical review
It increases word count
It boosts the budget

Correct answer: It helps demonstrate project feasibility

Including a detailed timeline in a research proposal demonstrates the project's feasibility and shows reviewers that the researcher has a realistic plan for completing the work within the proposed timeframe. It breaks down the project into manageable phases, assigning specific durations to each task. This provides confidence that the project can be successfully executed and managed.

Question 51: Which of the following is considered a direct cost on a sponsored research project?

The provost's salary
General accounting department salaries
A graduate research assistant's stipend on the project (Correct answer)
Heat and electricity for the research building

Correct answer: A graduate research assistant's stipend on the project

A graduate research assistant whose effort is specifically dedicated to the sponsored project is a direct cost, identifiable with the particular project.

Question 52: A deferred maintenance backlog refers to:

Maintenance work completed ahead of schedule
Routine preventive maintenance logged in a CMMS
Maintenance work postponed due to budget or resource constraints (Correct answer)
Emergency repairs performed without prior authorization

Correct answer: Maintenance work postponed due to budget or resource constraints

Deferred maintenance is work that was not performed when due or planned and has been postponed, often creating increasing repair costs over time.

Question 53: What is the purpose of a concept paper or white paper submitted to a federal agency before a formal solicitation is issued?

To substitute for a full proposal submission
To gauge agency interest and feedback before investing in a full proposal (Correct answer)
To establish intellectual property rights early
To register the institution in SAM.gov

Correct answer: To gauge agency interest and feedback before investing in a full proposal

Concept papers allow applicants to receive informal feedback on alignment with agency priorities before committing resources to a full proposal.

Question 54: Which of the following is a fundamental principle of quality assurance & continuous improvement as it applies to Certified Retail Analyst?

Systematic evaluation and adherence to established industry standards (Correct answer)
Avoiding documentation to streamline workflow efficiency
Prioritizing speed of completion over accuracy and compliance
Relying solely on personal experience without reference to guidelines

Correct answer: Systematic evaluation and adherence to established industry standards

A fundamental principle of quality assurance & continuous improvement in Certified Retail Analyst is the systematic evaluation and adherence to established industry standards, which ensures consistency, quality, and regulatory compliance across all professional activities.

Question 55: When developing a project budget for a federal grant, which cost category typically requires the most detailed justification?

Personnel and fringe benefits (Correct answer)
Indirect costs
Supplies
Travel costs

Correct answer: Personnel and fringe benefits

Personnel and fringe benefits are usually the largest budget item and require detailed justification including effort percentages and salary bases.

Question 56: Which quality assurance method is most commonly applied in regulatory compliance & legal framework to verify that CRA professional standards are being met?

Informal self-assessment without external validation
Structured audits, peer reviews, and performance metrics aligned with industry benchmarks (Correct answer)
Relying on client satisfaction surveys as the sole measure of quality
Annual reviews conducted exclusively by non-technical management

Correct answer: Structured audits, peer reviews, and performance metrics aligned with industry benchmarks

Structured audits, peer reviews, and performance metrics aligned with industry benchmarks are the most effective quality assurance methods in regulatory compliance & legal framework, providing objective, measurable evidence that CRA standards are consistently met.

Question 57: What is the ethical significance of including a placebo arm in a randomized controlled trial involving seriously ill patients?

It satisfies the principle of beneficence by creating equal groups
It guarantees equal therapeutic benefit to all enrolled subjects
It eliminates the need for a DSMB because blinding controls for bias
It raises the ethical concern of withholding potentially beneficial treatment from the control group (Correct answer)

Correct answer: It raises the ethical concern of withholding potentially beneficial treatment from the control group

The Declaration of Helsinki requires that placebo use be justified only when no proven intervention exists, due to concerns about withholding effective treatment.

Question 58: Which type of training is MOST appropriate for teaching staff how to navigate the institution's grants management system?

Classroom lecture with slides only
Hands-on simulation or sandbox environment training (Correct answer)
Reading the system user manual independently
Shadowing a colleague without guided practice

Correct answer: Hands-on simulation or sandbox environment training

Hands-on simulation in a sandbox environment allows staff to practice system navigation without risk to live data, accelerating competency.

Question 59: A PI proposes to use existing patient data collected for clinical care purposes in a new research study. The first question the research administrator should ask is:

Does this research require IRB review and approval? (Correct answer)
Will the data be de-identified?
What is the estimated budget for data management?
How many patients are in the dataset?

Correct answer: Does this research require IRB review and approval?

Any research involving human subjects data requires IRB determination—whether full review, expedited, or exempt—before the project can begin.

Question 60: A university receives a federal grant for research on a dual-use research of concern (DURC) pathogen. What additional oversight is required?

OSHA Biosafety Committee approval only
DOD Special Access Program clearance
FDA Investigational New Drug exemption
Institutional Review Entity (IRE) review and an Institutional Biosafety Committee assessment (Correct answer)

Correct answer: Institutional Review Entity (IRE) review and an Institutional Biosafety Committee assessment

DURC policy requires institutions to establish an Institutional Review Entity and conduct biosafety risk assessments for covered research.

Question 61: A CRA professional encounters an unfamiliar situation while performing regulatory compliance & legal framework duties. What is the most appropriate first action?

Apply a solution from an unrelated field without verification
Skip the task entirely and move to the next assignment
Consult relevant standards, guidelines, or a qualified supervisor before proceeding (Correct answer)
Proceed based on general assumptions to avoid delays

Correct answer: Consult relevant standards, guidelines, or a qualified supervisor before proceeding

When facing unfamiliar situations in regulatory compliance & legal framework, the most appropriate action is to consult relevant standards, guidelines, or a qualified supervisor. This ensures safety, accuracy, and compliance while building professional knowledge.

Question 62: What triggers the requirement for a Data Use Agreement (DUA) under HIPAA for research purposes?

Publishing research involving de-identified patient records
Collecting survey data from hospital employees
Receiving a limited data set containing protected health information from a covered entity (Correct answer)
Using any patient data in research

Correct answer: Receiving a limited data set containing protected health information from a covered entity

HIPAA requires a DUA when a covered entity provides a limited data set (with some PHI removed but not fully de-identified) for research.

Question 63: Under 2 CFR 200.430, salaries of employees working on federal awards must be supported by which type of documentation?

Annual performance reviews
A records system that reflects actual activity for all employees whose salaries are charged to federal awards (Correct answer)
Supervisor attestation letters submitted quarterly
Monthly budget variance reports

Correct answer: A records system that reflects actual activity for all employees whose salaries are charged to federal awards

2 CFR 200.430 requires a records system that accurately reflects the actual activity of employees whose compensation is charged to federal awards.

Question 64: A CRA reviewing site records finds a subject received a higher dose than the protocol specified due to a dispensing error. Under GCP, this constitutes a:

Protocol deviation that must be reported to the IRB and sponsor (Correct answer)
Minor protocol deviation requiring local documentation only
Adverse event that can be captured at the next monitoring visit
Good documentation practice failure only

Correct answer: Protocol deviation that must be reported to the IRB and sponsor

A dosing error that deviates from the approved protocol must be reported promptly to both the sponsor and IRB per GCP requirements.

Question 65: A QA review reveals that a PI charged meals for a working lunch to a federal grant without documentation of the business purpose. Which cost principle is implicated?

Reasonableness under 2 CFR 200.404
Consistency under 2 CFR 200.405
Allocability under 2 CFR 200.405
Allowability and documentation under 2 CFR 200.403 (Correct answer)

Correct answer: Allowability and documentation under 2 CFR 200.403

2 CFR 200.403 requires that costs be adequately documented; without a business purpose, the charge fails the allowability test.

Question 66: A Cooperative Research and Development Agreement (CRADA) differs from a standard federal grant primarily because:

CRADAs provide direct funding to the non-federal partner
CRADAs are governed exclusively by 2 CFR 200
CRADAs require congressional authorization for each agreement
CRADAs allow a federal laboratory to collaborate with a private partner and share IP rights (Correct answer)

Correct answer: CRADAs allow a federal laboratory to collaborate with a private partner and share IP rights

A CRADA enables a federal lab to work with a non-federal entity, sharing resources and IP rights—distinct from grants where only funding flows to the recipient.

Question 67: What documentation practice is considered essential in Financial Management & Budgeting within the Certified Research Administrator field?

Only documenting unusual events or complications
Using shorthand notes that can be expanded later if needed
Recording actions, observations, and outcomes in real-time or as close to the event as possible (Correct answer)
Completing all documentation at the end of the workday

Correct answer: Recording actions, observations, and outcomes in real-time or as close to the event as possible

Real-time or near-real-time documentation in Financial Management & Budgeting ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 68: Which clause defines payment terms?

Payment schedule clause (Correct answer)
Dispute resolution clause
Abstract clause
IP clause

Correct answer: Payment schedule clause

The payment schedule clause within a research contract explicitly outlines the terms for financial transactions, including the amount, frequency, and conditions under which payments will be made. This clause ensures clarity regarding invoicing, payment milestones, and due dates. It is essential for managing the financial flow of the project and ensuring timely compensation for services or deliverables.

Question 69: A research institution's negotiated F&A rate is 52% MTDC. If a project has $200,000 in salaries and $30,000 in equipment, what is the F&A cost?

$104,000
$104,000 (Correct answer)
$104,000 minus equipment exclusion
$119,600

Correct answer: $104,000

MTDC excludes equipment, so F&A is calculated on $200,000 only: $200,000 × 52% = $104,000.

Question 70: A foreign national researcher joins a federally funded project involving export-controlled technology. What must the research administrator assess first?

The researcher's visa expiration date
Whether a deemed export license is required (Correct answer)
The researcher's publication history
Whether the researcher holds dual citizenship

Correct answer: Whether a deemed export license is required

Sharing export-controlled technology with a foreign national in the U.S. is a 'deemed export' and may require an EAR or ITAR license.

Question 71: What is the PRIMARY purpose of continuing education requirements in Regulatory Compliance & Licensing for CRA professionals?

Earning additional credentials for career advancement
Fulfilling mandatory regulatory requirements only
Networking with other professionals in the field
Maintaining current knowledge and competency as the field evolves (Correct answer)

Correct answer: Maintaining current knowledge and competency as the field evolves

Continuing education in Regulatory Compliance & Licensing ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Certified Research Administrator field.

Question 72: What is the primary ethical obligation of a CRA professional when a conflict of interest arises during professional standards & ethics activities?

Ignore the conflict if it does not directly affect the current task
Disclose the conflict to all relevant parties and recuse from the decision if necessary (Correct answer)
Resolve the conflict privately without informing stakeholders
Proceed while favoring the outcome that benefits the professional personally

Correct answer: Disclose the conflict to all relevant parties and recuse from the decision if necessary

The primary ethical obligation when a conflict of interest arises in professional standards & ethics is to disclose it to all relevant parties and, if necessary, recuse from the decision. This maintains professional integrity and stakeholder trust.

Question 73: When a research institution must dispose of radioactive waste, which federal agency's regulations primarily govern this process?

Occupational Safety and Health Administration (OSHA)
Department of Energy (DOE)
Nuclear Regulatory Commission (NRC) (Correct answer)
Environmental Protection Agency (EPA)

Correct answer: Nuclear Regulatory Commission (NRC)

The NRC regulates the possession, use, and disposal of radioactive materials at licensed research institutions under 10 CFR Parts 20 and 35.

Question 74: When must an institution obtain prior approval before incurring pre-award costs on a federal grant?

Always; all pre-award costs require written sponsor approval
When required by the terms of the award or the federal agency's regulations (Correct answer)
Only when the costs exceed $25,000
Never; pre-award costs are always the institution's financial risk

Correct answer: When required by the terms of the award or the federal agency's regulations

Pre-award costs may be incurred up to 90 days before the award when the non-federal entity accepts full financial responsibility, but some agencies require prior approval per their specific terms.

Question 75: In Certified Research Administrator, what role does communication & stakeholder management play in ensuring client/stakeholder satisfaction?

It replaces the need for direct communication
It builds trust through demonstrated competence and consistency (Correct answer)
It has no direct impact on stakeholder satisfaction
It only matters during initial certification

Correct answer: It builds trust through demonstrated competence and consistency

Communication & Stakeholder Management builds trust through demonstrated competence and consistency, which directly contributes to stakeholder satisfaction and confidence in the CRA professional.

Question 76: What does a confidentiality clause do?

Publishes data automatically
Lists internal phone numbers
Allows open sharing
Protects sensitive information (Correct answer)

Correct answer: Protects sensitive information

A confidentiality clause in a research contract legally obligates the parties to protect and not disclose sensitive or proprietary information shared during the course of the project. This can include research data, trade secrets, personal information, or unpatented discoveries. Its purpose is to safeguard valuable information and maintain trust between collaborators, preventing unauthorized dissemination.

Question 77: Which of the following best describes the purpose of an Institutional Biosafety Committee (IBC) under the NIH Guidelines?

To manage laboratory safety training programs
To issue OSHA compliance certifications for lab spaces
To review and oversee recombinant DNA and synthetic nucleic acid research for biosafety compliance (Correct answer)
To approve human subjects research involving biological samples

Correct answer: To review and oversee recombinant DNA and synthetic nucleic acid research for biosafety compliance

The IBC's primary role under NIH Guidelines is to review research involving recombinant or synthetic nucleic acid molecules for biosafety risk.

Question 78: How does risk management apply to daily practice in Medication Management Oversight for Certified Research Administrator professionals?

Only through responding to incidents after they occur
Through annual safety audits exclusively
By avoiding high-risk situations entirely
Through proactive identification of potential hazards and implementation of preventive measures (Correct answer)

Correct answer: Through proactive identification of potential hazards and implementation of preventive measures

Effective risk management in Medication Management Oversight requires proactive hazard identification and preventive measures, not just reactive responses. This approach reduces incidents, improves outcomes, and protects both professionals and clients.

Question 79: Which federal regulation governs the export of controlled biological agents and select agents for research purposes?

HIPAA Privacy Rule
EAR (Export Administration Regulations)
Select Agent Program (42 CFR Part 73) (Correct answer)
ITAR (International Traffic in Arms Regulations)

Correct answer: Select Agent Program (42 CFR Part 73)

The Select Agent Program under 42 CFR Part 73 regulates possession, use, and transfer of biological select agents and toxins.

Question 80: When a staff member requests a reasonable accommodation for a disability under the Americans with Disabilities Act (ADA), the research administrator supervisor should:

Ask the employee to provide a detailed medical history
Deny the request if it affects team productivity
Initiate the interactive process with HR and the employee to identify effective accommodations (Correct answer)
Determine unilaterally whether the accommodation is warranted

Correct answer: Initiate the interactive process with HR and the employee to identify effective accommodations

The ADA requires an interactive process involving the employer and employee to identify reasonable accommodations; supervisors must engage HR rather than act unilaterally.

Question 81: Which financial statement is used to report cumulative expenditures on a federal grant to the sponsoring agency?

SF-LLL
SF-270
SF-425 (Correct answer)
SF-424

Correct answer: SF-425

The SF-425 (Federal Financial Report) is the standard form used to report financial status, including cumulative expenditures, on federal awards.

Question 82: When a conflict arises between standard procedures and a unique situation in Financial Management & Budgeting, what should a CRA professional prioritize?

The preference of the client or stakeholder
Safety and ethical obligations while seeking expert consultation (Correct answer)
The most cost-effective solution available
Strict adherence to written procedures without exception

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Financial Management & Budgeting. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 83: Which regulatory body oversees the registration of controlled substances used in clinical research in the US?

Centers for Medicare & Medicaid Services
Office for Human Research Protections (OHRP)
Drug Enforcement Administration (DEA) (Correct answer)
FDA Center for Drug Evaluation and Research

Correct answer: Drug Enforcement Administration (DEA)

The DEA regulates registration, scheduling, handling, and record-keeping for controlled substances including those used in investigational studies.

Question 84: In Certified Research Administrator, what role does quality assurance & continuous improvement play in ensuring client/stakeholder satisfaction?

It has no direct impact on stakeholder satisfaction
It builds trust through demonstrated competence and consistency (Correct answer)
It only matters during initial certification
It replaces the need for direct communication

Correct answer: It builds trust through demonstrated competence and consistency

Quality Assurance & Continuous Improvement builds trust through demonstrated competence and consistency, which directly contributes to stakeholder satisfaction and confidence in the CRA professional.

Question 85: When onboarding a new grants coordinator, which resource should be provided FIRST to establish regulatory context?

The institution's indirect cost rate agreement
The department's internal budget templates
The Uniform Guidance (2 CFR 200) overview (Correct answer)
A list of active sponsored projects

Correct answer: The Uniform Guidance (2 CFR 200) overview

The Uniform Guidance is the foundational federal regulatory document governing grants management, making it the essential first context for new staff.

Question 86: A research administrator needs to address chronic absenteeism in a post-award team. What is the MOST appropriate first step?

Issue a written warning without prior discussion
Document attendance patterns and schedule a private discussion with the employee (Correct answer)
Immediately escalate to HR for disciplinary action
Redistribute the absent employee's workload permanently

Correct answer: Document attendance patterns and schedule a private discussion with the employee

Documenting patterns and holding a private conversation establishes facts and gives the employee an opportunity to explain before formal action is taken.

Question 87: The Bayh-Dole Act of 1980 primarily governs which aspect of federally funded research?

Export controls on dual-use research findings
Human subjects protections in clinical trials
Ownership and commercialization of inventions arising from federal funding (Correct answer)
Financial conflict of interest disclosure requirements

Correct answer: Ownership and commercialization of inventions arising from federal funding

Bayh-Dole allows universities and small businesses to retain title to inventions made with federal funding and encourages commercialization through technology transfer.

Question 88: What is the PRIMARY purpose of continuing education requirements in Financial Management & Budgeting for CRA professionals?

Networking with other professionals in the field
Fulfilling mandatory regulatory requirements only
Maintaining current knowledge and competency as the field evolves (Correct answer)
Earning additional credentials for career advancement

Correct answer: Maintaining current knowledge and competency as the field evolves

Continuing education in Financial Management & Budgeting ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Certified Research Administrator field.

Question 89: What does the term 'carryover' mean in the context of federal grant management?

Transferring personnel from one project to another
Carrying indirect costs forward to a new rate negotiation
Spending unobligated balances from one budget period in a subsequent budget period (Correct answer)
Rolling over unexpired subcontracts

Correct answer: Spending unobligated balances from one budget period in a subsequent budget period

Carryover refers to the authorized use of unobligated funds remaining at the end of one budget period in a subsequent budget period.

Question 90: Under Uniform Guidance 2 CFR 200, what is the threshold above which a non-Federal entity must have a single audit conducted?

$250,000 in federal expenditures
$500,000 in federal expenditures
$750,000 in federal expenditures (Correct answer)
$1,000,000 in federal expenditures

Correct answer: $750,000 in federal expenditures

2 CFR 200.501 requires a single audit for non-Federal entities that expend $750,000 or more in federal awards during a fiscal year.

Question 91: The process of recovering indirect costs from a federal sponsor based on an approved rate is known as:

F&A cost recovery (Correct answer)
Cost sharing
Budget reallocation
Carryover application

Correct answer: F&A cost recovery

Facilities and Administrative (F&A) cost recovery refers to the process of applying an approved indirect cost rate to allowable direct costs to recover overhead expenses.

Question 92: Under Bayh-Dole, a university that elects title to a federally funded invention must notify the sponsoring agency within how many months of the inventor's report?

6 months
12 months (Correct answer)
2 months
24 months

Correct answer: 12 months

Bayh-Dole regulations (37 CFR 401) require the contractor to elect title within two years of the inventor's report, but notification of the election intention to the agency must occur within the required timeframe set at 12 months of the invention report.

Question 93: What is cost sharing?

Institutional contribution to project costs (Correct answer)
Bonus fund for investigators
PI’s salary
A matching contribution by staff

Correct answer: Institutional contribution to project costs

Cost sharing, also known as matching, refers to the portion of project costs not borne by the sponsor but contributed by the institution or other third parties. This commitment demonstrates institutional investment in the research and can be required by sponsors to ensure shared responsibility and leverage resources. It often involves institutional funds, unrecovered indirect costs, or faculty effort.

Question 94: Under the concept of 'cost sharing,' what is the distinction between mandatory and voluntary committed cost sharing?

Mandatory cost sharing is always in-kind; voluntary is always cash
Mandatory is required by the sponsor; voluntary committed is offered by the institution beyond requirements (Correct answer)
Voluntary committed cost sharing is not allowed under federal awards
Mandatory is tracked; voluntary committed does not need to be tracked

Correct answer: Mandatory is required by the sponsor; voluntary committed is offered by the institution beyond requirements

Mandatory cost sharing is required by the sponsor as a condition of the award, while voluntary committed cost sharing is offered by the grantee beyond what is required.

Question 95: Which provision of the Federal Acquisition Regulation (FAR) requires contractors to disclose and manage organizational conflicts of interest?

FAR 52.203-13
FAR 9.5 (Correct answer)
FAR 31.201-2
FAR 52.215-2

Correct answer: FAR 9.5

FAR Subpart 9.5 addresses organizational conflicts of interest and requires agencies to identify, evaluate, and mitigate such conflicts.

Question 96: When an investigational drug is destroyed at a clinical site, what is required to satisfy regulatory documentation standards?

A verbal confirmation from the site pharmacist
IRB signature on a destruction form
Sponsor approval alone via email
A witnessed destruction certificate with lot numbers and quantities (Correct answer)

Correct answer: A witnessed destruction certificate with lot numbers and quantities

Destruction must be documented with a certificate that includes lot numbers, quantities, date, method, and signatures of witnesses.

Question 97: Which of the following best describes 'float' in the context of research administration financial management?

The time difference between when costs are incurred and when they are posted to the ledger (Correct answer)
Unexpended balances at the end of a project period
The difference between direct and indirect costs
Funds transferred between different sponsored projects

Correct answer: The time difference between when costs are incurred and when they are posted to the ledger

Float refers to the lag time between when expenditures are incurred and when they are actually posted to the financial accounting system.

Question 98: A NIH-funded study is halted mid-project due to a campus-wide emergency closure. What should the research administrator do FIRST regarding the award?

Transfer all funds to a reserve account
Submit a final progress report
Terminate the award immediately
Notify the NIH program officer of the disruption as soon as practicable (Correct answer)

Correct answer: Notify the NIH program officer of the disruption as soon as practicable

Prompt notification to the program officer is the first step; sponsors can then provide guidance on allowable costs, extensions, and modified expectations.

Question 99: A research institution's Facilities Condition Index (FCI) is calculated as:

Deferred maintenance cost divided by current replacement value (Correct answer)
Annual maintenance budget divided by total gross square footage
Total operating cost divided by assignable square footage
Capital renewal needs divided by deferred maintenance backlog

Correct answer: Deferred maintenance cost divided by current replacement value

FCI = Deferred Maintenance Cost / Current Replacement Value; a lower FCI (closer to 0) indicates a better facility condition.

Question 100: What does 'burn rate' mean in monitoring a sponsored research project?

The pace at which budgeted funds are being expended relative to the project timeline (Correct answer)
The interest rate charged on advance payments from the sponsor
The rate at which laboratory equipment depreciates
The rate at which F&A costs accumulate on the project

Correct answer: The pace at which budgeted funds are being expended relative to the project timeline

Burn rate measures how quickly a project is spending its budget relative to elapsed time, helping identify over- or under-spending trends.

Question 101: A department administrator completes a cost transfer after the 90-day institutional deadline without proper justification. As the research administrator, your FIRST action is to:

Escalate directly to the federal sponsor
Approve the transfer pending a retroactive justification memo
Reject the transfer and explain that late unjustified transfers are non-compliant (Correct answer)
Process the transfer and note it is late

Correct answer: Reject the transfer and explain that late unjustified transfers are non-compliant

Late cost transfers without adequate justification are a compliance risk; rejecting them and educating the department administrator is the appropriate corrective response.

Question 102: Under Uniform Guidance, which of the following salary charges to a federal award is NOT allowable?

Overtime pay authorized by the award terms
Salary for effort in the months preceding award issuance with pre-award cost approval
Salary exceeding the NIH salary cap for senior/key personnel (Correct answer)
Supplemental pay consistent with institutional written policy

Correct answer: Salary exceeding the NIH salary cap for senior/key personnel

NIH imposes an Executive Level II salary cap; any salary charged to NIH awards above this cap is unallowable and must be borne by the institution.

Question 103: A Cost Accounting Standard (CAS) 502 violation would occur when an institution:

Applies cost accounting practices inconsistently across similar costs (Correct answer)
Exceeds the negotiated indirect cost rate on a federal award
Fails to disclose its cost accounting practices in a written document
Charges direct costs that are also allocated as indirect costs

Correct answer: Applies cost accounting practices inconsistently across similar costs

CAS 502 requires consistent application of cost accounting practices across similar types of costs; inconsistency between sponsored and non-sponsored activities constitutes a violation.

Question 104: Technology Readiness Levels (TRLs) are used in technology transfer to:

Classify research publications by impact factor
Assess the maturity and development stage of a technology for commercialization (Correct answer)
Determine the appropriate royalty rate for licensing agreements
Rank universities by the number of patents they file annually

Correct answer: Assess the maturity and development stage of a technology for commercialization

TRLs (originally developed by NASA, scale 1-9) provide a standardized framework to assess how mature a technology is, from basic research through full commercial deployment.

Question 105: A clinical site receives an investigational drug shipment that arrives at an incorrect temperature. According to GCP, the site should:

Return the shipment without notification
Quarantine the shipment, document the issue, and contact the sponsor before use (Correct answer)
Accept and administer the drug since delays harm subjects
Place the drug in a standard refrigerator and resume normal use

Correct answer: Quarantine the shipment, document the issue, and contact the sponsor before use

Shipments with temperature excursions must be quarantined and the sponsor notified to conduct a stability review before any drug is administered.

Question 106: A university discovers that a PI has been charging personal travel expenses to a federal grant for two years. Under 2 CFR Part 200.405, this is an example of:

An allowable cost that was not adequately documented
A questioned cost pending resolution through the cognizant agency
An unallowable cost that must be removed and may trigger audit findings (Correct answer)
An indirect cost that was incorrectly charged as a direct cost

Correct answer: An unallowable cost that must be removed and may trigger audit findings

Personal expenses are explicitly unallowable under 2 CFR Part 200.405 and the cost principles; they must be removed from the federal award and repaid.

Question 107: A university licenses its patented technology to a startup in which the inventor holds equity. What compliance concern must the institution primarily address?

ITAR export licensing for the technology
Institutional Biosafety Committee review
Financial conflict of interest in both research and technology transfer decisions (Correct answer)
Bayh-Dole march-in rights notification

Correct answer: Financial conflict of interest in both research and technology transfer decisions

When an inventor holds equity in a licensee company, the institution must manage financial conflicts of interest affecting both research objectivity and licensing decisions.

Question 108: A university discovers it has been acting as the lead institution on a multi-site study but never executed formal subaward agreements with participating sites. The primary compliance risk is:

Failure to comply with 2 CFR 200.332 pass-through entity obligations (Correct answer)
Violation of IRB protocol requirements
Breach of the Bayh-Dole Act inventor disclosure requirements
Non-compliance with HIPAA Business Associate requirements

Correct answer: Failure to comply with 2 CFR 200.332 pass-through entity obligations

Without executed subawards, the prime recipient has failed its mandatory pass-through entity obligations under 2 CFR 200.332, including communicating award terms and monitoring subrecipients.

Question 109: Which tool is used to track expenses?

Institutional financial system (Correct answer)
Peer-reviewed journals
Google Sheets
Email updates

Correct answer: Institutional financial system

Institutions manage sponsored project expenses through dedicated financial systems designed for robust accounting, tracking, and reporting. These systems ensure compliance with sponsor regulations, facilitate accurate financial reporting, and provide an auditable record of all transactions. Using such a system is crucial for proper grant management and accountability.

Question 110: Which competency framework is most commonly referenced for developing research administrator professional development plans?

COSO Enterprise Risk Management Framework
SHRM Body of Competency and Knowledge
NCURA Research Administration Competency Model (Correct answer)
PMI Project Management Competency Framework

Correct answer: NCURA Research Administration Competency Model

NCURA's Research Administration Competency Model outlines the knowledge, skills, and abilities specific to the research administration profession.

Question 111: Which of the following actions by a research administrator would constitute a conflict of interest requiring disclosure?

Approving a subcontract to a company in which the administrator holds $6,000 in stock (Correct answer)
Serving on a federal study section for a funding agency
Attending a professional conference funded by the institution
Reviewing grant proposals in a subject area where the administrator has expertise

Correct answer: Approving a subcontract to a company in which the administrator holds $6,000 in stock

Holding a financial interest in a company receiving institutional funds creates a direct conflict of interest that must be disclosed and managed.

Question 112: When documenting activities related to quality assurance & continuous improvement, which practice is considered essential for CRA certification holders?

Maintaining comprehensive records that include procedures, observations, results, and any anomalies (Correct answer)
Recording only outcomes while omitting the methods and processes used
Completing documentation only when requested by auditors or supervisors
Keeping documentation in personal notes that are not accessible to other team members

Correct answer: Maintaining comprehensive records that include procedures, observations, results, and any anomalies

Comprehensive documentation that includes procedures, observations, results, and any anomalies is essential in quality assurance & continuous improvement. This supports quality assurance, enables peer review, and satisfies regulatory and audit requirements.

Question 113: When implementing communication & stakeholder management practices, what should a CRA professional prioritize first?

Compliance with established standards and protocols (Correct answer)
Personal convenience and efficiency
Cost reduction at all levels
Speed of completion over thoroughness

Correct answer: Compliance with established standards and protocols

Compliance with established standards and protocols must be the first priority, as it ensures safety, quality, and legal adherence in professional practice.

Question 114: Which standard of practice is MOST important for ensuring quality in Financial Management & Budgeting?

Using the most advanced technology available regardless of need
Following evidence-based protocols while adapting to specific circumstances (Correct answer)
Strictly adhering to the same procedure in every situation
Minimizing documentation to focus on practical work

Correct answer: Following evidence-based protocols while adapting to specific circumstances

Question 115: In Certified Research Administrator, what role does regulatory compliance & legal framework play in ensuring client/stakeholder satisfaction?

It builds trust through demonstrated competence and consistency (Correct answer)
It only matters during initial certification
It replaces the need for direct communication
It has no direct impact on stakeholder satisfaction

Correct answer: It builds trust through demonstrated competence and consistency

Regulatory Compliance & Legal Framework builds trust through demonstrated competence and consistency, which directly contributes to stakeholder satisfaction and confidence in the CRA professional.

Question 116: A research administrator is building a succession plan for a key grants specialist position. What is the FIRST action?

Wait until the incumbent announces departure plans
Identify high-potential internal candidates and assess their development gaps (Correct answer)
Transfer all institutional knowledge to a shared drive
Post the position externally as a contingency

Correct answer: Identify high-potential internal candidates and assess their development gaps

Succession planning begins with identifying and developing internal talent before a vacancy occurs, not reacting to departures.

Question 117: When a blinded randomized trial requires emergency unblinding for a participant, who should typically be contacted first?

The sponsor or designated emergency unblinding contact (Correct answer)
The IRB
The participant's primary care physician
The data safety monitoring board

Correct answer: The sponsor or designated emergency unblinding contact

Sponsors establish emergency unblinding procedures and should be contacted first through the designated 24-hour contact or code-break envelope process.

Question 118: What is the purpose of a data use agreement?

Pays collaborators
Defines how data is shared and used (Correct answer)
Schedules reports
Tracks grant dates

Correct answer: Defines how data is shared and used

A Data Use Agreement (DUA) is a formal contract that governs the transfer of data between institutions or researchers, particularly when the data contains protected health information (PHI) or other sensitive information. It specifies the terms and conditions for data use, security, and disclosure, ensuring compliance with privacy regulations like HIPAA and ethical data stewardship.

Question 119: What is the significance of peer review in regulatory compliance & legal framework for CRA professionals?

It replaces the need for self-assessment
It is only relevant for newly certified professionals
It promotes accountability, knowledge sharing, and quality improvement (Correct answer)
It is primarily used for disciplinary purposes

Correct answer: It promotes accountability, knowledge sharing, and quality improvement

Peer review promotes accountability, knowledge sharing, and quality improvement by allowing CRA professionals to benefit from collective expertise and identify areas for growth.

Question 120: A research institution is negotiating a Facilities and Administrative (F&A) rate with the federal government. Which federal agency typically leads the negotiation for most research universities?

NIH Office of Policy for Extramural Research Administration
Office of Management and Budget
Department of Health and Human Services (DHHS) Division of Cost Allocation (Correct answer)
NSF Division of Grants and Agreements

Correct answer: Department of Health and Human Services (DHHS) Division of Cost Allocation

The DHHS Division of Cost Allocation (now Cost Determination) is the cognizant federal agency responsible for negotiating F&A rates for most research universities.

Question 121: What is the primary goal of financial management in sponsored programs?

Track PI vacation days
Monitor research publications
Ensure appropriate and compliant use of funds (Correct answer)
Set staff goals

Correct answer: Ensure appropriate and compliant use of funds

The primary goal of financial management in sponsored programs is to ensure that all grant funds are used appropriately, efficiently, and in strict compliance with both the sponsor's regulations and institutional policies. This involves meticulous tracking of expenditures, adherence to budget limits, and proper documentation. Effective financial management safeguards against misuse of funds and ensures audit readiness.

Question 122: Which of the following scenarios represents 'cost shifting' that violates federal regulations?

Charging equipment shared across two projects based on usage
Moving an overdraft on a completed federal grant to another active federal grant (Correct answer)
Transferring pre-award costs after receiving sponsor approval
Charging salary proportional to percent effort

Correct answer: Moving an overdraft on a completed federal grant to another active federal grant

Cost shifting involves moving costs to a federal award that do not properly belong to it, such as transferring overruns from one federal project to cover shortfalls on another.

Question 123: Who is responsible for financial oversight of a grant?

Only the dean
PI and institutional grants office (Correct answer)
Peer reviewers
Only finance office

Correct answer: PI and institutional grants office

Financial oversight of a grant is a shared responsibility between the Principal Investigator (PI) and the institutional grants or sponsored programs office. The PI is responsible for the scientific and programmatic direction and ensuring expenditures are necessary and reasonable for the project. The institutional grants office provides administrative support, ensures compliance with sponsor regulations, and manages the financial reporting and auditing processes.

Question 124: In Resident Rights & Advocacy, what is the FIRST step a CRA professional should take when encountering a new case or situation?

Implement an immediate solution based on past experience
Conduct a comprehensive assessment and gather all relevant information (Correct answer)
Document the situation and wait for further instructions
Consult with a supervisor before taking any action

Correct answer: Conduct a comprehensive assessment and gather all relevant information

In Resident Rights & Advocacy, a thorough initial assessment ensures all relevant factors are identified before deciding on an appropriate course of action. This systematic approach is fundamental to Certified Research Administrator practice.

Question 125: An IRB is reviewing a study that involves recruiting prisoners as research subjects. Under 45 CFR Part 46 Subpart C, which of the following is a required finding?

All research involving prisoners requires Secretarial approval regardless of risk level
The research offers only minimal risk with no prospect of direct benefit
The research presents no more than minimal risk or offers direct benefit to subjects (Correct answer)
A majority of the IRB members must themselves be prisoners or prisoner advocates

Correct answer: The research presents no more than minimal risk or offers direct benefit to subjects

Subpart C requires the IRB to find that the research involves no more than minimal risk, or that it offers direct benefit to the individual prisoner subject, among other required findings.

Question 126: Which of the following activities is specifically exempt from IACUC review under the Animal Welfare Act?

Surgical procedures on rats
Breeding studies for genetically modified mice
Behavioral studies involving food deprivation in mice
Field studies of free-living wild animals that do not involve harm, deprivation, or stress (Correct answer)

Correct answer: Field studies of free-living wild animals that do not involve harm, deprivation, or stress

The Animal Welfare Act exempts field studies of free-living wild animals where the research does not involve invasive procedures or captivity.

Question 127: How should a CRA professional handle a situation where regulatory compliance & legal framework protocols conflict with practical constraints?

Avoid addressing the conflict entirely
Always ignore the protocols in favor of practicality
Make a unilateral decision without consultation
Document the conflict and seek guidance from appropriate authorities (Correct answer)

Correct answer: Document the conflict and seek guidance from appropriate authorities

When protocols conflict with practical constraints, the professional approach is to document the conflict and seek guidance, ensuring transparency and compliance while working toward a resolution.

Question 128: What is a common challenge professionals face when applying communication & stakeholder management principles in Certified Research Administrator?

Balancing theoretical knowledge with practical application (Correct answer)
Excessive simplicity of industry regulations
Lack of any professional development opportunities
Having too much support from colleagues

Correct answer: Balancing theoretical knowledge with practical application

Balancing theoretical knowledge with practical application is a well-recognized challenge, as real-world scenarios often present complexities not covered in standard training.

Question 129: A research administrator discovers that a newly hired staff member misrepresented their grant management experience during hiring. What is the CORRECT course of action?

Provide extra training to compensate for the gap
Allow the probationary period to serve as the only consequence
Notify HR and follow institutional policies regarding misrepresentation (Correct answer)
Ignore it if the employee is performing adequately

Correct answer: Notify HR and follow institutional policies regarding misrepresentation

Misrepresentation on employment applications is a serious integrity issue that must be reported to HR for formal review under institutional policy.

Question 130: In the context of professional standards & ethics, what role does continuous professional development play for CRA practitioners?

It is required only during the first year of certification
It serves primarily as a networking opportunity with no practical benefit
It is optional and only needed for career advancement
It ensures practitioners remain current with evolving standards, technologies, and best practices (Correct answer)

Correct answer: It ensures practitioners remain current with evolving standards, technologies, and best practices

Continuous professional development is essential in professional standards & ethics because it ensures CRA practitioners remain current with evolving standards, technologies, and best practices, maintaining competency throughout their careers.

Question 131: Under the NIH Guidelines, what entity is responsible for approving the construction or renovation of facilities that will house recombinant DNA research?

The Institutional Review Board (IRB)
The Office of Research Integrity
The Environmental Health and Safety Office
The Institutional Biosafety Committee (IBC) (Correct answer)

Correct answer: The Institutional Biosafety Committee (IBC)

The IBC must review and approve facility design for recombinant DNA work to ensure compliance with NIH Guidelines.

Question 132: What is the key distinction between a cooperative agreement and a federal grant under the Federal Grant and Cooperative Agreement Act?

Cooperative agreements are always larger in dollar value than grants
Cooperative agreements are only used for infrastructure projects
Cooperative agreements involve substantial federal agency involvement in the conduct of the project activity (Correct answer)
Grants require competitive bidding while cooperative agreements do not

Correct answer: Cooperative agreements involve substantial federal agency involvement in the conduct of the project activity

The Federal Grant and Cooperative Agreement Act distinguishes cooperative agreements from grants by the presence of substantial agency involvement in project execution.

Question 133: A newly promoted research administrator supervisor is managing former peers for the first time. What is the MOST common challenge they will need to address?

Navigating the shift from peer relationships to supervisory authority (Correct answer)
Understanding federal regulations for the first time
Learning new software systems
Reducing the office's indirect cost rate

Correct answer: Navigating the shift from peer relationships to supervisory authority

The transition from peer to supervisor requires establishing new professional boundaries and credibility without damaging existing collegial relationships.

Question 134: What is the significance of a letter of support?

Shows institutional or collaborator support (Correct answer)
Provides ethical approval
Adds to the budget
Replaces the abstract

Correct answer: Shows institutional or collaborator support

A letter of support is a crucial component of a research proposal as it demonstrates commitment and endorsement from key stakeholders, such as the applicant's institution or collaborating partners. These letters provide evidence that the necessary resources, expertise, and infrastructure are available to support the proposed research. They significantly strengthen the proposal by validating its feasibility and collaborative potential.

Question 135: A subject on a clinical trial self-reports taking an over-the-counter NSAID prohibited by the protocol. The CRA should ensure the site:

Documents the concomitant medication and assesses protocol deviation impact (Correct answer)
Asks the subject to stop but takes no further action
Issues a protocol amendment to allow NSAIDs
Discontinues the subject immediately

Correct answer: Documents the concomitant medication and assesses protocol deviation impact

Use of a prohibited concomitant medication must be documented, assessed for safety impact, and reported as a protocol deviation if required.

Question 136: Under federal regulations, late cost transfers (generally those processed more than 90 days after the original transaction) raise concerns because they:

Are automatically disallowed by the cognizant federal agency
Require approval from the Office of Inspector General
May suggest that costs are being moved to spend down a grant rather than for legitimate correction purposes (Correct answer)
Must be reported on the institution's annual single audit

Correct answer: May suggest that costs are being moved to spend down a grant rather than for legitimate correction purposes

Late cost transfers raise red flags about whether the transfer is a legitimate correction or an attempt to improperly spend down a grant before closeout.

Question 137: What is the PRIMARY purpose of continuing education requirements in Medication Management Oversight for CRA professionals?

Maintaining current knowledge and competency as the field evolves (Correct answer)
Networking with other professionals in the field
Earning additional credentials for career advancement
Fulfilling mandatory regulatory requirements only

Correct answer: Maintaining current knowledge and competency as the field evolves

Continuing education in Medication Management Oversight ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Certified Research Administrator field.

Question 138: A sponsor requires that the proposal be submitted by 5:00 PM Eastern Time. The research administrator's institution is in the Pacific Time zone. What time must the proposal be submitted?

8:00 PM Pacific Time
5:00 PM Pacific Time
3:00 PM Pacific Time
2:00 PM Pacific Time (Correct answer)

Correct answer: 2:00 PM Pacific Time

Eastern Time is 3 hours ahead of Pacific Time, so 5:00 PM ET corresponds to 2:00 PM PT.

Question 139: A research office is implementing a new electronic research administration (eRA) system. Which staff training sequence is MOST effective?

Train superusers first, then cascade training to end-users with superuser support (Correct answer)
Train all staff simultaneously on the full system at launch
Provide system access and rely on staff to self-train via trial and error
Conduct training only after staff report problems using the system

Correct answer: Train superusers first, then cascade training to end-users with superuser support

A superuser cascade model builds internal expertise first, creating peer support networks that make broader rollout training more effective and sustainable.

Question 140: Which federal office is responsible for investigating allegations of research misconduct in PHS-funded research?

Office of Research Integrity (ORI) (Correct answer)
National Science Foundation Office of Inspector General
Office for Human Research Protections (OHRP)
Office of Inspector General (OIG)

Correct answer: Office of Research Integrity (ORI)

The Office of Research Integrity (ORI) oversees and monitors research misconduct investigations at institutions receiving PHS funding.

Question 141: In a research facilities cost study, 'assignable square footage' (ASF) differs from 'gross square footage' (GSF) because ASF:

Excludes non-assignable areas such as corridors, mechanical rooms, and restrooms (Correct answer)
Is always larger than GSF
Includes all interior spaces regardless of use
Represents only laboratory and research spaces

Correct answer: Excludes non-assignable areas such as corridors, mechanical rooms, and restrooms

ASF includes only those spaces assigned to specific functions, while GSF captures all interior areas including circulation and support spaces.

Question 142: A principal investigator wants to rebudget funds from personnel to equipment, exceeding 10% of the total award. What is typically required?

No action needed if costs are allowable
Institutional approval only
Sponsor prior approval (Correct answer)
A budget amendment form filed with the IRB

Correct answer: Sponsor prior approval

Most federal awards require prior approval from the sponsor when a rebudget action exceeds 10% of the total award amount, as specified in 2 CFR Part 200.308.

Question 143: A sponsored project's equipment is damaged in a flood. Which step is essential BEFORE disposing of damaged equipment purchased with federal funds?

Transferring title to the institution's insurance carrier
Notifying the IRB of the equipment loss
Filing a police report for stolen goods
Obtaining sponsor approval or following the agency's disposition requirements (Correct answer)

Correct answer: Obtaining sponsor approval or following the agency's disposition requirements

Federally-funded equipment is subject to disposition requirements under 2 CFR 200.313, and sponsors must be consulted before disposal.

Question 144: Which federal law requires research institutions receiving federal funding to conduct energy audits and implement energy efficiency measures?

The Energy Policy Act of 2005 (Correct answer)
The National Energy Conservation Policy Act
The Resource Conservation and Recovery Act
Executive Order 13514

Correct answer: The Energy Policy Act of 2005

The Energy Policy Act of 2005 established energy reduction goals for federal facilities and institutions receiving federal support.

Question 145: Under Bayh-Dole, a university's obligation to file for patent protection on a subject invention is triggered only if:

The federal agency mandates filing as a condition of award
The technology has already been published in a peer-reviewed journal
The inventor personally requests patent filing within 30 days
The institution elects to retain title to the invention (Correct answer)

Correct answer: The institution elects to retain title to the invention

The Bayh-Dole patent filing obligation arises after the institution has elected title; if the institution chooses not to elect title, the obligation to file does not apply to the institution.

Question 146: Which federal regulation governs the procurement of research and development under federal contracts and distinguishes R&D from standard supply and service contracts?

OMB Circular A-21
FAR Part 35 (Correct answer)
FAR Part 15
2 CFR Part 200

Correct answer: FAR Part 35

FAR Part 35 specifically addresses the procurement of research and development and sets out unique acquisition policies for R&D contracts.

Question 147: Which type of federal audit is required for non-federal entities that expend $750,000 or more in federal awards in a fiscal year?

Single Audit (Uniform Guidance audit) (Correct answer)
Agreed-upon procedures engagement
Program-specific audit
Inspector General audit

Correct answer: Single Audit (Uniform Guidance audit)

A Single Audit under 2 CFR Part 200 Subpart F is required for entities that expend $750,000 or more in federal awards in a fiscal year, covering all federal programs.

Question 148: In a multicenter trial, which document defines the specific roles each staff member may perform related to investigational drug handling?

Delegation of authority log (Correct answer)
Site initiation visit report
Protocol deviation log
Monitoring visit report

Correct answer: Delegation of authority log

The delegation of authority log specifies which qualified staff members are authorized to perform specific study tasks, including drug handling.

Question 149: Which quality improvement method is most applicable to communication & stakeholder management in Certified Research Administrator?

Making changes only when mandated by regulators
Ignoring feedback and maintaining status quo
Implementing changes without measuring outcomes
Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)

Correct answer: Plan-Do-Check-Act (PDCA) continuous improvement cycle

The PDCA cycle is widely recognized as the most effective quality improvement method, allowing CRA professionals to systematically improve communication & stakeholder management practices.

Question 150: A researcher wants to use a Limited Dataset (as defined under HIPAA) for research without obtaining individual authorization. What is required?

Certification that the dataset contains no PHI whatsoever
A Data Use Agreement and IRB waiver of authorization or exempt determination (Correct answer)
Full IRB approval and a signed HIPAA authorization from each subject
Only an IRB waiver of informed consent with no additional agreement needed

Correct answer: A Data Use Agreement and IRB waiver of authorization or exempt determination

A Limited Dataset still contains some indirect identifiers, so HIPAA requires a Data Use Agreement, and the researcher must also address IRB requirements for human subjects research.

Question 151: A research administrator is documenting a performance improvement plan (PIP) for a staff member who missed three consecutive sponsor reporting deadlines. Which element is ESSENTIAL in the PIP?

A list of all past performance issues unrelated to deadline management
Specific, measurable performance objectives with deadlines and consequences clearly stated (Correct answer)
A subjective description of the employee's attitude
A comparison of the employee to higher-performing colleagues

Correct answer: Specific, measurable performance objectives with deadlines and consequences clearly stated

An effective PIP must include specific, measurable objectives and clearly stated consequences to be legally defensible and to give the employee a genuine opportunity to improve.

Question 152: A research administrator is reviewing a grant budget and notices that the PI has included a line item for 'miscellaneous' costs totaling $10,000 with no further explanation. What is the best course of action?

Request that the PI itemize and justify each cost, as 'miscellaneous' is not an acceptable budget category for federal awards (Correct answer)
Accept it since miscellaneous costs are a standard budget category
Move the costs to indirect cost recovery
Reduce the amount to $5,000 to minimize audit risk

Correct answer: Request that the PI itemize and justify each cost, as 'miscellaneous' is not an acceptable budget category for federal awards

Federal sponsors generally do not accept 'miscellaneous' as a budget category; all costs must be specifically identified, justified, and allocable to the project.

Question 153: Under 2 CFR 200.331, before issuing a subaward, a pass-through entity must verify that a prospective subrecipient is not listed on which federal exclusion database?

DUNS database
Federal Audit Clearinghouse
FFATA Subaward Reporting System
SAM.gov System for Award Management (Correct answer)

Correct answer: SAM.gov System for Award Management

SAM.gov is the authoritative federal source for checking whether an entity is suspended, debarred, or otherwise excluded from receiving federal funds.

Question 154: An award is about to close and has $3,000 remaining. The PI wants to purchase supplies that were not in the original scope. What is the most appropriate course of action?

Transfer the funds to another active project
Purchase the supplies since there are funds available
Verify the supplies are within scope; if not, return the funds or consult the sponsor (Correct answer)
Request a no-cost extension to spend the remaining balance

Correct answer: Verify the supplies are within scope; if not, return the funds or consult the sponsor

Remaining funds must be spent only on allowable, allocable costs within the approved scope of work; spending outside scope is improper regardless of fund availability.

Question 155: A sponsor-investigator conducting a Phase I first-in-human study must ensure the investigational drug label includes:

Pharmacokinetic data from animal studies
Statement 'Caution: New Drug — Limited by Federal law to investigational use' (Correct answer)
Full prescribing information as approved for other indications
NDC number and standard retail pricing

Correct answer: Statement 'Caution: New Drug — Limited by Federal law to investigational use'

21 CFR 312.6 requires that investigational drug labels bear the statement limiting use to investigational purposes.

Question 156: A CRA professional encounters an unfamiliar situation while performing quality assurance & continuous improvement duties. What is the most appropriate first action?

Consult relevant standards, guidelines, or a qualified supervisor before proceeding (Correct answer)
Apply a solution from an unrelated field without verification
Skip the task entirely and move to the next assignment
Proceed based on general assumptions to avoid delays

Correct answer: Consult relevant standards, guidelines, or a qualified supervisor before proceeding

When facing unfamiliar situations in quality assurance & continuous improvement, the most appropriate action is to consult relevant standards, guidelines, or a qualified supervisor. This ensures safety, accuracy, and compliance while building professional knowledge.

Question 157: What is the significance of the 'period of performance' on a federal grant?

It establishes the deadline for hiring project personnel
It indicates when performance reviews of grant staff are due
It defines the time frame during which project activities may be conducted and costs may be incurred (Correct answer)
It specifies when the final technical report must be submitted

Correct answer: It defines the time frame during which project activities may be conducted and costs may be incurred

The period of performance defines the authorized timeframe for conducting project activities and incurring allowable costs against the award.

Question 158: In the context of regulatory compliance & legal framework, what role does continuous professional development play for CRA practitioners?

It is optional and only needed for career advancement
It is required only during the first year of certification
It ensures practitioners remain current with evolving standards, technologies, and best practices (Correct answer)
It serves primarily as a networking opportunity with no practical benefit

Correct answer: It ensures practitioners remain current with evolving standards, technologies, and best practices

Continuous professional development is essential in regulatory compliance & legal framework because it ensures CRA practitioners remain current with evolving standards, technologies, and best practices, maintaining competency throughout their careers.

Question 159: A CRA is reviewing subrecipient monitoring files and notices that site visit reports are missing for three high-risk subrecipients. Which federal requirement is most directly at risk of non-compliance?

2 CFR 200.514 requirements for auditor qualifications
2 CFR 200.332(d) requiring pass-through entities to monitor subrecipient activities (Correct answer)
2 CFR 200.412 governing direct cost allocation methods
OMB M-20-26 provisions on grant flexibilities

Correct answer: 2 CFR 200.332(d) requiring pass-through entities to monitor subrecipient activities

2 CFR 200.332 mandates that pass-through entities actively monitor subrecipients, including through site visits for high-risk entities.

Question 160: Under 2 CFR Part 200, the concept of 'allocability' means a cost:

Is permitted under the terms of the award
Is consistent with institutional policies
Benefits the award proportionately and can be assigned with reasonable accuracy (Correct answer)
Does not exceed market rates

Correct answer: Benefits the award proportionately and can be assigned with reasonable accuracy

Allocability requires that a cost be assignable to a federal award in accordance with the relative benefits received, based on reasonable and consistent methods.

Question 161: An institution's FCOI policy must require investigators to disclose significant financial interests that could be affected by PHS-funded research. What is the threshold dollar amount triggering disclosure?

$1,000 in aggregate over the prior 12 months
$25,000 in aggregate over the prior 12 months
$5,000 in aggregate over the prior 12 months (Correct answer)
$10,000 in aggregate over the prior 12 months

Correct answer: $5,000 in aggregate over the prior 12 months

Under 42 CFR Part 50 and 45 CFR Part 94, investigators must disclose significant financial interests exceeding $5,000 in aggregate over the prior 12 months.

Question 162: Which approach BEST supports knowledge retention when training staff on complex federal reporting requirements?

Spaced repetition with scenario-based practice exercises (Correct answer)
Requiring staff to self-study on their own time
Sending a link to the Federal Register
One-time lecture with printed handouts

Correct answer: Spaced repetition with scenario-based practice exercises

Spaced repetition combined with scenario-based exercises promotes deeper understanding and long-term retention of complex regulatory content.

Question 163: A no-cost extension (NCE) allows a grantee to:

Transfer the award to a new principal investigator
Carry forward unspent funds to a different project
Extend the performance period without additional federal funds to complete the work (Correct answer)
Increase the total award budget without sponsor approval

Correct answer: Extend the performance period without additional federal funds to complete the work

A no-cost extension extends the performance period at no additional cost to the sponsor, allowing the grantee to complete the scope of work with existing funds.

Question 164: When a conflict arises between standard procedures and a unique situation in Regulatory Compliance & Licensing, what should a CRA professional prioritize?

The most cost-effective solution available
Strict adherence to written procedures without exception
Safety and ethical obligations while seeking expert consultation (Correct answer)
The preference of the client or stakeholder

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Regulatory Compliance & Licensing. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 165: What is the PRIMARY purpose of continuing education requirements in Quality Assurance Programs for CRA professionals?

Earning additional credentials for career advancement
Networking with other professionals in the field
Fulfilling mandatory regulatory requirements only
Maintaining current knowledge and competency as the field evolves (Correct answer)

Correct answer: Maintaining current knowledge and competency as the field evolves

Continuing education in Quality Assurance Programs ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Certified Research Administrator field.

Question 166: What is indemnification in a research agreement?

Team meeting schedules
Protection from legal liabilities (Correct answer)
Extra budget approval
Publishing support

Correct answer: Protection from legal liabilities

Indemnification is a contractual clause where one party agrees to compensate the other party for losses or damages incurred due to specific actions or inactions related to the agreement. In research, it typically provides protection from legal liabilities, such as claims arising from negligence, intellectual property infringement, or harm caused by the research activities. This clause allocates risk between the parties.

Question 167: A Single Audit finding cites a 'questioned cost' of $45,000. What does this classification mean?

The cost exceeded the approved budget modification threshold
The cost was disallowed and must be returned immediately
The sponsor has formally requested repayment of the amount
The auditor has identified an expenditure that may not comply with applicable requirements and requires resolution (Correct answer)

Correct answer: The auditor has identified an expenditure that may not comply with applicable requirements and requires resolution

A questioned cost is one that the auditor believes may be unallowable, unsupported, or unreasonable, pending resolution by the cognizant federal agency.

Question 168: What is the main distinction between a Certificate of Confidentiality and a confidentiality pledge in a consent form?

A confidentiality pledge provides stronger legal protection than a Certificate of Confidentiality
A Certificate of Confidentiality must be renewed annually by the IRB
A confidentiality pledge is mandated by OHRP while a Certificate is optional researcher discretion
A Certificate of Confidentiality is a federal protection that shields research data from compelled disclosure in legal proceedings (Correct answer)

Correct answer: A Certificate of Confidentiality is a federal protection that shields research data from compelled disclosure in legal proceedings

Certificates of Confidentiality, authorized under 42 USC 241(d), provide legally enforceable protection against compelled disclosure of identifiable research data.

Question 169: What is the role of a 'cognizant federal agency' in the context of an institution's indirect cost rate?

To conduct annual programmatic reviews of all sponsored projects
To negotiate and approve the institution's F&A rate agreement on behalf of all federal agencies (Correct answer)
To approve all individual expenditures above a certain threshold
To certify the institution's human subjects research compliance

Correct answer: To negotiate and approve the institution's F&A rate agreement on behalf of all federal agencies

The cognizant federal agency (typically DHHS or DoD) negotiates and approves the institution's F&A rate on behalf of the federal government, and the resulting rate applies to all federal awards.

Question 170: Under the Export Administration Regulations (EAR), what is the 'fundamental research exclusion' as it applies to universities?

Research conducted on campus by U.S. citizens only is excluded
Basic and applied research where results are intended for publication and freely shared is excluded (Correct answer)
Research not involving controlled technology or foreign nationals is excluded
All federally funded research is automatically excluded from export controls

Correct answer: Basic and applied research where results are intended for publication and freely shared is excluded

The fundamental research exclusion applies to basic and applied research at accredited institutions where results are ordinarily published and shared broadly, with no publication restrictions imposed by sponsors.

Question 171: Which document establishes the basis for negotiating a federally negotiated indirect cost rate with a cognizant federal agency?

Facilities and Administrative (F&A) cost proposal (Correct answer)
Budget justification narrative
Organizational chart
Cost Accounting Standards disclosure statement

Correct answer: Facilities and Administrative (F&A) cost proposal

An F&A cost proposal documents the institution's actual costs for space, utilities, administration, and other overhead, forming the basis for rate negotiation.

Question 172: When documenting activities related to professional standards & ethics, which practice is considered essential for CRA certification holders?

Completing documentation only when requested by auditors or supervisors
Maintaining comprehensive records that include procedures, observations, results, and any anomalies (Correct answer)
Recording only outcomes while omitting the methods and processes used
Keeping documentation in personal notes that are not accessible to other team members

Correct answer: Maintaining comprehensive records that include procedures, observations, results, and any anomalies

Comprehensive documentation that includes procedures, observations, results, and any anomalies is essential in professional standards & ethics. This supports quality assurance, enables peer review, and satisfies regulatory and audit requirements.

Question 173: When a conflict arises between standard procedures and a unique situation in Facility Operations & Maintenance, what should a CRA professional prioritize?

Strict adherence to written procedures without exception
Safety and ethical obligations while seeking expert consultation (Correct answer)
The preference of the client or stakeholder
The most cost-effective solution available

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Facility Operations & Maintenance. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 174: A researcher submits a progress report to NIH that omits a significant adverse event that occurred during the study period. This is best characterized as:

A minor compliance issue handled by departmental review
Research misconduct under the category of falsification (Correct answer)
A protocol deviation subject to IRB notification only
An administrative oversight requiring a corrective action plan

Correct answer: Research misconduct under the category of falsification

Omitting a significant adverse event from a required federal report constitutes falsification of research records, which is a form of research misconduct under federal policy.

Question 175: Which principle from adult learning theory (andragogy) is MOST important to apply when training experienced research administrators on a policy update?

Focusing exclusively on memorization of regulatory text
Treating experienced staff as passive recipients of information
Using the same curriculum designed for entry-level staff
Connecting new policy requirements to participants' prior experience and real work scenarios (Correct answer)

Correct answer: Connecting new policy requirements to participants' prior experience and real work scenarios

Andragogy principles emphasize that adult learners are self-directed and learn best when new material connects to their existing experience and immediate job relevance.

Question 176: Under the NIH salary cap, what happens when a key personnel's institutional base salary exceeds the Executive Level II pay cap?

The excess salary cannot be charged to any federal source
The institution must negotiate a waiver with the NIH Office of Research Integrity
NIH will only reimburse up to the cap amount, but the institution may pay the difference from non-federal funds (Correct answer)
The investigator must reduce their effort to bring the charge under the cap

Correct answer: NIH will only reimburse up to the cap amount, but the institution may pay the difference from non-federal funds

When salary exceeds the NIH pay cap, federal funds reimburse only up to the cap; the institution may supplement from non-federal sources but must not include the supplement in the institutional base salary for effort calculations.

Question 177: A sponsor's IND application for a new oncology drug must include which of the following related to medication management?

Chemistry, manufacturing, and controls (CMC) section (Correct answer)
Site-specific pharmacy SOPs
CRA monitoring schedule
IRB membership list

Correct answer: Chemistry, manufacturing, and controls (CMC) section

The CMC section of an IND describes the drug's composition, manufacture, and controls, establishing the quality standards for investigational use.

Question 178: When must an institution report an unanticipated problem involving risks to subjects or others (UPIRTSO) to OHRP?

Within a reasonable time frame after the IRB determines it meets UPIRTSO criteria (Correct answer)
Within 30 calendar days of the adverse event occurring
Within 5 business days of the PI becoming aware of the problem
Only if the problem results in a subject death or permanent disability

Correct answer: Within a reasonable time frame after the IRB determines it meets UPIRTSO criteria

OHRP expects prompt reporting after the IRB makes its determination that a problem meets UPIRTSO criteria; timelines are institution-specific but must be prompt.

Question 179: In Financial Management & Budgeting, what is the FIRST step a CRA professional should take when encountering a new case or situation?

Implement an immediate solution based on past experience
Consult with a supervisor before taking any action
Conduct a comprehensive assessment and gather all relevant information (Correct answer)
Document the situation and wait for further instructions

Correct answer: Conduct a comprehensive assessment and gather all relevant information

In Financial Management & Budgeting, a thorough initial assessment ensures all relevant factors are identified before deciding on an appropriate course of action. This systematic approach is fundamental to Certified Research Administrator practice.

Question 180: A Data Use Agreement (DUA) is MOST commonly required when transferring which type of research data?

Limited dataset containing dates and geographic subdivisions (Correct answer)
Raw temperature sensor readings
Publicly available census data
De-identified aggregate survey results

Correct answer: Limited dataset containing dates and geographic subdivisions

HIPAA defines a limited dataset as one that retains certain identifiers like dates and geography, requiring a DUA to govern its use.

Question 181: What distinguishes a material weakness from a significant deficiency in the context of a Single Audit under 2 CFR 200?

A material weakness involves dollar amounts over $750,000
A material weakness has a reasonable possibility of resulting in material misstatement of financial statements (Correct answer)
A significant deficiency is limited to compliance findings only
A significant deficiency always requires a corrective action plan

Correct answer: A material weakness has a reasonable possibility of resulting in material misstatement of financial statements

Under auditing standards, a material weakness represents a more severe deficiency where there is a reasonable possibility that a material misstatement will not be prevented or detected.

Question 182: Which scenario best illustrates 'undue inducement' that could compromise voluntary informed consent?

Providing free parking to all study participants as a convenience
Offering a $20 gift card to subjects completing a one-hour online survey
Reimbursing subjects for actual transportation and meal costs
Offering low-income subjects a payment so large relative to their income that it overrides their judgment about acceptable risk (Correct answer)

Correct answer: Offering low-income subjects a payment so large relative to their income that it overrides their judgment about acceptable risk

Undue inducement occurs when payment is so disproportionately large that it impairs rational decision-making about risks, particularly for economically vulnerable populations.

Question 183: Which of the following is an advantage of maintaining a trade secret over seeking patent protection?

Trade secrets can be maintained indefinitely as long as secrecy is preserved (Correct answer)
Trade secrets provide a 20-year term of exclusive legal protection
Trade secrets require public disclosure of the invention
Trade secrets are enforceable against independent third-party discoverers

Correct answer: Trade secrets can be maintained indefinitely as long as secrecy is preserved

Unlike patents which expire after 20 years and require public disclosure, trade secrets can last indefinitely as long as reasonable steps are taken to maintain their confidentiality.

Question 184: The principle of 'respect for persons' in the Belmont Report requires researchers to:

Treat all subjects equally regardless of vulnerability
Distribute research benefits and burdens fairly across populations
Minimize risks and maximize potential benefits to subjects
Acknowledge the autonomy of individuals and protect those with diminished autonomy (Correct answer)

Correct answer: Acknowledge the autonomy of individuals and protect those with diminished autonomy

Respect for persons encompasses both recognizing individual autonomy and providing additional protections for persons with diminished autonomy, such as children or cognitively impaired adults.

Question 185: Which standard of practice is MOST important for ensuring quality in Resident Rights & Advocacy?

Minimizing documentation to focus on practical work
Following evidence-based protocols while adapting to specific circumstances (Correct answer)
Using the most advanced technology available regardless of need
Strictly adhering to the same procedure in every situation

Correct answer: Following evidence-based protocols while adapting to specific circumstances

Question 186: Under 21 CFR Part 11, electronic records and signatures used in FDA-regulated research must meet requirements for:

Trustworthiness, reliability, and equivalence to paper records and handwritten signatures (Correct answer)
Encryption using AES-256 standard and biometric authentication only
Storage on FDA-approved cloud servers with 7-year retention
Real-time audit trails visible to FDA inspectors at all times

Correct answer: Trustworthiness, reliability, and equivalence to paper records and handwritten signatures

21 CFR Part 11 requires that electronic records and signatures be trustworthy, reliable, and generally equivalent in their regulatory standing to paper records and handwritten signatures.

Question 187: Which section of a federal research proposal typically documents the applicant institution's experience, financial stability, and administrative infrastructure?

Research Strategy
Specific Aims
Bibliography
Organizational Capability or Institutional Support (Correct answer)

Correct answer: Organizational Capability or Institutional Support

The Organizational Capability section (sometimes called Institutional Capacity) demonstrates the institution's ability to manage the proposed project successfully.

Question 188: A research administrator notices that a subrecipient is consistently late submitting technical reports. Which monitoring tool under Uniform Guidance is most appropriate to formalize risk mitigation?

Implementing specific conditions or enhanced oversight per 2 CFR 200.208 (Correct answer)
Requesting a grant extension from the prime sponsor
Terminating the subaward for non-compliance
Issuing a stop-work order immediately

Correct answer: Implementing specific conditions or enhanced oversight per 2 CFR 200.208

2 CFR 200.208 authorizes pass-through entities to impose specific conditions on subrecipients identified as higher-risk to improve performance.

Question 189: How does risk management apply to daily practice in Financial Management & Budgeting for Certified Research Administrator professionals?

By avoiding high-risk situations entirely
Through annual safety audits exclusively
Only through responding to incidents after they occur
Through proactive identification of potential hazards and implementation of preventive measures (Correct answer)

Correct answer: Through proactive identification of potential hazards and implementation of preventive measures

Effective risk management in Financial Management & Budgeting requires proactive hazard identification and preventive measures, not just reactive responses. This approach reduces incidents, improves outcomes, and protects both professionals and clients.

Question 190: How should a CRA professional handle a situation where professional standards & ethics protocols conflict with practical constraints?

Avoid addressing the conflict entirely
Document the conflict and seek guidance from appropriate authorities (Correct answer)
Always ignore the protocols in favor of practicality
Make a unilateral decision without consultation

Correct answer: Document the conflict and seek guidance from appropriate authorities

When protocols conflict with practical constraints, the professional approach is to document the conflict and seek guidance, ensuring transparency and compliance while working toward a resolution.

Question 191: An investigator holds $15,000 in stock in a company that makes the device being studied in their NIH-funded research. What FCOI threshold does this exceed?

$50,000 — the federal procurement threshold
$5,000 — the current PHS significant financial interest threshold (Correct answer)
$25,000 — the FDA clinical trial threshold
$10,000 — the NSF reporting threshold

Correct answer: $5,000 — the current PHS significant financial interest threshold

Under 42 CFR Part 50, a significant financial interest in an entity includes equity interests exceeding $5,000 for publicly traded companies.

Question 192: A PI requests a transfer of costs from one federal award to another 90 days after the original charge. The research administrator should:

Require documentation of why the original charge was made in error (Correct answer)
Deny it because transfers after 30 days are always prohibited
Approve it if the amounts are under $500
Process it immediately since it is within 120 days

Correct answer: Require documentation of why the original charge was made in error

Late cost transfers require strong documentation demonstrating the original charge was made in error, not merely as a budget management convenience.

Question 193: Why is timely expense reporting important?

To recruit staff
To meet sponsor audit and reporting requirements (Correct answer)
To apply for new grants
To impress collaborators

Correct answer: To meet sponsor audit and reporting requirements

Timely and accurate expense reporting is crucial for meeting the strict audit and financial reporting requirements imposed by funding sponsors. It ensures that the institution can provide transparent and verifiable documentation of how grant funds were utilized. Delays or inaccuracies can lead to audit findings, penalties, or even the loss of future funding opportunities, jeopardizing the institution's reputation and funding eligibility.

Question 194: Which federal law established the requirement for research institutions receiving PHS funding to have written policies on research misconduct?

The Federal Grant and Cooperative Agreement Act
The Public Health Service Act as amended (42 CFR Part 93) (Correct answer)
The Stevenson-Wydler Technology Innovation Act
The National Research Act of 1974

Correct answer: The Public Health Service Act as amended (42 CFR Part 93)

42 CFR Part 93 implements PHS research misconduct regulations requiring institutions to have policies, procedures, and reporting requirements.

Question 195: An institution experiences a data breach during a cyberattack that disrupts access to grant management systems. This scenario most directly impacts which research administration function?

Animal protocol renewals
Financial reporting and award compliance deadlines (Correct answer)
Institutional Review Board approvals
Patent filing timelines

Correct answer: Financial reporting and award compliance deadlines

Loss of grant management system access directly jeopardizes financial reporting and the ability to meet award compliance deadlines.

Question 196: Which of the following is an example of a detective control in research administration?

Running monthly exception reports to identify costs posted to expired awards (Correct answer)
Training staff on allowable cost principles before project launch
Implementing a system prompt that blocks charges to closed accounts
Requiring dual signatures on purchase orders above $5,000

Correct answer: Running monthly exception reports to identify costs posted to expired awards

Exception reports identify errors or anomalies after transactions have occurred, making them detective rather than preventive controls.

Question 197: A subrecipient under a federal pass-through award is BEST described as:

A vendor providing goods or services under a procurement contract
An institution providing equipment to the prime recipient
An entity that receives a subaward to carry out part of a federal program's substantive scope of work (Correct answer)
A consultant hired by the PI for technical advice

Correct answer: An entity that receives a subaward to carry out part of a federal program's substantive scope of work

A subrecipient is an entity receiving a subaward to perform substantive programmatic work under the federal award, as distinguished from a contractor/vendor.

Question 198: When a clinical trial participant returns unused blister packs of study drug, the site should:

Redistribute them to other trial participants
Dispose of them in the regular pharmacy waste
Count, record returned quantities in the drug accountability log, and store or destroy per protocol (Correct answer)
Send them to the sponsor immediately without logging

Correct answer: Count, record returned quantities in the drug accountability log, and store or destroy per protocol

Returned study drug must be counted, documented in the accountability log, and handled (stored or destroyed) according to the protocol and sponsor instructions.

Question 199: Which method of allocating indirect costs uses a base that excludes equipment, capital expenditures, and subcontract amounts exceeding $25,000?

Total Direct Costs (TDC)
Modified Total Direct Costs (MTDC) (Correct answer)
Total Expenditure base
Salaries and Wages base

Correct answer: Modified Total Direct Costs (MTDC)

MTDC (Modified Total Direct Costs) excludes equipment, capital expenditures, patient care costs, tuition remission, and subcontract amounts above $25,000.

Question 200: Under the Uniform Guidance, a program-specific audit is conducted when an auditee expends federal awards under only one federal program. What is the dollar threshold that triggers any Single Audit requirement?

$500,000 in federal expenditures per year
$750,000 in federal expenditures per year (Correct answer)
$250,000 in federal expenditures per year
$1,000,000 in federal expenditures per year

Correct answer: $750,000 in federal expenditures per year

2 CFR 200.501 establishes $750,000 as the annual federal expenditure threshold above which a Single Audit or program-specific audit is required.

Question 201: Which requirement under the Research Policy Handbook relates to responsible stewardship and mandates that data supporting federally funded research publications be publicly accessible?

All of the above represent applicable federal open access requirements (Correct answer)
NIH Public Access Policy (requiring PMC deposit of peer-reviewed publications)
OSTP memo on increasing public access to federally funded research results
NSF Data Management Plan requirement

Correct answer: All of the above represent applicable federal open access requirements

Multiple federal policies — NIH's Public Access Policy, NSF's DMP requirement, and the OSTP memo — collectively mandate public access to federally funded research outputs.

Question 202: An institution discovers a significant financial conflict of interest (FCOI) on an active NIH grant mid-project. What is the required timeline for reporting to NIH?

Before the next competing renewal
At the next annual progress report
Within 30 days of identification
Within 60 days of identification (Correct answer)

Correct answer: Within 60 days of identification

Under 42 CFR Part 50 Subpart F, institutions must report identified FCOIs to NIH within 60 days and implement a management plan.

Question 203: A researcher charges $500 in lab supplies to a federal grant two days before the project end date, but the supplies are not received until three weeks after the end date. This charge is most likely:

Allowable if approved by the department chair
Unallowable because goods must be received within the project period (Correct answer)
Unallowable only if it exceeds the budget line item
Allowable because it was obligated before the end date

Correct answer: Unallowable because goods must be received within the project period

Costs must generally be incurred within the project period; supplies received after the end date do not meet this requirement even if ordered earlier.

Question 204: When a sponsor-investigator holds an IND, who bears primary regulatory responsibility for the conduct of the clinical investigation?

The IRB that approved the study protocol
The institution's research compliance office
The FDA division overseeing the application
The sponsor-investigator themselves (Correct answer)

Correct answer: The sponsor-investigator themselves

A sponsor-investigator combines both sponsor and investigator responsibilities under 21 CFR Parts 312 and 50, making them solely responsible for regulatory compliance.

Question 205: Which quality improvement method is most applicable to professional standards & ethics in Certified Research Administrator?

Implementing changes without measuring outcomes
Ignoring feedback and maintaining status quo
Making changes only when mandated by regulators
Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)

Correct answer: Plan-Do-Check-Act (PDCA) continuous improvement cycle

The PDCA cycle is widely recognized as the most effective quality improvement method, allowing CRA professionals to systematically improve professional standards & ethics practices.

Question 206: The term 'program income' in sponsored research refers to:

Matching funds provided by a non-federal third party
Funds carried over from a prior budget period
Overhead recovered from federal awards
Gross income earned by the recipient directly generated by a supported activity (Correct answer)

Correct answer: Gross income earned by the recipient directly generated by a supported activity

Program income is gross income earned by a recipient that is directly generated by a supported activity or earned as a result of the federal award during the period of performance.

Question 207: Which technology trend is most likely to impact regulatory compliance & legal framework in the CRA field in coming years?

Return to exclusively paper-based systems
Complete elimination of human professionals
Digital tools for enhanced data collection, analysis, and reporting (Correct answer)
Reduction in the need for professional certification

Correct answer: Digital tools for enhanced data collection, analysis, and reporting

Digital tools for enhanced data collection, analysis, and reporting represent the most significant and practical technology trend impacting regulatory compliance & legal framework, augmenting rather than replacing professional expertise.

Question 208: A PI wants to conduct an international research study in a country that has no local IRB or ethics review process. Under U.S. federal regulations, the research must:

Obtain approval from the U.S. Department of State before proceeding
Be reviewed only by the U.S. institution's IRB, applying U.S. standards
Comply with local laws and customs, with the U.S. IRB verifying that protections are 'at least equivalent' (Correct answer)
Be exempt from review since no local process exists

Correct answer: Comply with local laws and customs, with the U.S. IRB verifying that protections are 'at least equivalent'

OHRP guidance requires that international research comply with local laws and that the U.S. IRB determine that protections afford at least equivalent protections to those in 45 CFR Part 46.

Question 209: Under FEMA's Comprehensive Preparedness Guide (CPG 101), the planning process for institutions should be:

Delegated entirely to the safety office
Top-down with senior leadership dictating all plan elements
Limited to department heads and legal counsel
Collaborative, involving stakeholders from across the organization (Correct answer)

Correct answer: Collaborative, involving stakeholders from across the organization

CPG 101 emphasizes a collaborative, whole-community planning process that incorporates diverse stakeholder input for more effective and realistic plans.

Question 210: An institution is audited and a questioned cost is identified on a federal grant. Under 2 CFR 200, what is the institution's obligation once a final audit determination finds the cost unallowable?

Terminate the affected grant program immediately
Negotiate a reduction in indirect cost rates for future grants
Repay the federal agency the disallowed cost amount (Correct answer)
Submit a corrective action plan within 12 months

Correct answer: Repay the federal agency the disallowed cost amount

When a final determination disallows a cost, the non-Federal entity must repay the disallowed amount to the federal awarding agency.

Question 211: Which method of effort reporting requires employees to report the percentage of time spent on each activity after the fact?

Planned Confirmation System
Institutional Base Salary method
Personnel Activity Reports (PARs) (Correct answer)
After-the-fact activity records

Correct answer: Personnel Activity Reports (PARs)

Personnel Activity Reports (PARs) are after-the-fact records completed by employees documenting the percentage of total compensated activity dedicated to each project.

Question 212: Which regulatory authority must approve an Investigational New Drug (IND) application before human subjects can receive an experimental drug in the United States?

The U.S. Food and Drug Administration (FDA) (Correct answer)
The National Institutes of Health (NIH)
The Office for Human Research Protections (OHRP)
The Department of Defense (DoD) Human Research Protection Office

Correct answer: The U.S. Food and Drug Administration (FDA)

The FDA must receive and allow an IND application to proceed before any experimental drug can be administered to human research subjects in the U.S.

Question 213: A sponsored project budget includes $50,000 for equipment installation in a campus building. How should this cost typically be classified?

Indirect cost recovered through the F&A rate
Direct cost — facilities and administrative
Unallowable cost under 2 CFR 200
Capital expenditure requiring prior sponsor approval (Correct answer)

Correct answer: Capital expenditure requiring prior sponsor approval

Equipment installation costs tied to a specific sponsored project are direct costs but often require prior sponsor approval when they meet capitalization thresholds.

Question 214: Export controls most commonly applicable to technology transfer activities include which of the following regulations?

FERPA and HIPAA
EAR (Export Administration Regulations) and ITAR (International Traffic in Arms Regulations) (Correct answer)
The Davis-Bacon Act and Service Contract Act
OMB Circular A-133 and 2 CFR 200

Correct answer: EAR (Export Administration Regulations) and ITAR (International Traffic in Arms Regulations)

EAR (administered by Commerce) and ITAR (administered by State) govern the export of dual-use and defense-related technologies respectively, and are critical considerations in technology transfer and international collaborations.

Question 215: A research administrator reviewing a budget discovers the protocol requires a specialized pharmacy preparation not covered in the sponsor's per-visit fee. The administrator should:

Bill the subject's insurance without sponsor knowledge
Delete the pharmacy step from the protocol
Absorb the cost as an institutional obligation
Negotiate a budget amendment with the sponsor to cover the pharmacy preparation cost (Correct answer)

Correct answer: Negotiate a budget amendment with the sponsor to cover the pharmacy preparation cost

Uncovered pharmacy preparation costs must be negotiated into the study budget through a contract amendment to ensure financial sustainability and compliance.

Question 216: Why is IRB approval important in research involving humans?

To get more funding
To skip consent
To reduce research time
To protect the rights and safety of participants (Correct answer)

Correct answer: To protect the rights and safety of participants

Institutional Review Board (IRB) approval is paramount in research involving human subjects because its primary purpose is to safeguard the rights, welfare, and safety of participants. The IRB reviews research protocols to ensure ethical conduct, minimize risks, and confirm that informed consent procedures are adequate, thereby upholding ethical standards in research.

Question 217: A contractor needs to add a new work requirement that was not in the original contract scope. Under FAR, which document formally authorizes this change?

A bilateral contract modification (Correct answer)
A unilateral change order by the contractor
An email confirmation from the program officer
A letter of intent from the contracting officer

Correct answer: A bilateral contract modification

A bilateral contract modification, signed by both parties, is required to formally authorize changes to contract scope, price, or terms.

Question 218: A research pharmacist discovers that temperature logs for a biologic study drug show two days of out-of-range storage. What is the most appropriate immediate action?

Continue using the drug and note the deviation
Adjust the logs to reflect acceptable temperatures
Quarantine the affected lot and notify the sponsor (Correct answer)
Discard the drug and resume with new supply

Correct answer: Quarantine the affected lot and notify the sponsor

Out-of-range storage requires quarantining the affected product and promptly notifying the sponsor for stability assessment.

Question 219: In a research space utilization study, a room that is used less than 35% of scheduled hours is typically classified as:

Vacant space that must be returned to the state
Underutilized space eligible for reassignment or consolidation (Correct answer)
Surplus space that cannot be included in indirect cost calculations
Efficiently utilized space

Correct answer: Underutilized space eligible for reassignment or consolidation

Space used below the threshold (commonly 35-40% of scheduled hours) is flagged as underutilized and may be subject to reassignment or consolidation to improve cost efficiency.

Question 220: What is the primary purpose of an investigational drug accountability reconciliation performed at study closeout?

To confirm all dispensed, returned, and destroyed drug quantities match dispensing records (Correct answer)
To calculate per-subject drug costs for the budget
To prepare the final clinical study report
To update the IND application

Correct answer: To confirm all dispensed, returned, and destroyed drug quantities match dispensing records

Closeout reconciliation verifies that all investigational product is accounted for, ensuring no drug was diverted or misused.

Question 221: What documentation practice is considered essential in Staff Management & Training within the Certified Research Administrator field?

Recording actions, observations, and outcomes in real-time or as close to the event as possible (Correct answer)
Using shorthand notes that can be expanded later if needed
Completing all documentation at the end of the workday
Only documenting unusual events or complications

Correct answer: Recording actions, observations, and outcomes in real-time or as close to the event as possible

Real-time or near-real-time documentation in Staff Management & Training ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 222: What makes an abstract effective?

Extensive technical jargon
References to prior work
Clear summary of objectives and methods (Correct answer)
Budget details only

Correct answer: Clear summary of objectives and methods

An effective abstract provides a concise yet comprehensive summary of the entire research proposal, typically outlining the main objectives, the methodology to be employed, and the expected outcomes or significance. It serves as a standalone overview that allows reviewers to quickly grasp the essence of the project. Clarity and brevity are key to capturing the reviewer's interest and conveying the proposal's core message.

Question 223: What is a 'continuity of operations plan' (COOP) designed to ensure?

Laboratory inventories are maintained accurately
Compliance audits are completed on schedule
Funding continuity for multi-year grants
Essential functions continue during and after a disruption (Correct answer)

Correct answer: Essential functions continue during and after a disruption

A COOP ensures that an organization's essential functions can continue during and after emergencies or disruptions.

Question 224: When a conflict arises between standard procedures and a unique situation in Staff Management & Training, what should a CRA professional prioritize?

The preference of the client or stakeholder
The most cost-effective solution available
Safety and ethical obligations while seeking expert consultation (Correct answer)
Strict adherence to written procedures without exception

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Staff Management & Training. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 225: A research administrator discovers $5,000 was erroneously charged to the wrong grant. What is the correct course of action?

Write off the cost as an administrative error with no further action
Leave it on the grant since the amounts are small
Process a cost transfer with appropriate documentation and justification within a timely period (Correct answer)
Move the cost to the departmental account without documentation

Correct answer: Process a cost transfer with appropriate documentation and justification within a timely period

Cost transfers must be processed promptly, documented with a clear business reason, and require appropriate approvals to correct erroneous charges.

Question 226: When a conflict arises between standard procedures and a unique situation in Emergency Preparedness & Safety, what should a CRA professional prioritize?

The preference of the client or stakeholder
Strict adherence to written procedures without exception
The most cost-effective solution available
Safety and ethical obligations while seeking expert consultation (Correct answer)

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Emergency Preparedness & Safety. When standard procedures don't adequately address a unique situation, consulting with experienced colleagues or supervisors ensures both safety and professional standards are maintained.

Question 227: The Federal Acquisition Regulation (FAR) applies to research agreements when:

The federal government is acquiring a product or service for its direct benefit and use (procurement contract) (Correct answer)
The agreement is classified as a grant under 2 CFR Part 200
Any federal agency provides funding exceeding $500,000
The institution receives cooperative agreement funding with substantial involvement

Correct answer: The federal government is acquiring a product or service for its direct benefit and use (procurement contract)

FAR applies to procurement contracts where the government acquires goods or services for its own use, whereas grants and cooperative agreements are governed by 2 CFR Part 200.

Question 228: A CRA professional encounters an unfamiliar situation while performing professional standards & ethics duties. What is the most appropriate first action?

Apply a solution from an unrelated field without verification
Consult relevant standards, guidelines, or a qualified supervisor before proceeding (Correct answer)
Proceed based on general assumptions to avoid delays
Skip the task entirely and move to the next assignment

Correct answer: Consult relevant standards, guidelines, or a qualified supervisor before proceeding

When facing unfamiliar situations in professional standards & ethics, the most appropriate action is to consult relevant standards, guidelines, or a qualified supervisor. This ensures safety, accuracy, and compliance while building professional knowledge.

Question 229: What is the primary purpose of effort reporting in federally sponsored research?

To document hours worked for payroll purposes
To report the number of publications produced per effort unit
To certify that the proportion of effort charged to a grant matches the actual effort expended (Correct answer)
To track overtime hours for sponsored project staff

Correct answer: To certify that the proportion of effort charged to a grant matches the actual effort expended

Effort reporting certifies that salaries charged to federal awards correspond to the actual proportional effort devoted to those projects.

Question 230: Which financial report is typically required at the close of a federal grant to document expenditures?

SF-269 (Financial Status Report)
SF-270 (Request for Advance or Reimbursement)
SF-425 (Federal Financial Report) (Correct answer)
SF-424 (Application for Federal Assistance)

Correct answer: SF-425 (Federal Financial Report)

The SF-425 Federal Financial Report is the standard form used to report expenditures at grant closeout and for interim financial reporting.

Question 231: To prevent medication errors in clinical trials, the site SOP should specify that investigational product dispensing is performed by:

Only a licensed pharmacist or qualified designee per state law (Correct answer)
Any qualified study staff member after training
A sponsor representative during site visits only
The Principal Investigator personally

Correct answer: Only a licensed pharmacist or qualified designee per state law

State pharmacy laws and GCP require that investigational drug dispensing be performed by or under the supervision of a licensed pharmacist.

Question 232: Under 21 CFR Part 312, which of the following is NOT an investigator obligation related to investigational drugs?

Supervising the use of the drug by study staff
Ensuring the drug is used only as directed by the protocol
Manufacturing the drug at the clinical site (Correct answer)
Maintaining adequate records of drug disposition

Correct answer: Manufacturing the drug at the clinical site

Investigators are not responsible for manufacturing investigational drugs; that obligation falls on the sponsor under GMP requirements.

Question 233: What is the purpose of a budget justification in a federal grant proposal?

To summarize the total costs requested
To explain why each line item is necessary and how costs were calculated (Correct answer)
To list the institution's negotiated F&A rate
To certify that costs comply with 2 CFR 200

Correct answer: To explain why each line item is necessary and how costs were calculated

A budget justification provides narrative explanation for each cost item, demonstrating necessity and explaining the methodology for cost calculation.

Question 234: What is the role of a compliance officer?

Ensure ethical and legal research practices (Correct answer)
Manage lab meetings
Assign journal reviewers
Write publications

Correct answer: Ensure ethical and legal research practices

A compliance officer in research administration is responsible for ensuring that all research activities adhere to relevant ethical guidelines, institutional policies, and federal, state, and local regulations. Their role involves developing and implementing compliance programs, conducting training, and monitoring adherence to prevent misconduct and ensure responsible conduct of research.

Question 235: What ethical consideration is most relevant to professional standards & ethics in CRA practice?

Following only those rules that are convenient
Maintaining confidentiality and acting in the best interest of stakeholders (Correct answer)
Avoiding all professional development activities
Prioritizing personal advancement over professional duties

Correct answer: Maintaining confidentiality and acting in the best interest of stakeholders

Maintaining confidentiality and acting in the best interest of stakeholders is the cornerstone ethical consideration for professional standards & ethics in professional practice.

Question 236: Which quality improvement method is most applicable to regulatory compliance & legal framework in Certified Research Administrator?

Ignoring feedback and maintaining status quo
Implementing changes without measuring outcomes
Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)
Making changes only when mandated by regulators

Correct answer: Plan-Do-Check-Act (PDCA) continuous improvement cycle

The PDCA cycle is widely recognized as the most effective quality improvement method, allowing CRA professionals to systematically improve regulatory compliance & legal framework practices.

Question 237: Under the Bayh-Dole Act, what must a contractor do if it decides not to retain title to a federally funded invention?

License the invention exclusively to a domestic entity
Destroy all records related to the invention
Notify the federal agency and allow the government to obtain title (Correct answer)
Publish the invention details within 60 days

Correct answer: Notify the federal agency and allow the government to obtain title

If a contractor elects not to retain title, it must notify the funding agency, which then has the right to obtain patent rights.

Question 238: Which mechanism allows a legally authorized representative (LAR) to provide permission for a cognitively impaired adult to participate in research?

Court-ordered mandatory participation
Waiver of consent granted automatically by the IRB
Blanket institutional approval for all incapacitated subjects
Surrogate consent based on substituted judgment or best interests standard (Correct answer)

Correct answer: Surrogate consent based on substituted judgment or best interests standard

An LAR may provide surrogate consent using substituted judgment (what the subject would have wanted) or best interests when the subject cannot consent independently.

Question 239: What is the purpose of a 'rate agreement' negotiated with the federal government for an academic institution?

To determine the maximum number of federal awards the institution may hold simultaneously
To approve the institution's accounting system as compliant with federal standards
To establish the approved indirect cost (F&A) rates that can be applied to sponsored awards (Correct answer)
To set limits on the salaries that can be charged to federal awards

Correct answer: To establish the approved indirect cost (F&A) rates that can be applied to sponsored awards

A negotiated rate agreement (typically with DHHS or ONR) establishes the approved F&A (Facilities and Administrative) rates an institution may charge to its federal awards.

Question 240: The 'three Rs' framework in animal research (Replacement, Reduction, Refinement) is required to be considered by the IACUC under which federal law?

Animal Welfare Act and its implementing USDA regulations
Public Health Service Act and PHS Policy on Humane Care and Use of Laboratory Animals
FDA's Good Laboratory Practice regulations for non-clinical studies
Both the PHS Policy and the Animal Welfare Act independently require consideration of the three Rs (Correct answer)

Correct answer: Both the PHS Policy and the Animal Welfare Act independently require consideration of the three Rs

Both the PHS Policy (for PHS-funded research) and the Animal Welfare Act regulations (for regulated species) require IACUC consideration of alternatives, minimizing animal numbers, and refining procedures.

Question 241: Under 45 CFR Part 46, which category of research with children qualifies for expedited review involving greater than minimal risk but presenting the prospect of direct benefit?

46.404
46.405 (Correct answer)
46.407
46.406

Correct answer: 46.405

45 CFR 46.405 covers research involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

Question 242: What is the primary purpose of the System for Award Management (SAM) registration requirement for federal grant recipients?

To establish eligibility to receive federal awards and report subaward data (Correct answer)
To verify institutional tax-exempt status
To register intellectual property with the federal government
To certify compliance with the Davis-Bacon Act

Correct answer: To establish eligibility to receive federal awards and report subaward data

SAM registration is required to receive federal awards and to comply with Federal Funding Accountability and Transparency Act (FFATA) reporting obligations.

Question 243: In a sponsored research agreement, an option-to-license provision typically grants the sponsor:

Immediate exclusive rights to all inventions made under the agreement
The right to negotiate a license to sponsor-funded inventions within a defined period (Correct answer)
Veto power over the university's invention disclosure process
Co-ownership of all patents filed during the agreement term

Correct answer: The right to negotiate a license to sponsor-funded inventions within a defined period

An option-to-license provision gives the sponsor a time-limited right to negotiate and execute a license for inventions arising from the sponsored research before the university offers them to other parties.

Question 244: Why is data confidentiality important?

To protect participant privacy (Correct answer)
To secure equipment
To avoid email leaks
To avoid citations

Correct answer: To protect participant privacy

Data confidentiality is crucial in research, especially when dealing with sensitive information from human subjects. It ensures that identifiable information collected from participants is protected from unauthorized access, disclosure, or misuse. Maintaining confidentiality is an ethical obligation and a legal requirement to safeguard participant privacy and trust.

Question 245: How should a CRA professional handle a situation where communication & stakeholder management protocols conflict with practical constraints?

Document the conflict and seek guidance from appropriate authorities (Correct answer)
Avoid addressing the conflict entirely
Make a unilateral decision without consultation
Always ignore the protocols in favor of practicality

Correct answer: Document the conflict and seek guidance from appropriate authorities

When protocols conflict with practical constraints, the professional approach is to document the conflict and seek guidance, ensuring transparency and compliance while working toward a resolution.

Question 246: A consortium research agreement involves three universities sharing data and IP. Which governance document typically controls how IP ownership and revenue sharing are allocated?

Subaward agreement
Memorandum of Understanding
Consortium Agreement (Correct answer)
Data Use Agreement

Correct answer: Consortium Agreement

A Consortium Agreement sets out IP ownership, publication rights, and revenue sharing among multiple institutional partners in a research collaboration.

Question 247: A university receives a subaward from a prime recipient. Under 2 CFR 200.332, the pass-through entity must provide the subrecipient with all of the following EXCEPT:

The CFDA number and title
The period of performance
Applicable terms and conditions of the prime award
A fixed-price subaward budget (Correct answer)

Correct answer: A fixed-price subaward budget

2 CFR 200.332 requires the pass-through entity to communicate specific information to subrecipients but does not mandate a fixed-price subaward structure.

Question 248: When a federally funded research agreement includes export control restrictions under EAR, which action is MOST important before adding a foreign national to the research team?

Submitting a visa sponsorship application
Notifying the IRB of the personnel change
Obtaining written consent from the foreign national
Conducting a deemed export review (Correct answer)

Correct answer: Conducting a deemed export review

Sharing controlled technology with a foreign national in the U.S. constitutes a deemed export, requiring a license review before the individual accesses controlled information.

Question 249: Which document must be maintained to verify that all dispensed investigational drug quantities are accounted for at a clinical site?

Subject enrollment log
Delegation of authority log
Drug accountability log (Correct answer)
Adverse event narrative

Correct answer: Drug accountability log

The drug accountability log tracks dispensing, returns, and destruction, enabling reconciliation of all investigational product.

Question 250: A subcontractor on a federally funded research project discovers a conflict of interest involving the PI. Under 2 CFR 200.112, who bears primary responsibility for managing this conflict?

The PI's department chair
The subcontractor institution
The federal awarding agency
The prime recipient institution (Correct answer)

Correct answer: The prime recipient institution

The prime recipient (pass-through entity) is responsible for ensuring subrecipients comply with conflict of interest requirements under 2 CFR 200.112.

Certified Research Administrator (CRA) Exam

The CRA examination certifies individuals who demonstrate a comprehensive understanding of research administration, encompassing all aspects from proposal development to project closeout.

250

Questions

240 min

Time Limit

70%

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