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CRA (Other exams) practice questions

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Question 1Project Development and Management

In clinical research project management, what does a project charter primarily establish at study initiation?

  1. The final budget reconciliation and closeout report
  2. The detailed statistical analysis plan for the primary endpoint
  3. The complete monitoring visit schedule and source data verification plan
  4. The formal authorization of the project and the high-level scope, objectives, and named sponsor Correct answer.

Explanation

A project charter is the document that formally authorizes a clinical study and defines its high-level scope, objectives, deliverables, and sponsor authority. Detailed statistical, monitoring, and closeout documents are developed later during planning and conduct. The charter anchors the project management baseline for the study.

Question 2Project Development and Management

A sponsor wants to track which deliverables, milestones, and team responsibilities must be completed to bring a new investigational site online. Which project management tool is most appropriate?

  1. A delegation of authority log for site staff
  2. A drug accountability dispensing record
  3. A work breakdown structure with assigned owners and milestone dates Correct answer.
  4. A serious adverse event reconciliation log

Explanation

A work breakdown structure decomposes the site activation effort into discrete work packages, each assignable to an owner with a milestone date, enabling tracking of deliverables. The other listed tools are clinical operations records used during study conduct, not planning structures for deliverables. The WBS directly supports scheduling and responsibility assignment.

Question 3Project Development and Management

During study planning, a sponsor identifies that the protocol requires a specialized laboratory test available at only two reference laboratories worldwide. This constraint is best documented and managed as which project element?

  1. A critical dependency and risk affecting site selection and timeline Correct answer.
  2. A budget variance to be reconciled at closeout
  3. A source document requiring certification
  4. A protocol deviation requiring immediate reporting to the IRB

Explanation

Limited availability of a required test creates an external dependency that constrains site selection and can delay enrollment, so it should be captured in the risk register and schedule assumptions. It is a planning constraint, not a deviation, variance, or source document issue. Documenting it early allows mitigation such as central lab agreements.

Question 4Project Development and Management

Which statement best describes the purpose of a milestone in a clinical study project schedule?

  1. A recurring meeting held with the site investigator team
  2. A zero-duration marker denoting completion of a significant deliverable or decision point Correct answer.
  3. A document that records protocol amendments over time
  4. A task that consumes the largest share of the study budget

Explanation

Milestones are zero-duration schedule markers that signal completion of an important deliverable or a decision gate, such as first patient in or database lock. They are not budget items, meetings, or records themselves. They help management track progress against key checkpoints.

Question 5Project Development and Management

A study team is using earned value management. Planned value is 200,000, earned value is 160,000, and actual cost is 180,000. What do the schedule and cost indicators suggest?

  1. Ahead of schedule and under budget
  2. Behind schedule and over budget Correct answer.
  3. Behind schedule and under budget
  4. Ahead of schedule and over budget

Explanation

Schedule variance equals earned value minus planned value (160,000 minus 200,000), a negative result indicating the project is behind schedule. Cost variance equals earned value minus actual cost (160,000 minus 180,000), also negative, indicating overspending relative to work performed. Both indicators are unfavorable.

Question 6Project Development and Management

In clinical research, what is the key distinction between a project risk and an issue?

  1. A risk is documented by the site, while an issue is documented only by the sponsor
  2. A risk requires regulatory reporting, while an issue does not
  3. A risk affects only the budget, while an issue affects only the timeline
  4. A risk is an uncertain future event, while an issue is a problem that has already occurred Correct answer.

Explanation

Risk management addresses uncertain events that may affect objectives if they occur, whereas an issue is a realized problem requiring active resolution. The distinction drives whether an entry sits in the risk register or the issue log. Both can affect any project dimension, not just budget or timeline.

Question 7Project Development and Management

A sponsor must select a contract research organization to run a large multinational trial. Which approach best supports a defensible vendor selection decision?

  1. Select the vendor that previously worked with one of the investigators
  2. Evaluate proposals against predefined weighted criteria covering capability, quality systems, and cost Correct answer.
  3. Select the vendor with the largest number of global offices
  4. Select the vendor offering the lowest total price

Explanation

A structured, criteria-based evaluation with predefined weights makes the selection transparent, comparable, and defensible to oversight bodies. Price alone, prior investigator relationships, or office count do not demonstrate the capability and quality systems needed. Documenting the criteria and scoring supports audit readiness.

Question 8Project Development and Management

Which document typically captures the agreed scope, deliverables, timelines, and payment terms between a sponsor and a service provider?

  1. The master services agreement statement of work Correct answer.
  2. The clinical study report
  3. The investigator's brochure
  4. The informed consent form

Explanation

A statement of work under the master services agreement defines the specific services, deliverables, schedule, and payment terms for the engagement. The investigator's brochure summarizes safety information, the clinical study report presents results, and the consent form informs participants. Only the statement of work governs the service relationship scope.

Question 9Project Development and Management

A project manager notices that enrollment at several sites is trending below plan midway through the study. Which action best reflects proactive project control?

  1. Wait until the next scheduled interim analysis to reassess enrollment
  2. Reduce the sample size to match current enrollment
  3. Extend the study timeline without notifying stakeholders
  4. Analyze root causes and implement corrective actions such as additional site activation or recruitment support Correct answer.

Explanation

Proactive control means comparing performance to plan, diagnosing causes, and applying corrective actions while documenting them. Waiting defers action, reducing the sample size alters the scientific design, and silent timeline changes undermine transparency. Root-cause analysis with targeted corrective actions is the appropriate management response.

Question 10Project Development and Management

In a clinical trial, which activity is the clearest example of scope creep that a project manager should challenge?

  1. Adding unplanned exploratory endpoints requested by a stakeholder without change control Correct answer.
  2. Submitting the annual report within the regulatory deadline
  3. Conducting the scheduled interim analysis per the charter
  4. Executing the approved monitoring plan at the planned frequency

Explanation

Scope creep is the uncontrolled addition of work beyond the approved baseline, such as unplanned endpoints introduced without change control. Executing approved plans, analyses, and reports are planned activities, not creep. Change control ensures additions are assessed for impact before adoption.

Question 11Project Development and Management

Which element is most important when building a study timeline for a first-in-human trial with limited safety data?

  1. Compressing all cohort starts into a single week to save time
  2. Incorporating adequate safety review and dose-escalation decision gates between cohorts Correct answer.
  3. Removing the independent safety review to reduce cost
  4. Setting the database lock date before the last cohort begins

Explanation

First-in-human trials require staged cohort progression with safety review and escalation decision gates before advancing. Compressing cohorts, locking the database prematurely, or removing safety review would compromise participant safety and scientific validity. The timeline must reflect these mandatory decision points.

Question 12Project Development and Management

A sponsor is defining roles for a study. Which description best reflects the project manager's responsibility versus the medical monitor's?

  1. The project manager adjudicates safety events, while the medical monitor manages the budget
  2. The project manager coordinates timelines, resources, and deliverables, while the medical monitor provides clinical and safety oversight Correct answer.
  3. The project manager signs the investigator's brochure, while the medical monitor drafts contracts
  4. The project manager approves protocol amendments, while the medical monitor schedules site visits

Explanation

Project management focuses on coordination of schedule, resources, and deliverables, while the medical monitor provides clinical judgment and safety oversight. Adjudicating safety events, approving protocols, and signing reference documents are medical or sponsor governance functions. Clear role definition prevents gaps and overlaps.

Question 13Project Development and Management

Which of the following best describes a critical path in a clinical study schedule?

  1. The set of activities performed by the sponsor rather than the site
  2. The longest sequence of dependent activities that determines the minimum study duration Correct answer.
  3. The activities that require regulatory submission
  4. The list of activities with the highest cost

Explanation

The critical path is the longest chain of dependent tasks through the schedule, and its length sets the shortest possible project duration. Delays on critical path activities directly delay the study finish. Cost, performer, or regulatory status do not define the critical path.

Question 14Project Development and Management

A sponsor plans to add three countries to a global trial. Which planning consideration most directly affects the project timeline and budget?

  1. The color scheme of the study branding materials
  2. The location of the sponsor's corporate headquarters
  3. Country-specific regulatory submission and approval timelines and local site start-up requirements Correct answer.
  4. The number of languages spoken by the global project manager

Explanation

Adding countries introduces country-specific regulatory approvals, ethics reviews, and local start-up requirements that directly drive schedule and cost. Manager language skills, branding, and headquarters location do not materially define the timeline. Early mapping of these requirements supports realistic planning.

Question 15Project Development and Management

Which statement correctly describes the relationship between the project plan and the risk management plan in a clinical study?

  1. The risk management plan is created only at study closeout
  2. The project plan is only relevant after all risks are closed
  3. The risk management plan replaces the project plan once approved
  4. The risk management plan defines how risks are identified, assessed, and mitigated, informing adjustments to the project plan Correct answer.

Explanation

The risk management plan establishes processes for identifying, evaluating, and responding to risks, and its outputs feed schedule and resource adjustments in the project plan. It complements rather than replaces the project plan. Risk management is continuous and begins during planning, not at closeout.

Question 16Project Development and Management

During study conduct, a key vendor announces it will discontinue a software platform used for electronic data capture. What is the most appropriate project management response?

  1. Immediately halt the study at all sites without assessment
  2. Transfer all data management responsibilities to the sites
  3. Continue using the platform without documentation until it is shut down
  4. Assess impact, develop a transition and mitigation plan, and communicate with stakeholders and regulators as needed Correct answer.

Explanation

A vendor discontinuation is a realized issue requiring impact assessment, a transition plan, and appropriate communication, including regulatory notification if validated systems change. Ignoring it risks data integrity, halting without assessment is disproportionate, and shifting responsibilities to sites is not a valid solution. Structured mitigation preserves study continuity.

Question 17Project Development and Management

Which metric is most useful for a project manager monitoring site performance during enrollment?

  1. Number of protocol pages
  2. Total number of employees at the sponsor
  3. Number of investigator meetings held globally
  4. Screening-to-randomization conversion rate by site Correct answer.

Explanation

Screening-to-randomization conversion rate shows how effectively each site turns screened candidates into enrolled participants, highlighting sites needing support. Protocol length, meeting counts, and sponsor headcount do not measure enrollment performance. Site-level conversion data enables targeted corrective action.

Question 18Project Development and Management

What is the primary purpose of a lessons-learned review at study closeout?

  1. To replace the final clinical study report
  2. To capture insights that improve planning and execution of future studies Correct answer.
  3. To assign blame for study delays
  4. To satisfy the informed consent requirement

Explanation

Lessons-learned reviews document what worked and what did not so future studies can plan and execute more effectively. They are not blame exercises, do not substitute for the clinical study report, and are unrelated to consent. Capturing these insights closes the knowledge loop for the organization.

Question 19Project Development and Management

A sponsor decides to outsource monitoring to a vendor. Which control best ensures the vendor meets agreed performance standards?

  1. Verbal assurances from the vendor's sales representative
  2. A single introductory call at contract signing
  3. Payment of the full contract value upfront
  4. Defined key performance indicators with periodic review against contractual service levels Correct answer.

Explanation

Key performance indicators tied to contractual service levels allow the sponsor to measure vendor performance objectively and address shortfalls. A single call, full upfront payment, or verbal assurances provide no ongoing oversight. Regular KPI review supports accountability and early correction.

Question 20Project Development and Management

In resource planning for a clinical study, what does a resource histogram primarily show?

  1. The randomization schedule for participants
  2. The regulatory submission history
  3. The planned or actual amount of a resource needed over time Correct answer.
  4. The list of protocol deviations by site

Explanation

A resource histogram displays resource demand over time, helping managers identify peaks and shortfalls and balance workload. Deviation lists, randomization schedules, and submission histories are unrelated data sets. Histograms support capacity planning and staffing decisions.

Question 21Project Development and Management

A protocol amendment expands eligibility criteria and adds a new endpoint. How should the project manager handle the impact on the study baseline?

  1. Delegate the assessment entirely to the site coordinators
  2. Route the change through formal change control to reassess scope, timeline, budget, and risk Correct answer.
  3. Implement the change immediately without updating plans
  4. Ignore the impact because amendments are routine

Explanation

Significant amendments change scope and therefore should pass through change control so schedule, cost, and risk impacts are assessed and approved. Immediate implementation without planning updates risks misalignment, and routine amendments still require impact review. Site coordinators lack authority for project-level assessment.

Question 22Project Development and Management

Which situation best illustrates an assumption that a project manager should validate during study planning?

  1. Documenting that the database has been validated
  2. Recording that informed consent was obtained
  3. Confirming that the protocol has been approved by the sponsor
  4. Assuming a fixed percentage of screened participants will meet eligibility criteria Correct answer.

Explanation

Assumptions are beliefs taken as true without proof, such as an expected screen failure rate, and should be validated because they drive enrollment projections. Approved protocols, validated databases, and documented consent are confirmed facts or requirements, not assumptions. Validating assumptions reduces planning risk.

Question 23Project Development and Management

Which factor most strongly justifies adding an interim analysis to a large, long-duration trial from a project management perspective?

  1. The need to increase the number of endpoints reported
  2. The desire to reduce the number of required ethics submissions
  3. The opportunity to shorten the protocol document
  4. The ability to make early decisions on futility or safety that can save time and resources Correct answer.

Explanation

Interim analyses can support early stopping for futility or safety concerns, potentially saving substantial time and resources and protecting participants. Reducing ethics submissions, shortening protocols, or adding endpoints are not valid justifications for an interim analysis. The scientific and statistical rationale must drive the decision.

Question 24Project Development and Management

Which is the best example of a leading indicator a project manager could track to anticipate enrollment shortfalls?

  1. Final enrollment total reported at study closeout
  2. Number of pre-screening inquiries and site activation status Correct answer.
  3. Total number of protocol deviations at closeout
  4. Number of participants who completed the study

Explanation

Leading indicators are early signals that predict future outcomes, such as pre-screening inquiries and site activation status, which can forecast enrollment trends. Final enrollment totals, completion counts, and closeout deviation totals are lagging indicators. Acting on leading indicators enables earlier intervention.

Question 25Project Development and Management

In clinical project management, what is the main benefit of maintaining a decision log throughout a study?

  1. It records key decisions, rationale, and owners to support accountability and continuity Correct answer.
  2. It serves as the official regulatory submission
  3. It replaces the need for a risk register
  4. It documents participant consent

Explanation

A decision log captures what was decided, why, by whom, and when, providing an audit trail and continuity when team members change. It complements the risk register rather than replacing it, and it is not a regulatory submission or consent record. This supports governance and transparency.

Question 26Project Development and Management

A study team is building a work breakdown structure (WBS) for a Phase II oncology trial. Which characteristic should the lowest-level WBS elements have so the schedule and budget can be estimated reliably?

  1. They are defined as deliverables that can be estimated and assigned to a single accountable owner Correct answer.
  2. They are detailed enough to list every individual patient visit activity across all sites
  3. They are left open-ended so the team can add activities as the study progresses
  4. They are organized by the sponsor's departmental cost centers rather than by study deliverables

Explanation

A work breakdown structure decomposes study scope into deliverable-oriented components, and the lowest level (work packages) should be estimable, assignable, and measurable so cost and duration can be forecast. Organizing by deliverables rather than by department keeps the WBS focused on what the study must produce.

Question 27Project Development and Management

A project manager is sequencing activities for a trial startup. Which relationship describes a finish-to-start dependency between site contract execution and first patient screened?

  1. The contract must be executed before screening can begin at that site Correct answer.
  2. Contract execution and screening must always occur on the same calendar day
  3. Screening completion triggers the start of contract negotiation
  4. Screening may begin before the contract is executed if the investigator agrees verbally

Explanation

A finish-to-start dependency means the predecessor activity must finish before the successor can start; here contract execution precedes first screening. This is the standard logical relationship used when building a network diagram and identifying the critical path.

Question 28Project Development and Management

A sponsor wants to compress a trial timeline by overlapping database lock with the final statistical analysis plan (SAP) finalization. Which scheduling technique is being applied?

  1. Resource leveling to smooth the analyst workload across the study
  2. Crashing by adding statistical resources to the analysis team
  3. Fast tracking through parallel execution of activities normally performed in sequence Correct answer.
  4. Scope reduction to remove non-essential endpoints from the analysis

Explanation

Fast tracking shortens duration by performing activities in parallel that would normally be sequential, accepting added risk of rework. Crashing instead adds resources to shorten duration, which is a different technique. Overlapping lock and SAP finalization is a classic fast-tracking trade-off.

Question 29Project Development and Management

A project manager needs to estimate the cost of a first-in-human study where little historical data exists and the protocol is still evolving. Which estimating approach is most appropriate?

  1. Definitive bottom-up estimating locked at the start of planning
  2. Reserve analysis applied instead of any base cost estimate
  3. Analogous estimating based on a similar prior study, refined as details become available Correct answer.
  4. Parametric estimating using a fixed cost per patient across all study types

Explanation

When detail is limited, analogous estimating uses historical similarity to produce a rough order-of-magnitude figure that can be progressively refined through rolling-wave planning. Locking a definitive estimate before the protocol stabilizes would create false precision.

Question 30Project Development and Management

A sponsor has approved a trial budget with a management reserve. What distinguishes the management reserve from the contingency reserve in clinical study budgeting?

  1. Management reserve is held by the project manager for known risks, while contingency is held by the sponsor for unknown risks
  2. Management reserve and contingency reserve are interchangeable terms for the same budget pool
  3. Management reserve covers unidentified in-scope risks and is controlled by senior management, while contingency covers identified risks Correct answer.
  4. Contingency reserve is released only at study closeout, while management reserve is spent during startup

Explanation

Contingency reserve is allocated for identified risks with accepted response plans, whereas management reserve addresses unidentified risks and is typically controlled above the project manager. Both are part of the overall budget but differ in ownership and purpose.

Question 31Project Development and Management

During a Phase III trial, the sponsor's steering committee asks the project manager to forecast the cost impact of extending enrollment by six months. Which approach best supports this forecast?

  1. Report only the total budget spent to date without projecting future spend
  2. Apply the original per-patient cost without adjusting for extended site activation overhead
  3. Defer the forecast until study closeout when actual costs are known
  4. Estimate the incremental site, monitoring, and vendor costs for the extension and compare against remaining budget Correct answer.

Explanation

Forecasting requires projecting incremental costs driven by the change, such as extended site maintenance, additional monitoring visits, and vendor time, then comparing to the remaining budget to identify a variance. Historical spend alone does not answer the forward-looking question.

Question 32Project Development and Management

A project manager is building a resource histogram for the monitoring team across the study period. What does the histogram primarily communicate?

  1. The number of monitoring full-time equivalents required in each period against available capacity Correct answer.
  2. The cost per monitoring visit by country
  3. The number of protocol deviations observed per monitoring visit
  4. The sequence of monitoring visits on the critical path

Explanation

A resource histogram displays resource demand over time, letting the project manager compare required monitoring FTE against available capacity and identify peaks or gaps. It supports decisions such as hiring, leveling, or outsourcing.

Question 33Project Development and Management

A project manager is negotiating a contract with a central laboratory. Which contract type places the greatest cost risk on the sponsor if the number of samples is uncertain?

  1. Purchase order at a fixed unit price
  2. Time-and-materials contract Correct answer.
  3. Firm-fixed-price contract
  4. Fixed-price incentive fee contract

Explanation

Time-and-materials contracts pay for actual labor hours and materials, so cost grows with the volume of work and the sponsor bears the risk when quantities are uncertain. Fixed-price arrangements shift more cost risk to the vendor.

Question 34Project Development and Management

A project manager is planning quality control for a large trial. Which activity is a preventive quality assurance step rather than a quality control inspection?

  1. Reconciling the final database against source documents
  2. Querying inconsistent laboratory values after data transfer
  3. Auditing site processes against the protocol and ICH GCP before enrollment begins Correct answer.
  4. Reviewing completed case report forms for data entry errors

Explanation

Quality assurance is process-oriented and preventive, such as auditing site readiness before enrollment to avoid errors. Quality control is product-oriented and detects defects in completed outputs, such as data review and reconciliation.

Question 35Project Development and Management

A sponsor is preparing a communication plan for a global trial with sites in multiple time zones. Which element most directly determines the escalation path when a serious safety signal arises?

  1. A defined communication matrix specifying who is notified, in what timeframe, and through which channel Correct answer.
  2. A monthly newsletter summarizing enrollment progress
  3. A distribution list of all study personnel without role definitions
  4. A shared calendar listing all scheduled team meetings

Explanation

A communication matrix assigns responsibilities, recipients, channels, and timeframes for each message type, which is what makes escalation reliable and timely. Safety signals require predefined urgency and routing, not general distribution.

Question 36Project Development and Management

Midway through a trial, the sponsor replaces the electronic data capture vendor. Which action should the project manager take first to protect study continuity?

  1. Immediately terminate all site data entry until the new system is live
  2. Approve the change without analysis to avoid delaying the vendor transition
  3. Assess the impact on the schedule, data integrity, and validation status, then update the integrated project plan Correct answer.
  4. Delegate the transition entirely to the vendor without sponsor oversight

Explanation

A vendor change is a significant change event, so the project manager should perform an integrated impact assessment covering schedule, cost, data integrity, and regulatory validation, then update the baseline plan through change control. Acting before assessment risks avoidable disruption.

Question 37Project Development and Management

A project manager wants to track earned value on a clinical study. The schedule performance index (SPI) is calculated as earned value divided by planned value. An SPI of 0.85 indicates which condition?

  1. The study is under budget relative to the work completed
  2. The study is progressing more slowly than planned for the work performed Correct answer.
  3. The study has completed more work than planned at this point
  4. The study's cost variance is negative by 15 percent

Explanation

SPI compares earned value to planned value; a value below 1.0 means less work has been accomplished than scheduled, indicating a schedule delay. Cost performance is measured separately by CPI, so SPI alone says nothing about budget.

Question 38Project Development and Management

A project manager is closing out a study and archiving records. Which action best supports the sponsor's obligation to retain essential documents for the required period?

  1. Destroy draft documents immediately after database lock
  2. Allow individual sites to store documents wherever convenient
  3. Rely on the vendor to retain records without a written agreement
  4. Transfer essential documents to a controlled archive with an index and documented retention period Correct answer.

Explanation

Essential documents must be retained in a controlled archive with a retrievable index and a defined retention period so they can be produced on request for inspection. Uncontrolled storage or undocumented vendor retention undermines that obligation.

Question 39Project Development and Management

A project manager is analyzing the critical path of a study schedule and finds two paths with nearly identical total durations. What is the most important implication for schedule risk management?

  1. Near-critical paths can be ignored because they have positive float
  2. The schedule has near-critical paths that can become critical with small delays, so they warrant close monitoring Correct answer.
  3. Only the single longest path needs monitoring because float on other paths is irrelevant
  4. The critical path is fixed and cannot change once the baseline is approved

Explanation

Near-critical paths have little total float, so small delays can shift the critical path and extend the project finish. Monitoring them alongside the critical path improves schedule risk management and supports proactive corrective action.

Question 40Project Development and Management

A sponsor is deciding whether to conduct a trial in-house or outsource to a contract research organization. Which factor is a strategic rather than purely operational consideration in that decision?

  1. The per-patient cost quoted by each vendor
  2. The turnaround time for data queries at each site
  3. The number of monitoring visits required per site
  4. Whether the capability is core to the sponsor's long-term competitive position Correct answer.

Explanation

Make-or-buy decisions weigh strategic factors such as whether a capability is core to the organization's competitive advantage, alongside operational factors like cost and turnaround time. Core capabilities are often retained in-house even when outsourcing is cheaper.

Question 41Pre-Award Research Administration

Under the federal cost principles, which type of cost is generally allowable on a sponsored project only if it is reasonable, allocable, consistently treated, and documented in the approved budget or prior approval?

  1. Alcoholic beverages served at project meetings
  2. Costs of lobbying for additional federal funding
  3. Direct costs such as project-specific laboratory supplies Correct answer.
  4. Entertainment costs for hosting sponsors

Explanation

Allowable costs must be reasonable, allocable, consistently treated, and conform to limits or exclusions in the cost principles, award terms, and approved budget. Routine project-specific supplies meet these tests when charged directly and documented. Entertainment, alcohol, and lobbying are expressly unallowable under the federal cost principles.

Question 42Pre-Award Research Administration

A principal investigator wants to begin charging a senior researcher's salary to a new award that has been selected for funding but whose notice of award has not yet been received. What is the most appropriate pre-award action?

  1. Begin charging immediately because selection for funding guarantees an award
  2. Obtain documented sponsor approval for a pre-award cost or use an approved advance account Correct answer.
  3. Split the salary across three unrelated active awards to avoid detection
  4. Charge the salary retroactively to the prior award with the largest remaining balance

Explanation

Costs incurred before the award start date require sponsor approval or an internally approved pre-award spending mechanism, because the award is not yet in force. Selection for funding alone does not authorize charging. Retroactive or arbitrary allocation to other awards is improper cost transfer practice.

Question 43Pre-Award Research Administration

Which document typically provides the sponsor's binding requirements that govern a funded project once an award is issued?

  1. The institution's internal routing form
  2. The notice of award and its incorporated terms and conditions Correct answer.
  3. The project's prior-year financial statement
  4. The investigator's curriculum vitae

Explanation

The notice of award, together with the terms and conditions it incorporates, establishes the sponsor's binding requirements for the project. Internal routing forms are administrative tools and do not bind the sponsor. A CV and financial statements do not carry award terms.

Question 44Pre-Award Research Administration

A funding opportunity announcement states that applications must be submitted through a specific electronic system by 5:00 p.m. sponsor local time on the deadline date. Which pre-award practice best manages this requirement?

  1. Submit at the last hour and rely on the system's grace period
  2. Email the full application to the program officer as a backup
  3. Rely on the institutional deadline being later than the sponsor deadline
  4. Complete internal review and submission well before the sponsor deadline Correct answer.

Explanation

Sponsor systems commonly reject late submissions without exception, and grace periods are not guaranteed. Building internal deadlines that precede the sponsor cutoff protects against system congestion and errors. Email backups are generally not accepted unless the announcement expressly permits them.

Question 45Pre-Award Research Administration

Which element of a proposal budget represents costs that cannot be readily assigned to a specific project and are instead distributed through a negotiated rate?

  1. Indirect costs Correct answer.
  2. Cost-sharing commitments
  3. Participant support costs
  4. Equipment costs

Explanation

Indirect costs, also called facilities and administrative costs, cover shared costs that cannot be readily identified with a single project and are applied through a negotiated rate. Participant support, equipment, and cost sharing are direct cost categories.

Question 46Pre-Award Research Administration

An investigator plans to include a subaward to a collaborating university in a proposal. What documentation should the pre-award office typically collect from the subrecipient before submission?

  1. A subrecipient commitment letter, scope of work, and detailed budget Correct answer.
  2. A copy of the subrecipient's audited financial statements from the past decade
  3. A signed patent assignment from each subrecipient employee
  4. Verbal confirmation of the collaboration from the subrecipient's dean

Explanation

Sponsors and institutions expect documented subrecipient commitment, including a defined scope of work, a detailed budget and justification, and institutional endorsement. This supports the prime budget and the risk assessment process. Patent assignments, lengthy audit histories, and verbal confirmations are not standard submission requirements.

Question 47Pre-Award Research Administration

Which statement best describes the purpose of a facilities and administrative rate agreement negotiated with a federal cognizant agency?

  1. It authorizes the institution to begin spending before an award
  2. It guarantees the sponsor will pay all proposed costs
  3. It replaces the need for a project budget
  4. It sets the negotiated indirect cost rates that may be applied to sponsored agreements Correct answer.

Explanation

A negotiated rate agreement establishes the indirect cost rates and the bases to which they apply for a defined period. It does not guarantee funding, eliminate budgeting, or authorize pre-award spending. Those matters are governed by the award and institutional policy.

Question 48Pre-Award Research Administration

A sponsor limits indirect costs to 8 percent of total direct costs, while the institution's negotiated rate is 55 percent of modified total direct costs. How should the pre-award office handle this in the proposal budget?

  1. Apply the full negotiated rate and note the sponsor limit as an error
  2. Apply the negotiated rate to a hidden line item labeled supplies
  3. Apply the sponsor's 8 percent limit and document the resulting unrecovered amount Correct answer.
  4. Omit indirect costs entirely from the budget

Explanation

When a sponsor publishes a lower indirect cost rate, that limit governs the award, and the institution applies the sponsor rate while documenting any unrecovered facilities and administrative costs. Charging the full negotiated rate against a stated sponsor limit would violate the announcement. Concealing costs in a direct line item is improper.

Question 49Pre-Award Research Administration

Which situation most clearly requires prior sponsor approval before the cost can be charged to a federal award?

  1. Transferring funds among budget categories when the award permits rebudgeting without approval
  2. Purchasing routine office supplies within the approved budget
  3. Paying a graduate student the rate stated in the approved budget
  4. Changing the project's specific aims to add a new line of research Correct answer.

Explanation

A change in scope or specific aims generally requires prior sponsor approval because it alters the approved project. Routine budgeted purchases, budgeted salaries, and rebudgeting expressly allowed by the award do not. The award terms define which prior-approval categories apply.

Question 50Pre-Award Research Administration

Which of the following is a characteristic of a fixed-price agreement rather than a cost-reimbursement agreement?

  1. Payment is based on a predetermined amount for a defined deliverable or scope Correct answer.
  2. The award requires submission of detailed expenditure reports for reimbursement
  3. Allowable costs incurred determine the total amount paid
  4. The sponsor reimburses all reasonable costs up to a ceiling

Explanation

A fixed-price agreement pays a set amount for defined deliverables or scope, shifting cost-overrun risk to the recipient. Cost-reimbursement awards pay allowable incurred costs up to a ceiling and require expenditure reporting. The two mechanisms differ in how payment and risk are structured.