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PRF practice questions

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Question 1Research Design and Planning

A researcher wants to test whether a new tutoring program improves exam scores compared with the standard program. Which design provides the strongest evidence of a causal effect?

  1. A cross-sectional survey of students in both programs
  2. A randomized controlled trial assigning students to programs Correct answer.
  3. A case study of one classroom using the new program
  4. A single-group pretest-posttest study of the new program

Explanation

Random assignment balances known and unknown confounders across groups, so differences in outcomes can be attributed to the program itself. Designs without a comparison group or without random assignment leave open alternative explanations such as selection and maturation.

Question 2Research Design and Planning

In a study of a new blood pressure drug, participants are assigned to drug or placebo by a coin flip performed by a pharmacist. This procedure is best described as which element of research design?

  1. Blinding
  2. Matching
  3. Stratification
  4. Randomization Correct answer.

Explanation

Randomization is the process of allocating units to conditions by chance, which is exactly what a coin flip by an uninvolved party accomplishes. Blinding concerns who knows the assignment, matching pairs similar units before allocation, and stratification divides units into subgroups before randomizing.

Question 3Research Design and Planning

A researcher recruits participants by posting flyers at a fitness center to study exercise habits of the general adult population. Which threat to external validity is most direct?

  1. The sample overrepresents people who frequent fitness centers Correct answer.
  2. The measurement instrument has low test-retest reliability
  3. The study lacks a control group for comparison
  4. The sample size is too small for stable estimates

Explanation

External validity concerns whether findings generalize to the target population, and recruiting at a fitness center selects people whose exercise behavior likely differs from the general population. Reliability, comparison groups, and sample size affect precision or internal inference but not the selection bias described.

Question 4Research Design and Planning

Which statement best defines a confounding variable in an observational study?

  1. A variable that is held constant by the study design
  2. A variable that mediates the causal pathway between exposure and outcome
  3. A variable associated with both the exposure and the outcome that distorts their apparent relationship Correct answer.
  4. A variable measured with error that reduces the precision of estimates

Explanation

A confounder is a third variable that influences both the exposure and the outcome, creating a spurious association or masking a real one. Mediators lie on the causal pathway, measurement error affects precision, and controlled variables are held fixed rather than confounding.

Question 5Research Design and Planning

A researcher plans a study and writes a statement predicting that participants who sleep more will report lower stress. This statement is best called which component of the research process?

  1. A research question
  2. An operational definition
  3. A hypothesis Correct answer.
  4. A sampling frame

Explanation

A hypothesis is a testable, directional prediction about the relationship between variables, which matches the statement given. A research question is broader and interrogative, an operational definition specifies how variables are measured, and a sampling frame lists the population units.

Question 6Research Design and Planning

Which of the following is the primary purpose of obtaining informed consent before data collection?

  1. To allow researchers to publish identifiable data
  2. To ensure participants understand the study and voluntarily agree to take part Correct answer.
  3. To guarantee that participants will complete all study procedures
  4. To transfer legal liability for any harm to the participant

Explanation

Informed consent respects autonomy by ensuring prospective participants understand the purpose, procedures, risks, and their right to withdraw before agreeing. It does not compel completion, shift liability, or authorize publication of identifiable information.

Question 7Research Design and Planning

A team wants to estimate the prevalence of a chronic condition in a city at a single point in time. Which design is most appropriate?

  1. A retrospective case-control study
  2. A cross-sectional survey Correct answer.
  3. A prospective cohort study
  4. A randomized controlled trial

Explanation

Prevalence at one point in time is measured with a cross-sectional design, which samples the population and assesses status simultaneously. Cohort and trial designs follow participants forward, and case-control designs sample by outcome status, making them inefficient for prevalence estimation.

Question 8Research Design and Planning

In a study protocol, the section that specifies how many participants will be enrolled and how that number was determined is called which of the following?

  1. The sample size justification Correct answer.
  2. The informed consent form
  3. The inclusion criteria list
  4. The data analysis plan

Explanation

The sample size justification states the target enrollment and the reasoning, such as power analysis or precision requirements, behind it. The analysis plan describes statistical methods, consent forms document participant agreement, and inclusion criteria define eligibility.

Question 9Research Design and Planning

A researcher measures depression with a scale that consistently yields the same score across repeated administrations one week apart, but the scale does not actually capture depressive symptoms. Which property is demonstrated?

  1. High internal consistency but high validity
  2. High reliability but low validity Correct answer.
  3. Low reliability and low validity
  4. High validity but low reliability

Explanation

Consistency across repeated administrations indicates high test-retest reliability, while failure to measure the intended construct indicates low validity. Reliability is necessary but not sufficient for validity, so a stable instrument can still be invalid.

Question 10Research Design and Planning

A trial randomizes patients to treatment, but the outcome assessors do not know which group each patient was in. This design feature is called which of the following?

  1. Assessor blinding Correct answer.
  2. Allocation concealment
  3. Cluster randomization
  4. Intention-to-treat analysis

Explanation

Blinding of outcome assessors prevents their expectations from influencing recorded outcomes. Allocation concealment hides the upcoming assignment during enrollment, intention-to-treat concerns analysis of all randomized participants, and cluster randomization assigns groups rather than individuals.

Question 11Research Design and Planning

A researcher wants to compare two teaching methods while controlling for prior achievement. Students are first grouped into high, medium, and low prior achievement, then randomly assigned to methods within each group. This procedure is called which of the following?

  1. Stratified randomization Correct answer.
  2. Quota sampling
  3. Systematic sampling
  4. Simple randomization

Explanation

Stratified randomization divides participants into strata on a prognostic variable and then randomizes within each stratum, improving balance. Simple randomization assigns without strata, systematic sampling selects every kth unit from a list, and quota sampling is a nonprobability method.

Question 12Research Design and Planning

In a case-control study of a rare cancer, which sampling strategy is essential for efficient design?

  1. Selecting only controls who have the same cancer stage as cases
  2. Selecting controls after the exposure has been measured in cases
  3. Selecting controls from the same source population that produced the cases Correct answer.
  4. Selecting controls from a different hospital in another region

Explanation

Controls should represent the exposure distribution in the population that gave rise to the cases, so they must come from the same source population. Using a distant population or matching on outcome-related characteristics can bias the exposure comparison.

Question 13Research Design and Planning

A study reports that participants lost to follow-up differed substantially from those who remained, with dropouts being older and sicker. Which threat is most directly raised?

  1. Attrition bias Correct answer.
  2. Instrumentation drift
  3. Hawthorne effect
  4. Recall bias

Explanation

Attrition bias arises when the characteristics of participants who leave the study differ systematically from those who stay, distorting the estimated association. Recall bias concerns memory accuracy, the Hawthorne effect concerns reactivity to observation, and instrumentation drift concerns changes in measurement over time.

Question 14Research Design and Planning

A researcher plans to compare mean scores across three independent groups. Which consideration is most relevant when justifying the sample size?

  1. The alphabetical order of group labels
  2. The number of authors on the protocol
  3. The expected effect size, variability, alpha, and desired power Correct answer.
  4. The number of items in the outcome questionnaire

Explanation

Power analysis requires the anticipated effect size, the variability of the outcome, the chosen alpha level, and the target power. Questionnaire length, labeling, and authorship do not enter the statistical determination of sample size.

Question 15Research Design and Planning

A researcher wants to reduce selection bias when assigning participants to two conditions but cannot randomize for ethical reasons. Which approach is most appropriate?

  1. Assign all volunteers to the treatment and compare them with themselves over time
  2. Compare the treatment group with published norms from a different era
  3. Rely on participants to choose their own group and ignore baseline differences
  4. Use a quasi-experimental design with a comparison group and document group differences Correct answer.

Explanation

When randomization is not feasible, a quasi-experimental design with a concurrent comparison group can approximate a counterfactual, and measuring baseline covariates allows adjustment for group differences. Self-selection without adjustment or historical comparisons introduces serious bias.

Question 16Research Design and Planning

A research team wants to study whether a rare exposure is associated with a common outcome. Which design is generally most efficient for this purpose?

  1. A cohort study that follows exposed and unexposed persons Correct answer.
  2. A cross-sectional survey with no follow-up
  3. A case-control study that samples by outcome status
  4. A single-case experimental design

Explanation

When the exposure is rare, a cohort design that identifies exposed individuals and follows them forward captures enough exposed persons to study the outcome. Case-control designs are efficient for rare outcomes, not rare exposures, and cross-sectional or single-case designs cannot follow incidence well.

Question 17Research Design and Planning

A survey asks participants to report how many alcoholic drinks they consumed in the past year. Which measurement problem is most likely?

  1. Observer drift
  2. Recall bias Correct answer.
  3. Ceiling effect
  4. Demand characteristics

Explanation

Asking people to recall behavior over a long retrospective window invites recall bias, because memory is imperfect and may be influenced by current status. Observer drift involves raters changing criteria, ceiling effects involve scores clustering at the maximum, and demand characteristics involve cues about expected behavior.

Question 18Research Design and Planning

A researcher defines "physical activity" as the number of minutes per week recorded by a wrist-worn accelerometer. This definition is best described as which of the following?

  1. An operational definition Correct answer.
  2. A conceptual framework
  3. A research hypothesis
  4. A theoretical construct

Explanation

An operational definition specifies exactly how a construct will be measured, here minutes per week from an accelerometer. Conceptual frameworks and theoretical constructs describe ideas rather than measurement procedures, and a hypothesis is a testable prediction.

Question 19Research Design and Planning

In a parallel-group trial, some participants assigned to treatment never take the drug. An intention-to-treat analysis includes all randomized participants in their assigned groups. What is the main advantage of this approach?

  1. It eliminates the need for a control group
  2. It preserves the benefits of randomization and avoids bias from selective exclusion Correct answer.
  3. It guarantees that confounding is fully removed in observational data
  4. It maximizes the observed treatment effect by counting only adherers

Explanation

Intention-to-treat analysis keeps participants in their randomized groups, preserving comparability and preventing bias that arises when nonadherers are excluded. It typically yields a conservative estimate rather than maximizing the effect, and it does not replace a control group or fix observational confounding.

Question 20Research Design and Planning

A researcher wants to study how a new policy affects clinics over time, using several clinics that adopted the policy at different dates. Which design is most suitable?

  1. A single pretest measurement of all clinics
  2. A case series of one clinic's experience
  3. A cross-sectional survey of clinics after the policy
  4. A difference-in-differences design with staggered adoption Correct answer.

Explanation

Staggered adoption allows comparison of changes in adopting clinics with changes in not-yet-adopting clinics, which is the logic of difference-in-differences. A cross-sectional survey or single pretest lacks the before-and-after comparison needed to isolate policy effects.

Question 21Research Design and Planning

A study finds that participants who were observed by a researcher while completing a task performed better than those who completed it alone. Which phenomenon best explains this result?

  1. Survivorship bias
  2. The Hawthorne effect Correct answer.
  3. Regression to the mean
  4. Ecological fallacy

Explanation

The Hawthorne effect describes behavior change, often improvement, caused by awareness of being observed. Regression to the mean concerns extreme scores moving toward the average, survivorship bias concerns only successful cases remaining, and the ecological fallacy concerns inferring individual relationships from group data.

Question 22Research Design and Planning

A researcher wants to ensure that a new depression scale measures depression rather than anxiety. Which type of validity evidence is most directly relevant?

  1. Inter-rater reliability
  2. Content coverage of the item pool
  3. Discriminant validity Correct answer.
  4. Test-retest reliability

Explanation

Discriminant validity shows that a measure is not strongly related to constructs it should differ from, such as anxiety. Test-retest and inter-rater reliability concern consistency, and content coverage concerns whether items represent the intended domain rather than distinguishing it from another construct.

Question 23Research Design and Planning

In a randomized trial, the overall result is null, but a subgroup analysis of participants over 65 shows a large benefit. Which interpretation is most defensible?

  1. The overall null result should be discarded in favor of the subgroup result
  2. The subgroup finding proves the treatment works only in older adults
  3. The subgroup finding is hypothesis-generating and requires confirmation in a prespecified or independent study Correct answer.
  4. The subgroup finding demonstrates that randomization failed

Explanation

Subgroup analyses conducted after unblinding multiply comparisons and are prone to false positives, so they are best treated as hypothesis-generating unless prespecified. Confirming the effect in an independent or prespecified analysis is required before drawing firm conclusions.

Question 24Research Design and Planning

A researcher is planning a study in which participants will be followed for five years, and dropout is expected to be substantial. Which design decision best protects the study's ability to estimate the exposure-outcome association?

  1. Enrolling only participants who promise to complete all follow-up visits
  2. Restricting analysis to participants with complete data
  3. Increasing the follow-up interval to ten years
  4. Collecting baseline and time-varying covariates and planning methods that handle missing outcome data Correct answer.

Explanation

Collecting rich covariate data and prespecifying principled methods for missing data, such as multiple imputation or inverse probability weighting, reduces bias from informative dropout. Promises of completion are unreliable, complete-case analysis can bias results, and extending follow-up typically worsens attrition.

Question 25Research Design and Planning

A researcher proposes measuring a latent trait with a single item and claims the measure is valid because it correlates with a related behavior. Which critique is most fundamental?

  1. A single item cannot separate true trait variance from measurement error, so reliability and validity evidence are limited Correct answer.
  2. Correlation with a related behavior is irrelevant to validity
  3. Latent traits should never be measured in research
  4. Single items are always more valid than multi-item scales

Explanation

Single-item measures confound true score variance with random error and cannot estimate internal consistency, which limits the strength of validity claims. Convergent correlation is relevant but insufficient without evidence of reliability and discriminant validity.

Question 26Research Design and Planning

A researcher wants to test whether a new drug reduces blood pressure compared with placebo. Participants are randomly assigned to drug or placebo, and neither participants nor researchers know the assignment. Which combination of design features does this study use?

  1. Cross-sectional survey with random sampling
  2. Quasi-experimental design with single blinding
  3. Observational cohort with blinded outcome assessment
  4. Randomized controlled trial with double blinding Correct answer.

Explanation

Random assignment to conditions makes the study a randomized controlled trial, and concealing assignment from both participants and researchers constitutes double blinding. Together these features control both selection bias at allocation and expectancy effects during measurement. Observational designs lack experimental manipulation, so they cannot support the causal claim being tested here.

Question 27Research Design and Planning

A researcher is deciding whether to use a probability or non-probability sampling method for a national survey of household income. Which feature is the defining advantage of probability sampling?

  1. It eliminates the need for a sampling frame
  2. It allows estimation of sampling error and supports generalization Correct answer.
  3. It requires fewer participants than non-probability methods
  4. It guarantees that the sample mean equals the population mean

Explanation

Probability sampling gives every population member a known, nonzero chance of selection, which permits calculation of sampling error and supports inference to the population. Non-probability methods cannot quantify this error, so generalization is weaker. Probability sampling still produces sampling error and does not guarantee a perfect sample estimate.

Question 28Research Design and Planning

A researcher wants to determine whether a new screening test detects disease in the same way when administered by different nurses on the same patients. Which property of the measure is being assessed?

  1. Predictive validity
  2. Internal consistency
  3. Inter-rater reliability Correct answer.
  4. Content validity

Explanation

Inter-rater reliability concerns agreement between different observers or raters administering or scoring the same measure. Comparing nurses on the same patients directly tests consistency across raters. Internal consistency concerns item coherence, whereas validity concerns whether the instrument measures the intended construct.

Question 29Research Design and Planning

A researcher plans to compare two weight-loss programs and wants to know how many participants per group are needed to detect a meaningful difference. Which set of inputs is required for a standard sample size calculation for a two-sample comparison of means?

  1. Effect size and the number of variables only
  2. Significance level and the study duration only
  3. Effect size, significance level, power, and variability Correct answer.
  4. Population size and the number of groups only

Explanation

A standard power calculation for comparing two means requires the anticipated effect size, the alpha level, the desired power, and the standard deviation of the outcome. These four quantities jointly determine the required sample size. Omitting any of them leaves the calculation underdetermined.

Question 30Research Design and Planning

A researcher wants to examine whether a training program improves test scores, and suspects that baseline score strongly predicts the outcome. Participants are randomly assigned to training or control. Which analytic approach best increases precision by accounting for baseline score?

  1. Use analysis of covariance with baseline score as a covariate Correct answer.
  2. Drop participants with extreme baseline scores
  3. Dichotomize baseline scores and stratify the analysis
  4. Compare post-test means with an independent t-test only

Explanation

Analysis of covariance adjusts the post-test comparison for baseline score, removing variance explained by the covariate and increasing precision. Because assignment was random, this adjustment does not introduce bias and is preferred when baseline strongly predicts outcome. Simple post-test comparison ignores the covariate and loses precision.

Question 31Research Design and Planning

A researcher studying a rare occupational exposure wants to compare exposed and unexposed workers on a common disease outcome. Which design feature most directly improves efficiency for this question?

  1. Measuring the outcome before the exposure occurs
  2. Recruiting a very large cross-sectional sample at one time
  3. Matching each exposed worker to several unexposed workers on age
  4. Selecting exposed and unexposed groups and following them for the outcome Correct answer.

Explanation

When the exposure is rare, a cohort design that assembles exposed and unexposed groups and follows them for the outcome is efficient because exposure is the starting point. This ensures adequate numbers of exposed participants, which a general population sample would rarely yield. Outcome measurement before exposure would reverse the temporal order and undermine causal interpretation.

Question 32Research Design and Planning

A researcher randomizes classrooms, not individual students, to a new curriculum. Which analytic consideration is most important because of this allocation?

  1. Accounting for clustering of students within classrooms Correct answer.
  2. Analyzing only the classrooms that completed the curriculum
  3. Treating each student as an independent observation without adjustment
  4. Excluding classrooms with fewer than twenty students

Explanation

When intact groups are randomized, observations within a cluster tend to be correlated, which violates the independence assumption of standard tests. Analyses must account for clustering, for example with multilevel models or cluster-robust variance, or the false positive rate will be inflated. Ignoring the clustering understates standard errors and overstates precision.

Question 33Research Design and Planning

A researcher wants to study how a hospital's new discharge protocol changes patient outcomes over time, using a single hospital with measurements every month for two years before and after the protocol. Which threat to validity is most characteristic of this simple interrupted time series without a comparison site?

  1. Instrumentation decay from repeated testing
  2. Differential attrition between groups
  3. History effects from concurrent events occurring at the same time Correct answer.
  4. Regression to the mean from extreme baseline scores

Explanation

A single-site interrupted time series cannot separate the protocol's effect from other events occurring at the same time, such as policy changes or seasonal shifts, which is the history threat. Adding a comparison site helps rule out such concurrent explanations. Attrition and regression concern individual-level changes rather than shared temporal events.

Question 34Research Design and Planning

A researcher wants to measure patient satisfaction but worries that respondents will give socially desirable answers to a human interviewer. Which design choice most directly reduces this bias?

  1. Increasing the number of satisfaction items on the scale
  2. Shortening the recall period to one week
  3. Using a self-administered anonymous questionnaire Correct answer.
  4. Adding a trained interviewer to clarify questions

Explanation

Social desirability pressure is strongest when respondents must report sensitive attitudes face to face. A self-administered anonymous format reduces the audience effect and encourages candid responses. Adding an interviewer or more items does not remove the pressure to present oneself favorably.

Question 35Research Design and Planning

A researcher plans a case-crossover study of whether alcohol consumption triggers a cardiac event. Which design element is essential to this approach?

  1. Randomizing participants to exposure or no exposure
  2. Comparing cases with matched controls from the general population
  3. Following exposed and unexposed cohorts prospectively
  4. Using each participant as their own control across exposure windows Correct answer.

Explanation

The case-crossover design compares exposure in a hazard window just before the event with exposure in control windows for the same person, so each participant serves as their own control. This controls all stable individual confounders by design. It is suited to transient exposures and acute outcomes, not to long-term cohort follow-up.

Question 36Research Design and Planning

A researcher wants to ensure that a new quality-of-life questionnaire covers all relevant domains, including physical, emotional, and social functioning, before using it in a trial. Which activity best supports this goal?

  1. Testing whether scores predict later hospitalization
  2. Correlating the scale with an existing quality-of-life measure
  3. Computing a Cronbach alpha for the total scale
  4. Having experts and patients review the item pool for domain coverage Correct answer.

Explanation

Content validity concerns whether the items adequately represent all facets of the construct, which is established through expert and patient review of the item pool. This judgment-based process precedes empirical testing. Correlations with other measures address convergent or predictive validity, not coverage of the domain.

Question 37Research Design and Planning

A researcher wants to compare two treatments for a chronic condition but expects substantial dropout over three years. Which design strategy best preserves the validity of the randomized comparison?

  1. Excluding participants likely to move away before randomization
  2. Restricting the trial to participants who complete all follow-up visits
  3. Replacing dropouts with newly recruited participants
  4. Planning retention strategies and collecting outcome data on all randomized participants Correct answer.

Explanation

Retaining participants and measuring outcomes for everyone randomized preserves the benefits of randomization and supports intention-to-treat analysis. Restricting analysis to completers breaks the comparability created by randomization and can bias results. Replacing dropouts cannot restore the original randomized comparison.

Question 38Research Design and Planning

A researcher wants to estimate the association between a rare exposure and a common outcome while following participants over time. Which design is most appropriate?

  1. Cross-sectional survey of the general population
  2. Prospective cohort study sampling on the exposure Correct answer.
  3. Case-control study sampling on the outcome
  4. Ecological study comparing regional rates

Explanation

A prospective cohort assembles participants by exposure status and follows them for the outcome, which is efficient when the exposure is rare because exposed participants are deliberately recruited. It also establishes temporal order between exposure and outcome. Case-control designs sample on outcome and are better suited to rare outcomes.

Question 39Research Design and Planning

A trial reports a null overall effect, but a subgroup of participants with severe baseline disease shows a large benefit. The subgroup was one of twelve examined. Which interpretation is most defensible?

  1. The trial should be stopped and the treatment approved for severe disease
  2. The subgroup finding is hypothesis-generating and requires confirmation Correct answer.
  3. The subgroup finding is definitive because the effect is large
  4. The overall null result should be discarded

Explanation

When many subgroups are examined, some will show large effects by chance, so a single subgroup result is best treated as hypothesis-generating. Confirmation in a prespecified or independent analysis is needed before changing practice. A large effect size in one subgroup does not override the multiplicity problem.

Question 40Research Design and Planning

A researcher wants to minimize allocation bias in an unblinded trial comparing two surgical techniques. Which procedure best conceals the upcoming assignment from the person enrolling participants?

  1. Using sequentially numbered, opaque, sealed envelopes prepared centrally Correct answer.
  2. Assigning participants by alternating days of the week
  3. Announcing the allocation schedule at the start of the study
  4. Allowing the surgeon to choose the technique for each patient

Explanation

Central preparation of sequentially numbered, opaque, sealed envelopes prevents the enroller from predicting the next assignment, which protects allocation concealment. Predictable or transparent schemes allow the enroller to manipulate assignment, reintroducing selection bias. Concealment matters most when blinding after allocation is impossible.

Question 41Ethics, Integrity, and Regulatory Compliance

A covered entity wants to use patient information for a purpose not described in its Notice of Privacy Practices. Under the HIPAA Privacy Rule, which action is required first?

  1. Notify the Department of Health and Human Services by telephone
  2. Obtain a written authorization from each affected patient Correct answer.
  3. Post an updated notice on the entity's public website
  4. Record the new purpose in the entity's internal compliance log

Explanation

Uses and disclosures not covered by treatment, payment, operations, or another regulatory permission require a valid written authorization. The authorization must describe the purpose, the information involved, and the patient's right to revoke it. Internal documentation or website updates do not substitute for patient permission.

Question 42Ethics, Integrity, and Regulatory Compliance

A research coordinator realizes that a study subject's signed consent form was never filed. Which principle is most directly implicated?

  1. Documentation of informed consent Correct answer.
  2. Fair distribution of research benefits
  3. Equitable selection of subjects
  4. Compensation for research injury

Explanation

Informed consent must be documented in the manner approved by the reviewing body, and a missing form means the required record of consent does not exist. The other principles concern who bears burdens and benefits or how harms are remedied, not recordkeeping.

Question 43Ethics, Integrity, and Regulatory Compliance

A sponsor asks an investigator to enroll additional participants beyond the number approved by the ethics committee. What is the most appropriate response?

  1. Enroll the participants and report the change at the next annual review
  2. Ask the site pharmacist to approve the expanded enrollment
  3. Submit an amendment to the reviewing committee before enrolling more participants Correct answer.
  4. Enroll only if the sponsor provides additional funding for oversight

Explanation

Changes to an approved protocol that affect participant risk or the conduct of the study require prior review and approval. Enrolling beyond the approved number is a protocol deviation unless it is necessary to eliminate an immediate hazard. The sponsor's funding or a pharmacist's view cannot authorize the change.

Question 44Ethics, Integrity, and Regulatory Compliance

A clinical site learns that a participant experienced a serious adverse event that was unexpected and possibly related to the study drug. Which action best reflects regulatory expectations?

  1. Disclose the event only to the participant's primary care physician
  2. Wait until the study closes and summarize the event in the final report
  3. Report the event promptly to the sponsor and the reviewing ethics committee according to applicable timelines Correct answer.
  4. Publish the event in a conference abstract before notifying the sponsor

Explanation

Serious, unexpected, and possibly related events generally must be reported promptly to the sponsor and the reviewing committee so that risk to other participants can be assessed. Delayed summary reporting or public disclosure does not fulfill the safety-reporting obligation.

Question 45Ethics, Integrity, and Regulatory Compliance

An investigator holds stock options in the company sponsoring a trial and also serves as the site's principal investigator. What is the most appropriate compliance step?

  1. Resign from the trial only if a participant complains
  2. Disclose the financial interest to the institution and the reviewing committee and follow their management plan Correct answer.
  3. Transfer the stock options to a family member to remove the conflict
  4. Keep the interest private because stock ownership is not a research record

Explanation

Significant financial interests held by investigators must be disclosed and managed so that they do not compromise participant safety or data integrity. Institutions typically apply a management plan such as independent oversight or divestment. Concealment or informal transfers do not eliminate the underlying conflict.

Question 46Ethics, Integrity, and Regulatory Compliance

Which statement best describes the purpose of a Data Safety Monitoring Board in a clinical trial?

  1. It independently reviews accumulating safety and efficacy data and recommends whether the trial should continue Correct answer.
  2. It prepares the statistical analysis plan and writes the final study report
  3. It negotiates the budget and contracts with the sponsor
  4. It recruits participants and verifies their eligibility at each site

Explanation

A Data Safety Monitoring Board provides independent oversight of accumulating data, focusing on participant safety and study conduct. It may recommend continuation, modification, or termination of the trial. Operational and contractual tasks belong to the sponsor and site team.

Question 47Ethics, Integrity, and Regulatory Compliance

A study team plans to store identifiable participant data on a personal laptop without encryption. Which regulatory concern is most directly raised?

  1. Failure to obtain institutional review board approval
  2. Inadequate safeguards for protected health information Correct answer.
  3. Improper delegation of study tasks
  4. Inaccurate reporting of adverse events

Explanation

Storing identifiable data on an unencrypted personal device fails the requirement to apply reasonable administrative, technical, and physical safeguards. The concern is confidentiality and security rather than approval, delegation, or safety reporting.

Question 48Ethics, Integrity, and Regulatory Compliance

Under the Common Rule, which of the following best characterizes the role of an institutional review board?

  1. It reviews research involving human subjects to ensure that participants' rights and welfare are protected Correct answer.
  2. It licenses physicians to practice at research sites
  3. It approves the marketing claims a sponsor may make about a new drug
  4. It prosecutes researchers who commit misconduct in federally funded studies

Explanation

An institutional review board reviews and oversees human subjects research to protect participants' rights and welfare. Enforcement of misconduct and marketing approval are handled by other authorities, and licensure is a state function.

Question 49Ethics, Integrity, and Regulatory Compliance

A participant wants to withdraw from a trial after receiving an investigational product. Which response is most consistent with ethical and regulatory requirements?

  1. Require the participant to sign a waiver before leaving the study
  2. Refuse withdrawal until the participant completes the scheduled follow-up visits
  3. Withdraw the participant but delete all previously collected data
  4. Explain the consequences of withdrawal, allow the withdrawal, and clarify what follow-up data will still be collected Correct answer.

Explanation

Participation is voluntary, so a participant may withdraw at any time without penalty. The investigator should explain consequences, permit withdrawal, and clarify which data may still be used or collected as permitted by consent. Refusal, data deletion, or forced waivers undermine voluntariness.

Question 50Ethics, Integrity, and Regulatory Compliance

A monitor discovers that a site has been enrolling participants without obtaining signed consent because the consent forms ran out. What is the most accurate characterization?

  1. An acceptable practice if participants gave verbal agreement
  2. A sponsor responsibility that does not involve the site
  3. A serious deviation requiring prompt corrective action and reporting Correct answer.
  4. A minor administrative issue with no reporting obligation

Explanation

Enrolling participants without the required documented consent is a serious deviation that affects participant rights and must be reported and corrected. Verbal agreement does not satisfy documentation requirements where written consent is required. Responsibility for compliance rests with the investigator and site.