Certified Research Administrator (CRA) Exam — Questions and Answers

Question 1: Which financial report is typically required at the close of a federal grant to document expenditures?

SF-425 (Federal Financial Report) (Correct answer)
SF-269 (Financial Status Report)
SF-270 (Request for Advance or Reimbursement)
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 2: In a sponsored research agreement, an option-to-license provision typically grants the sponsor:

Co-ownership of all patents filed during the agreement term
Veto power over the university's invention disclosure process
The right to negotiate a license to sponsor-funded inventions within a defined period (Correct answer)
Immediate exclusive rights to all inventions made under the agreement

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 3: Under 2 CFR 200, the use rate for institution-owned equipment charged to federal awards must be based on:

Historical cost and the useful life of the equipment (Correct answer)
The original purchase price of the equipment
Annual depreciation as determined by the sponsor
The current market replacement value

Correct answer: Historical cost and the useful life of the equipment

2 CFR 200.436 requires depreciation charges to be based on the acquisition cost and the useful life of the asset.

Question 4: 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?

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

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 5: A grant-funded research project involves Select Agents. Which federal program must the institution register with?

EPA Chemical Safety Office
OSHA Biological Hazards Division
NIH Office of Science Policy
CDC/USDA Federal Select Agent Program (Correct answer)

Correct answer: CDC/USDA Federal Select Agent Program

The CDC/USDA Federal Select Agent Program oversees the possession, use, and transfer of biological select agents and toxins.

Question 6: A proposal submitted to the Department of Defense includes sensitive technology. Which regulatory framework governs export control considerations for this proposal?

2 CFR Part 200
EAR (Export Administration Regulations) and ITAR (International Traffic in Arms Regulations) (Correct answer)
FERPA
HIPAA

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

EAR and ITAR govern the transfer of controlled technologies, data, and equipment to foreign nationals or governments, which is a key compliance area for defense-related research.

Question 7: 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
3:00 PM Pacific Time
5:00 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 8: In Regulatory Compliance & Licensing, what is the FIRST step a CRA professional should take when encountering a new case or situation?

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

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

In Regulatory Compliance & Licensing, 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 9: A CRA professional encounters an unfamiliar situation while performing regulatory compliance & legal framework duties. What is the most appropriate first action?

Proceed based on general assumptions to avoid delays
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

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 10: When a conflict arises between standard procedures and a unique situation in Medication Management Oversight, what should a CRA professional prioritize?

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

Correct answer: Safety and ethical obligations while seeking expert consultation

Safety and ethics always take priority in Medication Management Oversight. 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 11: Under federal regulations, late cost transfers (generally those processed more than 90 days after the original transaction) raise concerns because they:

Require approval from the Office of Inspector General
Are automatically disallowed by the cognizant federal agency
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 12: 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?

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

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 13: 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 14: When must a research institution report a theft or loss of Select Agents to the CDC?

Immediately, but no later than 24 hours of discovery (Correct answer)
Within 7 calendar days
Within 72 hours of discovery
At the next scheduled reporting period

Correct answer: Immediately, but no later than 24 hours of discovery

Federal Select Agent Program regulations require immediate notification to the CDC, with written follow-up no later than 24 hours after discovery of theft or loss.

Question 15: What is a common challenge professionals face when applying communication & stakeholder management principles in Certified Research Administrator?

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

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

Allowing children over age 12 to sign the adult consent form independently
Obtaining a parent's written permission and treating it as equivalent to child consent
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)

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

Implementing changes without measuring outcomes
Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)
Ignoring feedback and maintaining status quo
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 communication & stakeholder management practices.

Question 18: Which of the following is an example of 'salami slicing' in research publication ethics?

Dividing one study's findings into the smallest possible number of separate publications to maximize output (Correct answer)
Submitting the same manuscript to two journals simultaneously
Including a co-author who did not contribute to the research
Publishing a dataset without disclosing the funding source

Correct answer: Dividing one study's findings into the smallest possible number of separate publications to maximize output

Salami slicing refers to fragmenting the results of a single study into multiple publications to artificially inflate the publication record, which is considered a questionable research practice.

Question 19: Which type of biosafety cabinet provides personnel, environmental, AND product protection?

Laminar flow hood
Class III
Class I
Class II (Correct answer)

Correct answer: Class II

Class II biosafety cabinets provide simultaneous protection for personnel, the environment, and the product being handled.

Question 20: 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)
Post the position externally as a contingency
Transfer all institutional knowledge to a shared drive

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 21: 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 22: Which of the following costs is typically unallowable under federal grants per 2 CFR 200?

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

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 23: What is the purpose of conducting a 'tabletop exercise' in emergency preparedness planning?

To physically test building evacuation routes under real conditions
To audit financial reserves available for disaster recovery
To discuss and analyze emergency scenarios in a low-stress, facilitated discussion (Correct answer)
To train first responders in hands-on field procedures

Correct answer: To discuss and analyze emergency scenarios in a low-stress, facilitated discussion

Tabletop exercises are facilitated discussions of emergency scenarios that help participants identify gaps in plans without physical deployment.

Question 24: 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?

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

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

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

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 26: An NSF-funded researcher relocates to a different university mid-grant. What is the primary administrative action required to continue the grant at the new institution?

A grant transfer (change of grantee organization) must be approved by NSF (Correct answer)
The grant is automatically terminated and the PI reapplies
The original institution retains the grant and hires a new PI
The PI must apply for a new competing grant at the new institution

Correct answer: A grant transfer (change of grantee organization) must be approved by NSF

Grant transfers require NSF approval to move the award from the original awardee institution to the PI's new institution.

Question 27: A research team realizes mid-study that they need to collect additional biological specimens not described in the approved protocol. Before proceeding, they must:

Proceed if the PI determines the change poses no additional risk
Obtain verbal consent from subjects and document it in the case file
Submit a protocol amendment and receive IRB approval before collecting specimens (Correct answer)
Notify the IRB within 30 days as a protocol deviation

Correct answer: Submit a protocol amendment and receive IRB approval before collecting specimens

Any change to an approved protocol that increases risk or alters procedures requires submission of a protocol amendment and IRB approval prior to implementation.

Question 28: Which element is MOST critical to include in a position description for a research compliance specialist role?

Preferred hobbies and personal interests
General office skills such as typing speed
Specific regulatory knowledge requirements such as 2 CFR 200 and sponsor-specific guidelines (Correct answer)
Preference for candidates from particular universities

Correct answer: Specific regulatory knowledge requirements such as 2 CFR 200 and sponsor-specific guidelines

Compliance specialist roles require specific regulatory knowledge, and including these requirements in the job description attracts qualified candidates and sets clear performance standards.

Question 29: A sponsor-investigator conducting a Phase I first-in-human study must ensure the investigational drug label includes:

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

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 30: A CRA professional encounters an unfamiliar situation while performing professional standards & ethics 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
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 31: What is the purpose of a 'rate agreement' negotiated with the federal government for an academic institution?

To establish the approved indirect cost (F&A) rates that can be applied to sponsored awards (Correct answer)
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 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 32: 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?

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

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 33: To prevent medication errors in clinical trials, the site SOP should specify that investigational product dispensing is performed by:

Any qualified study staff member after training
Only a licensed pharmacist or qualified designee per state law (Correct answer)
The Principal Investigator personally
A sponsor representative during site visits only

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 34: A university uses a federal grant to purchase a $6,000 laptop. Under Uniform Guidance, this item is classified as:

A minor equipment item expensed directly
An unallowable cost
Supplies (Correct answer)
Equipment requiring capitalization

Correct answer: Supplies

Under 2 CFR Part 200, supplies are defined as items with a per-unit acquisition cost below the equipment threshold, which is $5,000 unless the institution has a higher threshold — but since $6,000 exceeds the federal $5,000 threshold, it would be equipment; however if the institution's capitalization threshold is higher, it may be treated as supplies — the standard federal threshold makes this equipment.

Question 35: 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
Prepared by the site pharmacy without sponsor oversight
Manufactured and labeled to be indistinguishable from the active drug in appearance and packaging (Correct answer)

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 36: An IND-exempt study using an approved drug in a new dose combination no longer requires an IND if it meets all of the following conditions EXCEPT:

The research does not involve a route of administration that increases risk
The study involves a new patient population never studied before (Correct answer)
The study is not intended to support a labeling change
The drug is lawfully marketed in the US

Correct answer: The study involves a new patient population never studied before

Studying a new (unstudied) patient population can increase risk and may require an IND; IND exemption generally requires no significant increase in risk.

Question 37: Which tool is used to track expenses?

Google Sheets
Institutional financial system (Correct answer)
Peer-reviewed journals
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 38: How does risk management apply to daily practice in Regulatory Compliance & Licensing for Certified Research Administrator professionals?

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

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

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

Question 39: A no-cost extension (NCE) allows a grantee to:

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

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 40: When a federal award is terminated for convenience by the sponsor, the recipient is entitled to:

No reimbursement for costs incurred after notification
Only administrative costs associated with closeout
Reimbursement for allowable costs incurred up to the termination date plus settlement costs (Correct answer)
The full amount of the award regardless of expenses incurred

Correct answer: Reimbursement for allowable costs incurred up to the termination date plus settlement costs

When an award is terminated for convenience, the recipient can claim allowable costs incurred through the termination date plus reasonable costs for settling and closing out the award.

Question 41: When delegating effort reporting responsibilities to departmental staff, the research administrator MUST ensure that delegates understand which core principle?

Effort reports are optional for federal awards under $100,000
Certified effort must reasonably reflect actual work and cannot be falsified (Correct answer)
Personnel can certify effort for colleagues when they are unavailable
Effort percentages only need to match the budget, not actual time

Correct answer: Certified effort must reasonably reflect actual work and cannot be falsified

Federal regulations require that certified effort reasonably reflect actual work performed; falsification constitutes research misconduct and fraud.

Question 42: What is the primary ethical obligation of a CRA professional when a conflict of interest arises during regulatory compliance & legal framework activities?

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

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 regulatory compliance & legal framework is to disclose it to all relevant parties and, if necessary, recuse from the decision. This maintains professional integrity and stakeholder trust.

Question 43: Under the Fair Labor Standards Act (FLSA), which classification most commonly applies to sponsored research staff performing professional grant management duties?

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

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 44: 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
24 months
12 months (Correct answer)
2 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 45: Which principle from adult learning theory (andragogy) is MOST important to apply when training experienced research administrators on a policy update?

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

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 46: A research administrator notices that the sponsor's RFP explicitly prohibits indirect costs. The institution's negotiated rate is 55%. What should the administrator do?

Waive indirect costs as required by the sponsor's terms (Correct answer)
Reclassify indirect costs as direct costs
Apply the full 55% rate anyway
Negotiate a reduced rate with the cognizant agency

Correct answer: Waive indirect costs as required by the sponsor's terms

When a sponsor explicitly prohibits indirect costs, the institution must comply with those terms, though this may require internal approval per institutional policy.

Question 47: Who is responsible for financial oversight of a grant?

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

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 48: Why is timely expense reporting important?

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

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

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

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 50: What is the significance of peer review in communication & stakeholder management for CRA professionals?

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

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

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

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 Financial Management & Budgeting.

Question 52: When must an institution report an unanticipated problem involving risks to subjects or others (UPIRTSO) to OHRP?

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

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 53: A foundation RFP requires a two-page project narrative. A research administrator notices the PI's draft is three pages. What is the correct course of action?

Ask the foundation for a waiver
Edit the narrative to meet the two-page limit before submission (Correct answer)
Submit as-is and note the page overrun in a cover letter
Submit the two most important pages only

Correct answer: Edit the narrative to meet the two-page limit before submission

Failure to comply with page limits is a common reason for administrative withdrawal; the administrator must work with the PI to condense the narrative.

Question 54: Which OMB Uniform Guidance section addresses allowability of costs incurred during a period of suspension or emergency closure?

2 CFR 200.405
2 CFR 200.340
2 CFR 200.403 (Correct answer)
2 CFR 200.474

Correct answer: 2 CFR 200.403

2 CFR 200.403 outlines general criteria for cost allowability, including the necessity and reasonableness standards applied during emergencies.

Question 55: Which quality improvement method is most applicable to regulatory compliance & legal framework in Certified Research Administrator?

Making changes only when mandated by regulators
Ignoring feedback and maintaining status quo
Plan-Do-Check-Act (PDCA) continuous improvement cycle (Correct answer)
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 regulatory compliance & legal framework practices.

Question 56: Which section of an NIH research proposal describes the innovation and significance of the proposed work?

Research Strategy (Correct answer)
Facilities and Resources
Specific Aims
Human Subjects

Correct answer: Research Strategy

The Research Strategy section contains the Significance, Innovation, and Approach components evaluated by study sections.

Question 57: What ethical consideration is most relevant to professional standards & ethics in CRA practice?

Following only those rules that are convenient
Prioritizing personal advancement over professional duties
Avoiding all professional development activities
Maintaining confidentiality and acting in the best interest of stakeholders (Correct answer)

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 58: How does risk management apply to daily practice in Quality Assurance Programs 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 Quality Assurance Programs requires proactive hazard identification and preventive measures, not just reactive responses. This approach reduces incidents, improves outcomes, and protects both professionals and clients.

Question 59: Which financial statement is used to report cumulative expenditures on a federal grant to the sponsoring agency?

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

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 60: Which of the following best describes a 'management decision' in the context of a Single Audit finding?

An auditor's recommendation included in the audit report
The federal awarding agency's or pass-through entity's written determination on how a finding will be resolved (Correct answer)
A senior administrator's informal agreement to improve internal controls
A board resolution authorizing new internal audit procedures

Correct answer: The federal awarding agency's or pass-through entity's written determination on how a finding will be resolved

Under 2 CFR 200.521, a management decision is the formal written determination by the responsible federal entity on the corrective action needed to resolve an audit finding.

Question 61: When a conflict arises between standard procedures and a unique situation in Facility Operations & Maintenance, what should a CRA professional prioritize?

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

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 62: 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
Strict adherence to written procedures without exception
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 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 63: 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
Determine unilaterally whether the accommodation is warranted
Initiate the interactive process with HR and the employee to identify effective accommodations (Correct answer)

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 64: A proposal budget includes a 3% annual salary escalation for a two-year project. This practice is an example of:

Budget padding
Direct cost misclassification
Unallowable cost inflation
Standard budgeting for anticipated cost increases (Correct answer)

Correct answer: Standard budgeting for anticipated cost increases

Projecting salary escalation rates reflects expected increases and is an allowable, standard budgeting practice as long as the rate is reasonable and documented.

Question 65: When a conflict arises between standard procedures and a unique situation in Financial Management & Budgeting, 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 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 66: What documentation practice is considered essential in Financial Management & Budgeting 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
Using shorthand notes that can be expanded later if needed
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 Financial Management & Budgeting ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 67: A cost is considered 'reasonable' under Uniform Guidance if:

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

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 68: Which clause defines payment terms?

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

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: What is the primary purpose of effort reporting in federally sponsored research?

To certify that the proportion of effort charged to a grant matches the actual effort expended (Correct answer)
To report the number of publications produced per effort unit
To track overtime hours for sponsored project staff
To document hours worked for payroll purposes

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 70: University royalty-sharing policies typically distribute a portion of licensing revenues to:

The licensee company as a commercialization incentive
Exclusively to the university's general operating fund
The inventors, their departments, and the university (Correct answer)
The federal agency that sponsored the original research

Correct answer: The inventors, their departments, and the university

Most university royalty-sharing policies distribute licensing revenues among the inventors personally, the inventors' departments or labs, and the institution's central funds, incentivizing invention disclosure.

Question 71: A subject on a clinical trial self-reports taking an over-the-counter NSAID prohibited by the protocol. The CRA should ensure the site:

Asks the subject to stop but takes no further action
Documents the concomitant medication and assesses protocol deviation impact (Correct answer)
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 72: Who typically reviews a proposal before submission?

Research administration office (Correct answer)
Journal editors
The general public
Competitors

Correct answer: Research administration office

The Research Administration Office (also known as Sponsored Programs Office or Grants Office) typically reviews proposals before submission to ensure compliance with institutional policies, sponsor guidelines, and regulatory requirements. They check for accuracy in budget, administrative details, and adherence to submission instructions. This review is critical for minimizing errors and increasing the likelihood of a successful submission.

Question 73: A research administrator supervisor notices a team member is consistently overwhelmed by their caseload. What is the APPROPRIATE response before considering staffing changes?

Add more projects to the employee's caseload to build resilience
Tell the employee to manage their time better without further support
Reassign all of the overwhelmed employee's work immediately
Conduct a workload analysis to identify inefficiencies, prioritization issues, or training gaps (Correct answer)

Correct answer: Conduct a workload analysis to identify inefficiencies, prioritization issues, or training gaps

A workload analysis objectively identifies whether the issue stems from volume, process inefficiency, skill gaps, or prioritization before structural changes are made.

Question 74: A subject enrolled in a nutrition study discovers they were assigned to the control arm and did not receive the supplement they hoped for. They express disappointment but do not withdraw. Which ethical obligation must the researcher fulfill?

Unblind the subject and switch them to the active arm
Ensure the subject understands they may withdraw at any time without penalty (Correct answer)
Notify the IRB that the subject's autonomy has been compromised
Offer the supplement at no cost after the study concludes as compensation

Correct answer: Ensure the subject understands they may withdraw at any time without penalty

Researchers must continuously affirm participants' right to withdraw without penalty or loss of benefits to which they are entitled.

Question 75: Why is understanding the funding agency's goals important?

To copy past funded proposals
To choose equipment
To skip technical details
To align your proposal with their mission (Correct answer)

Correct answer: To align your proposal with their mission

Understanding a funding agency's goals and mission is critical because it allows researchers to tailor their proposal to directly address the agency's priorities. Proposals that clearly align with the funder's objectives are more likely to be viewed favorably and selected for funding. This strategic alignment demonstrates that the proposed research will contribute to the agency's overarching aims.

Question 76: How should a CRA professional handle a situation where regulatory compliance & legal framework protocols conflict with practical constraints?

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

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

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 78: 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?

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

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 79: Which standard of practice is MOST important for ensuring quality in Staff Management & Training?

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
Minimizing documentation to focus on practical work

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

Question 80: How does risk management apply to daily practice in Resident Rights & Advocacy 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 Resident Rights & Advocacy requires proactive hazard identification and preventive measures, not just reactive responses. This approach reduces incidents, improves outcomes, and protects both professionals and clients.

Question 81: Under the FFATA (Federal Funding Accountability and Transparency Act), first-tier subawards above what dollar threshold must be reported in USASpending.gov?

$10,000
$30,000
$50,000
$25,000 (Correct answer)

Correct answer: $25,000

FFATA requires reporting of first-tier subawards that equal or exceed $25,000 in federal funding.

Question 82: 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?

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

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

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

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

Keeping documentation in personal notes that are not accessible to other team members
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

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 85: 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
Funds transferred between different sponsored projects
The difference between direct and indirect costs

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 86: A contractor operating under a federal cost-reimbursement contract wants to charge costs for entertainment at a conference. Under FAR 31.205-14, these costs are:

Allowable up to 2% of total contract costs
Allowable with prior contracting officer approval
Allowable if they are reasonable and allocable
Unallowable regardless of circumstance (Correct answer)

Correct answer: Unallowable regardless of circumstance

FAR 31.205-14 classifies entertainment costs as unallowable on federal contracts with no exceptions.

Question 87: 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 update the IND application
To prepare the final clinical study report

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 88: A research administrator is reviewing an invoice for laboratory cleaning services charged to a federal grant. Under 2 CFR 200, routine janitorial services are typically:

Allowable with documentation of percentage of time spent in the grant lab
Unallowable as a direct cost because they are recovered in the F&A rate (Correct answer)
Allowable as a direct cost if the lab is used solely for the grant
Allowable only if the sponsor pre-approved the cleaning contract

Correct answer: Unallowable as a direct cost because they are recovered in the F&A rate

Routine janitorial and custodial services benefit all institutional activities and are indirect costs recovered through the F&A rate, not direct charges.

Question 89: What ethical consideration is most relevant to quality assurance & continuous improvement in CRA practice?

Avoiding all professional development activities
Maintaining confidentiality and acting in the best interest of stakeholders (Correct answer)
Prioritizing personal advancement over professional duties
Following only those rules that are convenient

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 quality assurance & continuous improvement in professional practice.

Question 90: Under the revised Common Rule (2018), which change most directly expanded protections for biospecimen donors?

Prohibition on any secondary use of identifiable biospecimens
Mandatory payment to all biospecimen donors regardless of research type
Automatic exemption of all biospecimen research from IRB review
Requirement of broad consent for future unspecified research use of stored biospecimens (Correct answer)

Correct answer: Requirement of broad consent for future unspecified research use of stored biospecimens

The 2018 Common Rule introduced broad consent as a mechanism allowing future secondary research use of stored identifiable biospecimens with appropriate protections.

Question 91: When evaluating a staff member's performance in managing subrecipient monitoring, which metric is MOST indicative of competency?

Number of subrecipient agreements executed per month
Timeliness and completeness of risk assessments and monitoring reviews (Correct answer)
Amount of funding passed through to subrecipients
Number of subrecipient site visits conducted regardless of risk level

Correct answer: Timeliness and completeness of risk assessments and monitoring reviews

Competent subrecipient monitoring is demonstrated by thorough, timely risk assessments and follow-through on monitoring activities, not volume metrics.

Question 92: What is a no-cost extension?

Replaces all objectives
Adds new staff
Extending project period without extra funds (Correct answer)
Cancels the award

Correct answer: Extending project period without extra funds

A no-cost extension (NCE) allows a principal investigator to extend the project period beyond the original end date without requesting additional funds from the sponsor. This is typically granted when more time is needed to complete the project's objectives, disseminate findings, or resolve unforeseen delays, provided there are sufficient funds remaining to cover the extended period.

Question 93: What does the term 'carryover' mean in the context of federal grant management?

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

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 94: What ethical consideration is most relevant to communication & stakeholder management in CRA practice?

Following only those rules that are convenient
Prioritizing personal advancement over professional duties
Avoiding all professional development activities
Maintaining confidentiality and acting in the best interest of stakeholders (Correct answer)

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 communication & stakeholder management in professional practice.

Question 95: When developing a project budget for a federal grant, which cost category typically requires the most detailed justification?

Personnel and fringe benefits (Correct answer)
Travel costs
Supplies
Indirect 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 96: The principle of 'respect for persons' in the Belmont Report requires researchers to:

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

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 97: A research participant who is a prisoner is considered a vulnerable population primarily because of concerns about which ethical issue?

Inability to understand complex research protocols
Compromised voluntariness due to institutional coercion (Correct answer)
Lack of legal standing to sign consent documents
Automatic disqualification from minimal-risk research

Correct answer: Compromised voluntariness due to institutional coercion

Prisoners are protected under 45 CFR 46 Subpart C because incarceration can compromise voluntary participation through institutional pressures and perceived incentives.

Question 98: Under 2 CFR Part 200 (Uniform Guidance), the period of performance for a federal award ends on the award's end date. What happens to unobligated balances at that point?

They may be used for up to 90 days post-award for closeout costs
They automatically carry over to the next budget period
They transfer to the institution's indirect cost recovery account
They must be returned to the federal agency unless a no-cost extension is approved (Correct answer)

Correct answer: They must be returned to the federal agency unless a no-cost extension is approved

Unobligated balances at the end of the period of performance must be returned unless a no-cost extension has been approved by the awarding agency.

Question 99: 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 protocol deviation subject to IRB notification only
An administrative oversight requiring a corrective action plan
Research misconduct under the category of falsification (Correct answer)
A minor compliance issue handled by departmental review

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 100: A sponsor requires a university to include a 'right of first refusal' on licensing any IP developed under a sponsored research agreement. This provision primarily benefits the:

Principal investigator
Sponsor company (Correct answer)
Federal government
University's technology transfer office

Correct answer: Sponsor company

A right of first refusal gives the sponsor the option to negotiate an exclusive license before the university can offer it to others.

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

Top-down with senior leadership dictating all plan elements
Limited to department heads and legal counsel
Delegated entirely to the safety office
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 102: 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
An indirect cost that was incorrectly charged as a direct cost
A questioned cost pending resolution through the cognizant agency
An unallowable cost that must be removed and may trigger audit findings (Correct answer)

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 103: Under a Uniform Guidance cost-sharing arrangement, which QA documentation practice is essential to demonstrate compliance?

Using unspent indirect cost recovery as the sole source of cost-share
Maintaining records that show cost-share contributions meet the same standards as direct charges (Correct answer)
Reporting cost-share only in the final financial report
Tracking cost-share in a separate general ledger account with no connection to the award

Correct answer: Maintaining records that show cost-share contributions meet the same standards as direct charges

2 CFR 200.306 requires cost-sharing contributions to be verifiable, necessary, and documented with the same rigor applied to direct costs.

Question 104: Which communication style is MOST effective when delivering corrective feedback to a staff member about a compliance error?

Private, specific, and behavior-focused feedback with clear expectations for improvement (Correct answer)
General feedback in the annual performance review only
Public correction during team meetings to set an example
Email criticism copied to the employee's department chair

Correct answer: Private, specific, and behavior-focused feedback with clear expectations for improvement

Private, specific, behavior-focused feedback preserves the employee's dignity while clearly communicating the compliance issue and expected corrective action.

Question 105: A researcher wants to conduct a clinical trial at a VA medical center. Which additional regulatory requirement applies beyond standard IRB approval?

NIH Special Emphasis Panel review
State medical board certification
VA Research and Development Committee approval (Correct answer)
FDA pre-investigational new drug application

Correct answer: VA Research and Development Committee approval

VA regulations require VA R&D Committee approval for all research conducted at VA facilities, in addition to IRB approval.

Question 106: The 'three Rs' framework in animal research (Replacement, Reduction, Refinement) is required to be considered by the IACUC under which federal law?

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)
Animal Welfare Act and its implementing USDA regulations

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 107: What is the role of a compliance officer?

Write publications
Assign journal reviewers
Manage lab meetings
Ensure ethical and legal research practices (Correct answer)

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

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

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 109: A consortium research agreement involves three universities sharing data and IP. Which governance document typically controls how IP ownership and revenue sharing are allocated?

Data Use Agreement
Memorandum of Understanding
Subaward agreement
Consortium Agreement (Correct answer)

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 110: Which of the following best describes the role of a university Technology Transfer Office (TTO)?

Evaluating invention disclosures, filing patents, and negotiating licenses to commercialize university IP (Correct answer)
Administering federal grant budgets and subcontract agreements
Managing graduate student admissions and academic programs
Overseeing human subjects research and IRB compliance

Correct answer: Evaluating invention disclosures, filing patents, and negotiating licenses to commercialize university IP

A Technology Transfer Office is responsible for evaluating the commercial potential of inventions, pursuing patent protection, and licensing intellectual property to industry partners.

Question 111: 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
$10,000 — the NSF reporting threshold
$5,000 — the current PHS significant financial interest threshold (Correct answer)
$25,000 — the FDA clinical trial 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 112: A sponsor requires a Material Transfer Agreement (MTA) before shipping biological materials to a collaborating institution. Which office typically has signature authority for MTAs?

The department chair
The institution's sponsored programs or technology transfer office (Correct answer)
The IRB chair
The principal investigator

Correct answer: The institution's sponsored programs or technology transfer office

MTAs are institutional agreements that bind the organization to transfer terms, so authorized institutional officials — not individual PIs — must sign them.

Question 113: 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:

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

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 114: How often are financial reports typically submitted?

Every day
Every 5 years
Quarterly or annually (Correct answer)
Only at project end

Correct answer: Quarterly or annually

Financial reports for sponsored projects are typically submitted to the funding agency on a regular schedule, most commonly quarterly or annually. This frequency allows the sponsor to monitor the expenditure of funds, track project progress, and ensure compliance with the award's financial terms and conditions. The exact reporting schedule is specified in the award agreement.

Question 115: 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 Centers for Medicare and Medicaid Services (CMS)
The National Science Foundation (NSF)
The Office for Human Research Protections (OHRP) (Correct answer)
The Department of Justice (DOJ)

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

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 manage laboratory safety training programs
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 117: 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)
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 Medication Management Oversight ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 118: A graduate student notices that her PI has been fabricating data points in a dataset submitted to a journal. Under institutional policy, what is the MOST appropriate first step?

Report the concern through the institution's research integrity reporting mechanism (Correct answer)
Confront the PI privately and demand correction before taking further action
Contact the journal editor directly to retract the paper
Notify the funding agency's program officer immediately

Correct answer: Report the concern through the institution's research integrity reporting mechanism

Most institutions have designated research integrity officers or anonymous reporting mechanisms, which provide the appropriate and protected channel for reporting suspected misconduct.

Question 119: 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 PI holds a federal research grant exceeding $500,000
All subjects are adults with full decision-making capacity
The study is conducted at a single site with fewer than 50 participants
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 120: When implementing communication & stakeholder management practices, what should a CRA professional prioritize first?

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

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 121: When conducting a QA desk review of a subrecipient's financial records, which document provides the most direct evidence of allowable cost allocation?

The subrecipient's organizational chart
Detailed transaction listings tied to the project budget categories (Correct answer)
The subrecipient's most recent strategic plan
A summary of the subrecipient's total annual revenue

Correct answer: Detailed transaction listings tied to the project budget categories

Detailed transaction-level records allow reviewers to verify that each cost is allocable, allowable, and properly categorized against the approved budget.

Question 122: In the context of research QA, what does 'continuous monitoring' mean?

Conducting an annual audit of all federal awards
Hiring a dedicated auditor to observe all PI activities daily
Requiring monthly sponsor approval for all expenditures
Using automated tools and ongoing reviews to detect compliance issues in real time or near real time (Correct answer)

Correct answer: Using automated tools and ongoing reviews to detect compliance issues in real time or near real time

Continuous monitoring leverages technology and periodic data analytics to provide ongoing assurance between formal audits.

Question 123: 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?

46.405 (Correct answer)
46.407
46.404
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 124: What is the significance of a letter of support?

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

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

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

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 126: Under the NIH Grants Policy Statement, what is the maximum allowable indirect cost rate on training grants (T and F series)?

8% of modified total direct costs (Correct answer)
Zero — indirect costs are not allowed
26% of total direct costs
The institution's negotiated F&A rate

Correct answer: 8% of modified total direct costs

NIH caps indirect costs on training grants at 8% of modified total direct costs, regardless of the institution's negotiated rate.

Question 127: When calculating the Modified Total Direct Costs (MTDC) base for F&A recovery, which cost is EXCLUDED?

Subcontract costs exceeding $25,000 per subcontract (Correct answer)
Faculty salaries and wages
Supplies and materials
Graduate student tuition remission over $25,000

Correct answer: Subcontract costs exceeding $25,000 per subcontract

Under 2 CFR 200.68, subcontract costs above the first $25,000 of each subcontract are excluded from the MTDC base.

Question 128: Which document specifically governs protections for children as research subjects under HHS regulations?

21 CFR Part 50 Subpart C
ICH E6 Good Clinical Practice guideline
45 CFR 46 Subpart B
45 CFR 46 Subpart D (Correct answer)

Correct answer: 45 CFR 46 Subpart D

45 CFR 46 Subpart D provides additional protections for children involved as subjects in HHS-conducted or -supported research.

Question 129: Which of the following actions by a research administrator would constitute a conflict of interest requiring disclosure?

Attending a professional conference funded by the institution
Reviewing grant proposals in a subject area where the administrator has expertise
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

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 130: A research team wants to include a subaward in their NIH proposal. Which document is NOT required from the subrecipient at the time of proposal submission?

Signed subrecipient agreement (Correct answer)
Statement of Work
Biographical sketch of key personnel
Budget and justification

Correct answer: Signed subrecipient agreement

The formal subaward agreement is executed after award; at proposal stage, only the SOW, budget, and key personnel information are required.

Question 131: Under the Export Administration Regulations (EAR), what is the 'fundamental research exclusion' as it applies to universities?

Research not involving controlled technology or foreign nationals is excluded
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)
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 132: 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?

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)
Prior approval is never required if the PI approves

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

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

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 134: A sponsored research agreement (SRA) is silent on publication rights. Under standard academic norms, what right does the university TYPICALLY retain?

The right to publish results after a reasonable review period (Correct answer)
No right to publish without sponsor approval
The right to publish only with joint authorship from the sponsor
The right to publish only non-proprietary data

Correct answer: The right to publish results after a reasonable review period

Even when an SRA is silent, universities typically assert the right to publish research results after a reasonable sponsor review period, consistent with academic freedom.

Question 135: Which document must be maintained to verify that all dispensed investigational drug quantities are accounted for at a clinical site?

Delegation of authority log
Drug accountability log (Correct answer)
Subject enrollment log
Adverse event narrative

Correct answer: Drug accountability log

The drug accountability log tracks dispensing, returns, and destruction, enabling reconciliation of all investigational product.

Question 136: 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)
Learning new software systems
Reducing the office's indirect cost rate
Understanding federal regulations for the first time

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 137: Which of the following best describes a 'carryover' in the context of sponsored program management?

Rolling over an expired no-cost extension
Carrying indirect costs forward after a rate negotiation
Using unspent funds from a prior budget period in a subsequent period (Correct answer)
Transferring costs from one project to another

Correct answer: Using unspent funds from a prior budget period in a subsequent period

Carryover refers to the use of unobligated funds remaining at the end of a budget period in a subsequent budget period, which may require prior sponsor approval.

Question 138: A researcher spills a moderate amount of a flammable solvent in the lab. What is the FIRST action they should take?

Attempt to contain the spill with absorbent material
Notify the PI immediately
Call the campus fire department
Evacuate the area and alert others (Correct answer)

Correct answer: Evacuate the area and alert others

Evacuating the area and alerting others is the first priority to prevent ignition and protect personnel from fumes.

Question 139: Which office usually handles contract negotiations?

Student affairs office
Admissions department
Grant writing center
Sponsored programs office (Correct answer)

Correct answer: Sponsored programs office

The Sponsored Programs Office (SPO), or Research Administration Office, is typically responsible for negotiating research contracts on behalf of the institution. This office has the legal expertise and institutional authority to review, negotiate, and execute agreements with funding agencies, ensuring that the terms protect the institution's interests and comply with relevant regulations. They work closely with legal counsel and principal investigators during this process.

Question 140: Under 45 CFR 46 Subpart B, which condition must be met to conduct research involving pregnant women that presents greater than minimal risk?

The research must hold out the prospect of direct benefit to the woman or fetus, or the risk must be minimized (Correct answer)
The study must be limited to the first trimester of pregnancy
A separate IRB panel of obstetricians must review the protocol
The pregnant woman's husband or partner must co-sign the consent form

Correct answer: The research must hold out the prospect of direct benefit to the woman or fetus, or the risk must be minimized

Subpart B requires that research with pregnant women presenting greater than minimal risk must offer prospect of direct benefit or meet stringent risk minimization standards.

Question 141: A research administrator discovers that a newly hired staff member misrepresented their grant management experience during hiring. What is the CORRECT course of action?

Notify HR and follow institutional policies regarding misrepresentation (Correct answer)
Provide extra training to compensate for the gap
Allow the probationary period to serve as the only consequence
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 142: A subject in a longitudinal study withdraws consent mid-study. Which action by the research team is ethically required?

Immediately destroy all data already collected from that subject
Continue using previously collected data but collect no new data from that subject (Correct answer)
Notify the sponsor and await guidance before stopping data collection
Seek IRB approval before honoring the withdrawal

Correct answer: Continue using previously collected data but collect no new data from that subject

Withdrawal of consent means no new data collection; previously collected data may generally be retained unless the consent form specified otherwise.

Question 143: 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
Digital tools for enhanced data collection, analysis, and reporting (Correct answer)
Complete elimination of human professionals
Return to exclusively paper-based systems

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 144: A research administrator is reviewing a proposal budget and finds that the PI has included $10,000 for an office computer to be used primarily for writing the grant report. This cost is most likely:

Allowable as a direct cost since it is essential to the project
Allowable if approved by the department chair
Unallowable because equipment must be leased, not purchased
Unallowable as a direct cost because it primarily serves administrative purposes (Correct answer)

Correct answer: Unallowable as a direct cost because it primarily serves administrative purposes

General-purpose equipment used primarily for administrative tasks cannot be charged as a direct cost; it must be covered by indirect (F&A) costs.

Question 145: Which federal regulation governs the export of controlled biological agents and select agents for research purposes?

Select Agent Program (42 CFR Part 73) (Correct answer)
HIPAA Privacy Rule
ITAR (International Traffic in Arms Regulations)
EAR (Export Administration 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 146: A university's QA review finds that effort reports were certified by someone other than the person with first-hand knowledge of the work performed. Which federal guidance is most directly violated?

OMB Circular A-21 indirect cost rate guidance
NSF Award and Administration Guide Chapter V
FAR Part 31 cost principles for contracts
2 CFR 200.430 standards for documenting personnel activity (Correct answer)

Correct answer: 2 CFR 200.430 standards for documenting personnel activity

2 CFR 200.430 requires that personnel activity be certified by an employee or supervisory official with first-hand knowledge of the work.

Question 147: Which of the following best describes the role of a corrective action plan (CAP) following a QA finding?

To request a waiver from the sponsoring agency for the violation
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

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 148: 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 149: Why is IRB approval important in research involving humans?

To reduce research time
To skip consent
To get more funding
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 150: What is the main distinction between a Certificate of Confidentiality and a confidentiality pledge in a consent form?

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

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 151: A university's NIH grant has a 12-month no-cost extension approved. The original end date was June 30. The new end date is:

June 30 of the same year
September 30 of the following year
December 31 of the same year
June 30 of the following year (Correct answer)

Correct answer: June 30 of the following year

A 12-month no-cost extension shifts the end date by exactly 12 months, from June 30 of the original year to June 30 of the following year.

Question 152: Which regulation protects human subjects in U.S. research?

FERPA
OSHA
HIPAA
Common Rule (Correct answer)

Correct answer: Common Rule

The Common Rule (45 CFR Part 46, Subpart A) is the foundational federal policy in the United States that outlines the ethical principles and regulatory requirements for protecting human subjects in research. It mandates institutional review board (IRB) review, informed consent, and other safeguards for federally funded research involving humans.

Question 153: How should a CRA professional handle a situation where quality assurance & continuous improvement protocols conflict with practical constraints?

Avoid addressing the conflict entirely
Document the conflict and seek guidance from appropriate authorities (Correct answer)
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 154: A community member objects that a clinical trial being conducted in their neighborhood excludes local residents from the study's benefit-sharing plan. Which ethical principle supports their concern?

Beneficence, because the PI must maximize benefits to all stakeholders equally
Respect for Persons, because exclusion violates individual autonomy
Justice, because the community bearing research risks should also share in research benefits (Correct answer)
Non-maleficence, because excluding communities causes direct harm

Correct answer: Justice, because the community bearing research risks should also share in research benefits

Justice requires that communities bearing the burdens of hosting research should have fair access to resulting benefits, a principle emphasized in community-based research ethics.

Question 155: A protocol allows a 10% dose reduction for toxicity management. A subject reduces from 100 mg to 85 mg. How should this be classified?

Unauthorized departure requiring re-consent
Allowable dose modification per protocol (Correct answer)
Major protocol deviation
Protocol violation requiring IRB waiver

Correct answer: Allowable dose modification per protocol

If the protocol explicitly permits dose reductions within a defined range, implementing a 15% reduction may exceed the allowed 10%, making it a deviation—but the question's 85 mg scenario (15% reduction) would be a deviation rather than allowable; however if it reads as within the allowed range in the protocol, it is permissible.

Question 156: Which of the following activities is specifically exempt from IACUC review under the Animal Welfare Act?

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

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 157: What documentation practice is considered essential in Quality Assurance Programs within the Certified Research Administrator field?

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

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 Quality Assurance Programs ensures accuracy, provides a contemporaneous record, and is considered the gold standard for professional accountability and legal defensibility.

Question 158: 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
Proceed while favoring the outcome that benefits the professional personally
Disclose the conflict to all relevant parties and recuse from the decision if necessary (Correct answer)
Resolve the conflict privately without informing stakeholders

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

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

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 160: 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 register intellectual property with the federal government
To certify compliance with the Davis-Bacon Act
To verify institutional tax-exempt status

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 161: Which standard of practice is MOST important for ensuring quality in Medication Management Oversight?

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

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

Question 162: What should a researcher do if misconduct is suspected?

Discuss on social media
Publish anonymously
Ignore it
Report to institutional authorities (Correct answer)

Correct answer: Report to institutional authorities

If a researcher suspects misconduct, such as fabrication, falsification, or plagiarism, the ethical and regulatory obligation is to report it promptly to the appropriate institutional authorities. Institutions have established procedures for investigating such allegations confidentially and fairly, ensuring research integrity and accountability.

Question 163: In the context of regulatory compliance & legal framework, what role does continuous professional development play for CRA practitioners?

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
It is optional and only needed for career advancement
It is required only during the first year of certification

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 164: In Certified Research Administrator, what role does professional standards & ethics play in ensuring client/stakeholder satisfaction?

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

Correct answer: It builds trust through demonstrated competence and consistency

Professional Standards & Ethics builds trust through demonstrated competence and consistency, which directly contributes to stakeholder satisfaction and confidence in the CRA professional.

Question 165: Which method of allocating indirect costs uses a base that excludes equipment, capital expenditures, and subcontract amounts exceeding $25,000?

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

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

Reduction in the need for professional certification
Complete elimination of human professionals
Return to exclusively paper-based systems
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 communication & stakeholder management, augmenting rather than replacing professional expertise.

Question 167: In Certified Research Administrator, what role does communication & stakeholder management play in ensuring client/stakeholder satisfaction?

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

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 168: 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?

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

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

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

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

It indicates when performance reviews of grant staff are due
It establishes the deadline for hiring project personnel
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 171: Under 2 CFR Part 200, the concept of 'allocability' means a cost:

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

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 172: What is the significance of peer review in professional standards & ethics for CRA professionals?

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

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 173: 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
Move the cost to the departmental account without documentation
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)

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 174: A research institution's emergency operations plan (EOP) should be reviewed and updated at minimum how often?

Every 5 years
Every 3 years
Annually (Correct answer)
Only after an actual emergency

Correct answer: Annually

Best practice and many federal guidelines recommend annual review of EOPs to incorporate lessons learned and regulatory changes.

Question 175: 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 (Correct answer)
$104,000 minus equipment exclusion
$104,000
$119,600

Correct answer: $104,000

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

Question 176: Under OSHA's Laboratory Standard (29 CFR 1910.1450), who is primarily responsible for developing a Chemical Hygiene Plan?

The principal investigator
The sponsored programs office
The institution's legal counsel
The Chemical Hygiene Officer (Correct answer)

Correct answer: The Chemical Hygiene Officer

The Chemical Hygiene Officer is designated by the employer to develop and implement the Chemical Hygiene Plan under OSHA's Laboratory Standard.

Question 177: What is the PRIMARY purpose of continuing education requirements in Financial Management & Budgeting for CRA professionals?

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

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

It is optional and only needed for career advancement
It ensures practitioners remain current with evolving standards, technologies, and best practices (Correct answer)
It is required only during the first year of certification
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 professional standards & ethics because it ensures CRA practitioners remain current with evolving standards, technologies, and best practices, maintaining competency throughout their careers.

Question 179: Which documentation practice is most important for communication & stakeholder management in the CRA field?

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

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

A Federalwide Assurance (FWA) committing the institution to follow 45 CFR Part 46 (Correct answer)
A financial guarantee provided to grant sponsors
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 181: When a clinical trial participant returns unused blister packs of study drug, the site should:

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
Redistribute them to other trial participants

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 182: 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 certify the institution's human subjects research compliance
To approve all individual expenditures above a certain threshold

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 183: Which quality assurance concept refers to evaluating whether a control is preventing errors before they occur, as opposed to detecting them after the fact?

Preventive control (Correct answer)
Detective control
Compensating control
Corrective control

Correct answer: Preventive control

Preventive controls are designed to stop errors or irregularities from occurring in the first place, such as pre-approval requirements.

Question 184: What does 'burn rate' mean in monitoring a sponsored research project?

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

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 185: The FDA's 'right of access' under 21 CFR Part 312 means that FDA inspectors may review:

Any records related to the clinical investigation, including drug accountability logs (Correct answer)
IRB meeting minutes only
Only the sponsor's IND file
Subject medical insurance records

Correct answer: Any records related to the clinical investigation, including drug accountability logs

Under 21 CFR 312.58, FDA has the authority to inspect and copy all records related to a clinical investigation, including drug accountability records.

Question 186: Which section outlines research methods?

Budget
Methodology (Correct answer)
Introduction
Summary

Correct answer: Methodology

The Methodology section of a research proposal is where the researcher details the specific methods, approaches, and techniques that will be used to conduct the study. This section explains how the research problem will be addressed, including data collection, analysis, and experimental design. It assures reviewers that the proposed research is feasible and scientifically sound.

Question 187: In Certified Research Administrator, what role does regulatory compliance & legal framework play in ensuring client/stakeholder satisfaction?

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

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 188: 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
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 189: Why include a timeline in the proposal?

It increases word count
It helps demonstrate project feasibility (Correct answer)
It avoids ethical review
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 190: What is the significance of peer review in regulatory compliance & legal framework for CRA professionals?

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

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 191: 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 192: How does continuing education relate to communication & stakeholder management for CRA certified professionals?

It ensures professionals stay current with evolving standards and best practices (Correct answer)
It is optional and rarely impacts practice quality
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 193: When a conflict arises between standard procedures and a unique situation in Emergency Preparedness & Safety, what should a CRA professional prioritize?

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

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 194: 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?

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

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

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

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

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

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

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

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 198: What is the purpose of a data use agreement?

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

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 199: In the context of quality assurance & continuous improvement, what role does continuous professional development play for CRA practitioners?

It ensures practitioners remain current with evolving standards, technologies, and best practices (Correct answer)
It is optional and only needed for career advancement
It is required only during the first year of certification
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 quality assurance & continuous improvement because it ensures CRA practitioners remain current with evolving standards, technologies, and best practices, maintaining competency throughout their careers.

Question 200: In Financial Management & Budgeting, what is the FIRST step a CRA professional should take when encountering a new case or situation?

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

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 201: What is the PRIMARY purpose of continuing education requirements in Resident Rights & Advocacy 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 Resident Rights & Advocacy ensures professionals maintain current knowledge and skills as standards, technologies, and best practices evolve in the Certified Research Administrator field.

Question 202: When a conflict arises between standard procedures and a unique situation in Quality Assurance Programs, what should a CRA professional prioritize?

Strict adherence to written procedures without exception
The most cost-effective solution available
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 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 203: 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 data safety monitoring board
The IRB
The participant's primary care physician

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 204: Under the Uniform Guidance, which entity is responsible for negotiating the F&A rate for a university?

The Office of Inspector General
The cognizant federal agency (Correct answer)
The NSF program officer
The university's internal audit department

Correct answer: The cognizant federal agency

The cognizant federal agency (e.g., DHHS or ONR for most universities) is responsible for negotiating and approving the institution's F&A cost rate.

Question 205: What is the PRIMARY purpose of continuing education requirements in Quality Assurance Programs for CRA professionals?

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

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 206: Under OMB Circular A-133 (now superseded by 2 CFR Part 200 Subpart F), the threshold for a single audit has been updated to:

$750,000 in federal expenditures per fiscal year (Correct answer)
$500,000 in federal expenditures per fiscal year
$300,000 in federal expenditures per fiscal year
$1,000,000 in federal expenditures per fiscal year

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

The 2 CFR Part 200 Subpart F raises the single audit threshold to $750,000 in federal expenditures per fiscal year, up from the former $500,000 under A-133.

Question 207: Which standard of practice is MOST important for ensuring quality in Resident Rights & Advocacy?

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

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

Question 208: In Quality Assurance Programs, what is the FIRST step a CRA professional should take when encountering a new case or situation?

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

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

In Quality Assurance Programs, 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 209: What is 'program income' in the context of federal grants?

Gross income earned by the grantee that is directly generated by or earned as a result of the federal award (Correct answer)
Interest earned on federal funds held in the institutional bank account
Revenue from technology transfer unrelated to a specific award
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 210: A university receives a federal grant for research on a dual-use research of concern (DURC) pathogen. What additional oversight is required?

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

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 211: Which ethical principle primarily justifies the requirement that research involving potential therapeutic benefit must offer a favorable risk-benefit ratio?

Respect for Persons
Justice
Autonomy
Beneficence (Correct answer)

Correct answer: Beneficence

The Belmont principle of Beneficence obligates researchers to maximize possible benefits and minimize possible harms, including assessing the overall risk-benefit ratio.

Question 212: Which of the following is a fundamental principle of professional standards & ethics as it applies to Certified Retail Analyst?

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

Correct answer: Systematic evaluation and adherence to established industry standards

A fundamental principle of professional standards & ethics 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 213: Which of the following is considered a direct cost on a sponsored research project?

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

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 214: 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 sponsor-investigator themselves (Correct answer)
The institution's research compliance office
The FDA division overseeing the application

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 215: The term 'engaged in research' under OHRP guidance means an institution is engaged when its employees or agents:

Provide laboratory facilities used by visiting researchers
Obtain data specifically for the research from living individuals through intervention or interaction (Correct answer)
House IRB records for a multi-site study
Receive any federal funding related to the research project

Correct answer: Obtain data specifically for the research from living individuals through intervention or interaction

OHRP defines engagement as occurring when an institution's employees or agents obtain data through intervention or interaction with subjects, or obtain identifiable private information for research purposes.

Question 216: Which regulatory authority must approve an Investigational New Drug (IND) application before human subjects can receive an experimental drug in the United States?

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

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 217: 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
Process it immediately since it is within 120 days
Approve it if the amounts are under $500

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

Strict adherence to written procedures without exception
The most cost-effective solution available
The preference of the client or stakeholder
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 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 219: Which competency framework is most commonly referenced for developing research administrator professional development plans?

SHRM Body of Competency and Knowledge
COSO Enterprise Risk Management Framework
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 220: A graduate student discovers that her thesis advisor published her data without her knowledge or consent, listing himself as sole author. This situation primarily raises concerns under which ethical domain?

Research misconduct (plagiarism) and authorship/attribution ethics (Correct answer)
HIPAA violations for sharing research data without IRB approval
Export control violations for disseminating unpublished data
Conflicts of interest arising from the advisor-student relationship

Correct answer: Research misconduct (plagiarism) and authorship/attribution ethics

Publishing another researcher's data without attribution or consent constitutes plagiarism and violates authorship norms, both of which fall under research misconduct and publication ethics.

Question 221: A research building fire destroys lab notebooks containing original experimental data. From a compliance perspective, what is the most critical immediate concern?

Notifying the IRB of protocol disruption
Reordering lab supplies
Reporting the data loss to relevant sponsors and assessing regulatory impact (Correct answer)
Filing an insurance claim for equipment

Correct answer: Reporting the data loss to relevant sponsors and assessing regulatory impact

Federal awards often require data retention; losing records must be reported to sponsors to assess compliance impact and determine remediation steps.

Question 222: When should a contract be fully executed?

At final billing
During data collection
Before any project work begins (Correct answer)
After results are published

Correct answer: Before any project work begins

A research contract must be fully executed, meaning signed by all authorized parties, before any project work or expenditure of funds commences. This ensures that all terms and conditions are legally binding from the outset, protecting all parties involved. Starting work without an executed contract can lead to financial risks, legal liabilities, and non-compliance with sponsor requirements.

Question 223: What is the primary purpose of communication & stakeholder management in the context of Certified Research Administrator?

To eliminate the need for ongoing training
To reduce organizational costs exclusively
To replace established industry guidelines
To ensure consistent quality and professional accountability (Correct answer)

Correct answer: To ensure consistent quality and professional accountability

Communication & Stakeholder Management in Certified Research Administrator primarily ensures consistent quality and professional accountability, forming the foundation of competent practice in this field.

Question 224: Why is intellectual property (IP) addressed in contracts?

To avoid copyright issues
To remove responsibilities
To define ownership of research outcomes (Correct answer)
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 225: Under the concept of 'cost sharing,' what is the distinction between mandatory and voluntary committed cost sharing?

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

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 226: A research institution's QA team uses data analytics to flag grant accounts with expenditure rates below 10% in the final 90 days before project end. What compliance risk does this pattern most likely signal?

Potential end-of-grant spending that may include unallowable costs rushed to liquidate balances (Correct answer)
Underperformance requiring sponsor notification of delay
Violation of budget flexibility provisions under 2 CFR 200.308
Excessive indirect cost recovery

Correct answer: Potential end-of-grant spending that may include unallowable costs rushed to liquidate balances

Low spend rates followed by rapid end-of-grant spending are a known risk indicator for potentially unallowable or improperly allocated costs.

Question 227: A subrecipient under a federal pass-through award is BEST described as:

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

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 228: 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
Filing a police report for stolen goods
Obtaining sponsor approval or following the agency's disposition requirements (Correct answer)
Notifying the IRB of the equipment loss

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 229: A laboratory's emergency action plan (EAP) must, at minimum, include which element per OSHA 29 CFR 1910.38?

Annual financial reserves for disaster recovery
Chemical inventory updated monthly
A list of all hazardous waste disposal contractors
Procedures for reporting a fire or other emergency (Correct answer)

Correct answer: Procedures for reporting a fire or other emergency

OSHA 29 CFR 1910.38 requires that EAPs include procedures for reporting emergencies such as fires as a minimum required element.

Question 230: When a research institution must dispose of radioactive waste, which federal agency's regulations primarily govern this process?

Occupational Safety and Health Administration (OSHA)
Nuclear Regulatory Commission (NRC) (Correct answer)
Department of Energy (DOE)
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 231: Which type of maintenance strategy uses sensor data and predictive analytics to schedule repairs before equipment failure occurs?

Predictive maintenance (Correct answer)
Run-to-failure maintenance
Preventive maintenance
Corrective maintenance

Correct answer: Predictive maintenance

Predictive maintenance leverages real-time monitoring and data analysis to anticipate failures and schedule maintenance proactively.

Question 232: After a major disruptive event, a research administrator should document all extraordinary costs separately primarily because:

IRB regulations mandate separate financial tracking of protocol disruptions
Documentation supports potential reimbursement, insurance claims, and audit defense (Correct answer)
OMB requires a separate cost center for every emergency
Sponsors may not allow any costs incurred during the emergency

Correct answer: Documentation supports potential reimbursement, insurance claims, and audit defense

Separate documentation of emergency costs supports reimbursement claims, insurance recovery, FEMA public assistance applications, and potential audit inquiries.

Question 233: Which approach BEST supports knowledge retention when training staff on complex federal reporting requirements?

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

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 234: An institution receives a federal grant and wishes to subcontract a significant portion of the work to a foreign university. Under 2 CFR 200, what requirement applies?

The institution must obtain prior written approval from the federal agency (Correct answer)
Foreign subcontracts are prohibited without congressional approval
Foreign subcontracts require OFAC screening only
No additional requirements apply beyond standard subrecipient monitoring

Correct answer: The institution must obtain prior written approval from the federal agency

Contracting with foreign entities typically requires prior approval from the federal awarding agency under 2 CFR 200.308.

Question 235: The SBIR (Small Business Innovation Research) program requires that small businesses receiving awards:

License any resulting patents nonexclusively to all domestic companies
Retain the principal research at U.S.-based small businesses and keep data rights (Correct answer)
Partner with a university for all Phase II activities
Transfer all IP developed under the award to the federal government

Correct answer: Retain the principal research at U.S.-based small businesses and keep data rights

SBIR policy requires that the principal research be conducted by the small business concern and that data rights are retained by the awardee, supporting commercialization by domestic small businesses.

Question 236: Which requirement under the Research Policy Handbook relates to responsible stewardship and mandates that data supporting federally funded research publications be publicly accessible?

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

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 237: 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?

Allocability under 2 CFR 200.405
Consistency under 2 CFR 200.405
Reasonableness under 2 CFR 200.404
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 238: What is the purpose of a budget justification in a federal grant proposal?

To certify that costs comply with 2 CFR 200
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 summarize the total costs requested

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 239: A research administration office wants to develop a cross-training program to reduce single-point-of-failure risk. Which area should be prioritized FIRST?

Core compliance functions such as effort reporting and award closeout (Correct answer)
Faculty recruitment and onboarding
Administrative filing and copying tasks
Social media management for the research office

Correct answer: Core compliance functions such as effort reporting and award closeout

Effort reporting and award closeout are high-risk compliance functions where staff absence can cause regulatory violations, making them the highest cross-training priority.

Question 240: Under 2 CFR 200, which of the following is a characteristic of an allowable cost?

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

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

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

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 242: In Staff Management & Training, 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
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

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

In Staff Management & Training, 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 243: What is the primary purpose of a 'shelter-in-place' order during a hazardous material release?

To keep building occupants inside to reduce exposure to outdoor contaminants (Correct answer)
To quarantine infected individuals from the general population
To secure research animals in their housing areas
To lock down computer systems against cyberattack

Correct answer: To keep building occupants inside to reduce exposure to outdoor contaminants

Shelter-in-place directives keep occupants indoors where building structure provides protection from hazardous outdoor atmospheric releases.

Question 244: 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 National Research Act of 1974
The Stevenson-Wydler Technology Innovation Act

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

Recording only outcomes while omitting the methods and processes used
Completing documentation only when requested by auditors or supervisors
Maintaining comprehensive records that include procedures, observations, results, and any anomalies (Correct answer)
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 246: A researcher wants to use a Limited Dataset (as defined under HIPAA) for research without obtaining individual authorization. What is required?

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
Certification that the dataset contains no PHI whatsoever

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 247: A researcher wants to re-contact subjects from a completed study to recruit them into a new study. What is the primary ethical concern?

Subjects cannot legally consent to more than one study
Re-contact requires FDA approval before it can occur
Re-contact is prohibited by HIPAA in all circumstances
The original consent may not have authorized future contact for new research (Correct answer)

Correct answer: The original consent may not have authorized future contact for new research

If the original consent form did not address re-contact for future studies, researchers must seek IRB guidance before reaching out to former participants.

Question 248: Under Bayh-Dole, a university's obligation to file for patent protection on a subject invention is triggered only if:

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

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 249: A senior research administrator is mentoring a junior colleague who struggles with sponsor deadline management. Which strategy is MOST effective?

Assume the junior colleague will improve without intervention
Create a shared deadline tracking system and review it weekly together (Correct answer)
Transfer all deadline-sensitive work to more experienced staff
Assign the junior colleague easier proposals only

Correct answer: Create a shared deadline tracking system and review it weekly together

A collaborative tracking system paired with regular check-ins builds the junior colleague's skills while ensuring deadlines are not missed.

Question 250: A study subject experiences an unexpected serious adverse event that the investigator believes may be related to the investigational drug. The IND sponsor's timeline to report this to the FDA as an IND Safety Report is:

At the end of the study in the final report
Within 24 hours regardless of severity
Within 7 calendar days if fatal or life-threatening; within 15 calendar days for others (Correct answer)
Within 30 days for all unexpected serious adverse events

Correct answer: Within 7 calendar days if fatal or life-threatening; within 15 calendar days for others

21 CFR 312.32 requires fatal or life-threatening unexpected serious adverse events to be reported within 7 days; other unexpected serious adverse events within 15 days.

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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