Mixed Deck — All CRA Topics Flashcards

Under 45 CFR Part 46, which category of research qualifies for exemption from full IRB review when involving educational tests, surveys, or interviews with adults?

Answer: Research involving only benign behavioral interventions with no identifiable data

Exemption Category 3 covers benign behavioral interventions with no reasonably anticipated risks, where data is not identifiable or disclosure would not harm subjects.

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

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

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

Under 21 CFR Part 312, which of the following is NOT an investigator obligation related to investigational drugs?

Answer: Manufacturing the drug at the clinical site

Investigators are not responsible for manufacturing investigational drugs; that obligation falls on the sponsor under GMP requirements.

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?

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.

Why include a timeline in the proposal?

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.

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

Answer: File a patent application within 12 months of disclosure

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

In Staff Management & Training, what is the FIRST step a CRA professional should take when encountering a new case or situation?

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.

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

Answer: Financial reporting and award compliance deadlines

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

Which term describes a formal assessment of a building's systems and structure to identify deficiencies and estimate repair or replacement costs?

Answer: Facility condition assessment (FCA)

A Facility Condition Assessment (FCA) systematically evaluates building components and produces a Facility Condition Index (FCI) to prioritize repairs.

What does the acronym 'ICS' stand for in emergency management?

Answer: Incident Command System

The Incident Command System (ICS) is a standardized on-scene emergency management framework used by FEMA and adopted widely by institutions.

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

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

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

What is the primary purpose of the Specific Aims page in an NIH R01 application?

Answer: To concisely state the goals, objectives, and impact of the proposed research

The Specific Aims page is a one-page summary of research goals, hypotheses, and expected outcomes that often determines whether reviewers read the full application favorably.

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

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.

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

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.

When should a contract be fully executed?

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.

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

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.

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

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.

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

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.

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?

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.

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

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.