Certified Research Specialist (CRS) — Questions and Answers

Question 1: When reporting on a sensitive topic such as mental health or addiction, researchers should:

Use person-first, non-stigmatizing language and consider participant welfare in all reporting decisions (Correct answer)
Focus only on negative outcomes to highlight the seriousness
Use stigmatizing language to emphasize severity
Avoid publishing to prevent potential harm

Correct answer: Use person-first, non-stigmatizing language and consider participant welfare in all reporting decisions

Person-first, non-stigmatizing language respects participant dignity and reduces the risk that reporting contributes to social harm or discrimination.

Question 2: What is the importance of descriptive statistics?

Summarize and describe data (Correct answer)
Collect data
Test hypotheses
Predict future events

Correct answer: Summarize and describe data

Descriptive statistics are fundamental for summarizing and describing the main features of a dataset. They provide simple summaries about the sample and the measures, such as means, medians, modes, and standard deviations. This allows researchers to understand the basic characteristics and distribution of their data, forming the foundation for further, more complex analyses.

Question 3: The Belmont Report established which three core ethical principles for human subjects research?

Safety, efficacy, and consent
Justice, transparency, and autonomy
Privacy, equity, and fairness
Respect for persons, beneficence, and justice (Correct answer)

Correct answer: Respect for persons, beneficence, and justice

The 1979 Belmont Report identified respect for persons, beneficence, and justice as the foundational ethical principles governing human subjects research.

Question 4: Which test is most appropriate when comparing the median scores of the same participants under three different conditions?

Wilcoxon Signed-Rank Test
Kruskal-Wallis Test
One-Way ANOVA
Friedman Test (Correct answer)

Correct answer: Friedman Test

The Friedman test is the non-parametric equivalent of the one-way repeated-measures ANOVA, used when the same subjects are measured under three or more conditions.

Question 5: What does 'retraction' of a published article indicate?

The article has been formally withdrawn due to serious errors or misconduct (Correct answer)
The authors have requested a title change after publication
The article has been updated with additional data
The article is being moved to a different journal section

Correct answer: The article has been formally withdrawn due to serious errors or misconduct

Retraction is the formal removal of a published article from the scientific record, typically due to data fabrication, plagiarism, duplicate publication, or critical errors.

Question 6: Which qualitative tradition is most appropriate for studying how a small, bounded social unit functions as a whole?

Case study (Correct answer)
Phenomenology
Grounded theory
Discourse analysis

Correct answer: Case study

Case study research is designed to provide an in-depth understanding of a bounded system — such as an organization, community, or program — in its real-world context.

Question 7: Which metric measures the number of times an article has been downloaded or viewed, regardless of citations?

Impact factor
H-index
Altmetrics / usage statistics (Correct answer)
Eigenfactor score

Correct answer: Altmetrics / usage statistics

Altmetrics and usage statistics (downloads, views, social media mentions) capture attention and reach beyond traditional citation counts, reflecting immediate community interest.

Question 8: What distinguishes a focus group from individual in-depth interviews?

Focus groups use structured questionnaires while interviews are unstructured
Focus groups leverage group dynamics and interaction to generate data (Correct answer)
Focus groups analyze secondary data while interviews collect primary data
Focus groups are always conducted online while interviews are face-to-face

Correct answer: Focus groups leverage group dynamics and interaction to generate data

The defining feature of focus groups is the deliberate use of group interaction and discussion to produce insights that would not emerge from individual interviews.

Question 9: What action should an author take upon discovering a significant error in their published paper?

Wait to see if peer reviewers of future papers notice the error
Post a note only on the author's personal website
Contact the journal editor to issue a formal correction or erratum (Correct answer)
Submit a new paper correcting the finding without referencing the original

Correct answer: Contact the journal editor to issue a formal correction or erratum

Authors are ethically obligated to notify the journal editor promptly so a correction (erratum) can be published and linked to the original article.

Question 10: Which of the following is an example of 'evidence mapping' in a literature review?

Creating a visual or tabular overview of available evidence across multiple dimensions (Correct answer)
Conducting interviews with study authors
Extracting p-values from each included study
Performing a sensitivity analysis on pooled data

Correct answer: Creating a visual or tabular overview of available evidence across multiple dimensions

Evidence mapping systematically charts what is known across a topic area, identifying where evidence is strong, weak, or absent.

Question 11: Which element is NOT required to be included in informed consent documents according to 45 CFR 46.116?

The expected duration of participation
A description of foreseeable risks
The researcher's home address (Correct answer)
A statement that participation is voluntary

Correct answer: The researcher's home address

The researcher's home address is not a required element of informed consent; required elements include risks, benefits, voluntariness, and contact information for questions.

Question 12: Which federal body issued the overarching policy definition of research misconduct that applies across all federally funded research in the US?

Office of Research Integrity (ORI)
National Science Foundation (NSF)
Office of Science and Technology Policy (OSTP) (Correct answer)
National Institutes of Health (NIH)

Correct answer: Office of Science and Technology Policy (OSTP)

OSTP issued the Federal Policy on Research Misconduct in 2000, establishing the government-wide FFP definition of research misconduct that all federal agencies must adopt.

Question 13: The standard error of the mean (SEM) decreases as:

Sample size increases (Correct answer)
Sample variance increases
The population mean increases
Sample size decreases

Correct answer: Sample size increases

SEM = σ/√n, so increasing sample size reduces the SEM, making the sample mean a more precise estimate of the population mean.

Question 14: What is the role of a Sponsor in a clinical trial as defined by federal regulations?

To treat enrolled patients
To take responsibility for initiating, managing, and financing the trial (Correct answer)
To publish final results
To conduct IRB reviews

Correct answer: To take responsibility for initiating, managing, and financing the trial

The Sponsor is the entity that initiates, manages, and bears overall responsibility for the design, conduct, and regulatory compliance of a clinical trial.

Question 15: When a researcher first suspects research misconduct by a colleague, what is the appropriate initial step?

Report the concern to the institution's research integrity officer or ombudsman (Correct answer)
Confront the suspected researcher directly and demand an explanation
Post an anonymous notice on a public academic forum
Immediately notify the journal editor where the work was published

Correct answer: Report the concern to the institution's research integrity officer or ombudsman

Suspected misconduct should be reported to the institution's designated research integrity officer, who is trained to handle such matters confidentially and per federal procedures.

Question 16: Ghost authorship refers to a situation where:

A person who made significant intellectual contributions is not listed as an author (Correct answer)
An author requests anonymity during the peer review process
An author passes away before a paper is published
A corresponding author submits a manuscript under a pseudonym

Correct answer: A person who made significant intellectual contributions is not listed as an author

Ghost authorship occurs when someone who made substantial contributions to a study is excluded from the author list, often to conceal industry involvement or conflicts of interest.

Question 17: What is the role of a 'PICO' framework in structuring a literature review search?

It organizes the research question into Population, Intervention, Comparison, and Outcome (Correct answer)
It identifies conflicts of interest among study authors
It determines the sample size needed for significance
It classifies studies by their level of evidence

Correct answer: It organizes the research question into Population, Intervention, Comparison, and Outcome

PICO structures the research question to ensure search terms cover all key dimensions: who is studied, what is done, what it is compared to, and what is measured.

Question 18: Which document outlines the objectives, design, methodology, and statistical considerations of a clinical trial?

Informed Consent Form
Study Protocol (Correct answer)
Case Report Form
Investigator Brochure

Correct answer: Study Protocol

The study protocol is the master document that describes the scientific rationale, objectives, and procedures for conducting a clinical trial.

Question 19: Which sampling method ensures every member of the population has an equal chance of being selected?

Purposive sampling
Quota sampling
Snowball sampling
Simple random sampling (Correct answer)

Correct answer: Simple random sampling

Simple random sampling gives every population member an equal probability of selection, minimizing selection bias.

Question 20: Phase I clinical trials primarily assess which of the following?

Efficacy in large populations
Cost-effectiveness
Safety, tolerability, and dosage (Correct answer)
Long-term side effects

Correct answer: Safety, tolerability, and dosage

Phase I trials focus on evaluating the safety, tolerability, and appropriate dosing of a new intervention in a small group of participants.

Question 21: P-hacking (also called data dredging) in research refers to:

Conducting multiple analyses or trying different statistical approaches until a significant result is found (Correct answer)
Falsifying p-values in the final statistical report submitted to a journal
Unauthorized access to a competitor's research database
Reporting only non-significant results to counteract publication bias

Correct answer: Conducting multiple analyses or trying different statistical approaches until a significant result is found

P-hacking involves conducting numerous analyses or manipulating approaches until a p-value below the threshold is achieved, inflating the false-positive rate and undermining reproducibility.

Question 22: Which of the following best describes a key competency required for qualitative research approaches in CRS practice?

Strong analytical skills combined with effective communication and ethical judgment (Correct answer)
The ability to work independently without any oversight
Reliance on a single methodology for all situations
Memorization of all relevant regulations without understanding context

Correct answer: Strong analytical skills combined with effective communication and ethical judgment

CRS professionals working in qualitative research approaches need analytical skills to assess situations, communication skills to convey findings, and ethical judgment to make sound decisions.

Question 23: In hypothesis testing, a Type II error occurs when a researcher:

Misclassifies interval data as nominal
Accepts a false null hypothesis (Correct answer)
Rejects a true null hypothesis
Uses too large a sample

Correct answer: Accepts a false null hypothesis

A Type II error (false negative) occurs when the null hypothesis is not rejected even though it is actually false.

Question 24: Under GCP guidelines, which party is responsible for verifying that a clinical investigator is qualified to conduct a trial?

Sponsor (Correct answer)
IRB
DSMB
FDA

Correct answer: Sponsor

The Sponsor is responsible for selecting qualified investigators and confirming their training, resources, and credentials before a trial begins.

Question 25: A predatory journal is best described as a publication that:

Exploits the open-access model by charging fees without providing legitimate peer review or editorial services (Correct answer)
Charges authors submission fees higher than those of reputable journals
Requires authors to suggest their own peer reviewers
Only publishes studies with positive or statistically significant results

Correct answer: Exploits the open-access model by charging fees without providing legitimate peer review or editorial services

Predatory journals exploit the open-access fee model by accepting papers and collecting fees without conducting legitimate peer review, editorial oversight, or quality control.

Question 26: What does it mean when qualitative researchers describe their work as 'interpretivist'?

They apply standardized coding dictionaries to all texts
They use computer software to interpret data automatically
They interpret statistical results for non-technical audiences
They believe knowledge is subjectively constructed and context-dependent (Correct answer)

Correct answer: They believe knowledge is subjectively constructed and context-dependent

An interpretivist paradigm holds that social reality is subjectively meaningful, context-bound, and must be understood from the perspectives of those being studied.

Question 27: What is 'salami slicing' in research publication?

Misrepresenting statistical results in figures
Plagiarizing sections from previous publications
Dividing one study's results into several minimally publishable units (Correct answer)
Submitting the same paper to multiple journals at once

Correct answer: Dividing one study's results into several minimally publishable units

Salami slicing means breaking up one cohesive study into multiple small publications to maximize the number of papers, artificially inflating an author's output.

Question 28: In regression analysis, what does the R-squared value represent?

The proportion of variance in the outcome explained by the predictors (Correct answer)
The slope of the best-fit line
The number of predictors in the model
The statistical significance of each predictor

Correct answer: The proportion of variance in the outcome explained by the predictors

R-squared (coefficient of determination) indicates how much of the dependent variable's variability is accounted for by the independent variables.

Question 29: Which of the following best describes a key competency required for literature review & synthesis in CRS practice?

Memorization of all relevant regulations without understanding context
Reliance on a single methodology for all situations
The ability to work independently without any oversight
Strong analytical skills combined with effective communication and ethical judgment (Correct answer)

Correct answer: Strong analytical skills combined with effective communication and ethical judgment

CRS professionals working in literature review & synthesis need analytical skills to assess situations, communication skills to convey findings, and ethical judgment to make sound decisions.

Question 30: What is a 'preprint' in the scholarly communication process?

A summary sent to reviewers before the full manuscript
A manuscript posted publicly before formal peer review (Correct answer)
A printed copy distributed at conferences only
The final typeset version of an accepted article

Correct answer: A manuscript posted publicly before formal peer review

A preprint is an author's version of a research manuscript posted to a public server (e.g., arXiv, bioRxiv) before it undergoes formal peer review.

Question 31: A researcher wants to predict a binary outcome (pass/fail) from several continuous predictors. The most appropriate analysis is:

Factor analysis
Linear regression
MANOVA
Logistic regression (Correct answer)

Correct answer: Logistic regression

Logistic regression models the probability of a binary outcome as a function of predictor variables, producing odds ratios.

Question 32: Which term describes the practice of submitting the same manuscript simultaneously to multiple journals?

Duplicate submission
Salami slicing
Parallel submission (Correct answer)
Redundant publication

Correct answer: Parallel submission

Parallel (or simultaneous) submission—sending one manuscript to multiple journals at once—is an ethical violation, as most journals require exclusive submission.

Question 33: A researcher presenting findings at a conference should prioritize which of the following in their presentation design?

Reading directly from the written report
Maximizing the number of slides to fill the time slot
Including all raw data for completeness
Highlighting key findings with clear visuals and a logical narrative flow (Correct answer)

Correct answer: Highlighting key findings with clear visuals and a logical narrative flow

Conference presentations should distill key findings into a clear narrative supported by visuals, engaging the audience rather than replicating the written report.

Question 34: Which data quality issue occurs when records are counted more than once in a dataset?

Missing data
Duplication error (Correct answer)
Measurement invariance
Survivorship bias

Correct answer: Duplication error

Duplication errors inflate record counts and distort analyses, and must be identified and removed during data cleaning.

Question 35: What does 21 CFR Part 11 regulate in the context of clinical research?

Informed consent procedures
Electronic records and electronic signatures (Correct answer)
Drug manufacturing standards
IRB membership composition

Correct answer: Electronic records and electronic signatures

21 CFR Part 11 sets FDA requirements for the use of electronic records and electronic signatures in regulated clinical studies.

Question 36: Which effect size measure is most commonly reported alongside an independent samples t-test?

Odds ratio
Cramer's V
Cohen's d (Correct answer)
Eta-squared (η²)

Correct answer: Cohen's d

Cohen's d expresses the difference between two means in standard deviation units and is the standard effect size for t-tests.

Question 37: A researcher wants to ensure two reviewers are consistently applying inclusion criteria. The most appropriate metric is:

Cronbach's alpha
Cohen's kappa (Correct answer)
Pearson's r
Hedges' g

Correct answer: Cohen's kappa

Cohen's kappa measures inter-rater agreement beyond chance, making it the standard statistic for assessing consistency between screeners in systematic reviews.

Question 38: Which of the following best describes a key competency required for peer review & publication process in CRS practice?

The ability to work independently without any oversight
Memorization of all relevant regulations without understanding context
Strong analytical skills combined with effective communication and ethical judgment (Correct answer)
Reliance on a single methodology for all situations

Correct answer: Strong analytical skills combined with effective communication and ethical judgment

CRS professionals working in peer review & publication process need analytical skills to assess situations, communication skills to convey findings, and ethical judgment to make sound decisions.

Question 39: What is the purpose of role-based access control (RBAC) in research data security?

To ensure each user can only access the data necessary for their assigned role (Correct answer)
To encrypt all data stored at rest on servers
To anonymize participant data before analysis
To automatically back up data to multiple geographic locations

Correct answer: To ensure each user can only access the data necessary for their assigned role

RBAC restricts system access based on a user's defined role, ensuring individuals can only view or modify data relevant to their specific responsibilities.

Question 40: Which phenomenon describes survey respondents providing answers they believe are socially acceptable rather than truthful?

Acquiescence bias
Social desirability bias (Correct answer)
Halo effect
Ceiling effect

Correct answer: Social desirability bias

Social desirability bias occurs when respondents answer in ways they think will be viewed favorably rather than reporting their actual behavior or attitudes.

Question 41: An ethnographic researcher embeds with a community for six months to understand their culture from the inside. This is known as:

Secondary analysis
Quasi-experimental design
Systematic review
Participant observation (Correct answer)

Correct answer: Participant observation

Participant observation requires the researcher to actively engage with the community being studied to gain insider understanding.

Question 42: What is the term for journals that charge publication fees but provide little or no legitimate peer review, exploiting researchers?

Open-access journals
Predatory journals (Correct answer)
Hybrid journals
Society journals

Correct answer: Predatory journals

Predatory journals exploit the author-pays open-access model by charging fees without providing legitimate peer review, editorial services, or quality control.

Question 43: When a Request for Proposals (RFP) specifies a page limit, what is the best practice for a grant writer?

Use footnotes to add extra content not counted in the page limit
Submit slightly over the limit if the content is compelling
Request a waiver from the program officer before submission
Stay within the limit; exceeding it may result in automatic disqualification (Correct answer)

Correct answer: Stay within the limit; exceeding it may result in automatic disqualification

Most funders strictly enforce page limits, and submissions exceeding them are often rejected without review.

Question 44: Which type of grant funding is typically most competitive and requires the strongest evidence of innovation?

Capacity-building grants
Formula grants
Entitlement grants
Research and development (R&D) grants (Correct answer)

Correct answer: Research and development (R&D) grants

R&D grants fund new discoveries and innovations and are highly competitive because they require demonstrated scientific rigor and novelty.

Question 45: What is the primary purpose of a 'structured abstract' required by many journals?

To serve as a standalone peer-reviewed article
To list all funding sources and conflicts of interest
To replace the full manuscript for rapid-review journals
To organize key information under standardized headings for quick comprehension (Correct answer)

Correct answer: To organize key information under standardized headings for quick comprehension

Structured abstracts use predefined section headings (e.g., Background, Methods, Results, Conclusion) to help readers rapidly assess the study's key elements.

Question 46: What is the primary purpose of a research project's Work Breakdown Structure (WBS)?

To schedule the critical path of activities
To decompose project deliverables into manageable components (Correct answer)
To assign individual salaries to team members
To map stakeholder communication preferences

Correct answer: To decompose project deliverables into manageable components

A WBS decomposes the total project scope into smaller, manageable work packages to facilitate planning and control.

Question 47: Which qualitative data collection method involves in-depth conversation with a single participant guided by broad, open topics?

Focus group
Standardized test
Unstructured interview (Correct answer)
Cross-sectional survey

Correct answer: Unstructured interview

Unstructured interviews use open-ended questions and flexible conversation flow to explore a participant's perspectives in depth.

Question 48: What is the key distinction between a Phase II and Phase III clinical trial?

Phase II tests safety; Phase III tests manufacturing quality
Phase II uses animal models; Phase III uses human subjects
Phase II is optional; Phase III is mandatory
Phase II assesses preliminary efficacy; Phase III confirms efficacy in a larger population (Correct answer)

Correct answer: Phase II assesses preliminary efficacy; Phase III confirms efficacy in a larger population

Phase II trials evaluate preliminary efficacy and further assess safety in a moderate-sized group, while Phase III confirms efficacy and monitors adverse reactions in a large, definitive trial.

Question 49: Which of the following best describes a key competency required for institutional review board procedures in CRS practice?

Memorization of all relevant regulations without understanding context
The ability to work independently without any oversight
Reliance on a single methodology for all situations
Strong analytical skills combined with effective communication and ethical judgment (Correct answer)

Correct answer: Strong analytical skills combined with effective communication and ethical judgment

CRS professionals working in institutional review board procedures need analytical skills to assess situations, communication skills to convey findings, and ethical judgment to make sound decisions.

Question 50: Self-plagiarism in academic research is best defined as:

Using automated text-generation tools to write a manuscript
Reusing one's own previously published work without appropriate disclosure or attribution (Correct answer)
Paraphrasing published work without citing the original source
Copying a colleague's unpublished manuscript without permission

Correct answer: Reusing one's own previously published work without appropriate disclosure or attribution

Self-plagiarism occurs when researchers reuse substantial portions of their own prior publications without disclosing the overlap, misleading readers about the originality of the work.

Question 51: In federal grants, what does the term 'period of performance' refer to?

The timeframe during which project activities may be conducted and funds expended (Correct answer)
The number of years a PI has been conducting research
The review period used by the federal agency to evaluate the proposal
The window in which a grantee may appeal a funding decision

Correct answer: The timeframe during which project activities may be conducted and funds expended

The period of performance defines the start and end dates during which all project work must occur and funds must be spent.

Question 52: An unexpected, fatal serious adverse event (SAE) in a clinical trial must be reported to the FDA within how many calendar days?

7 days (Correct answer)
48 hours
30 days
15 days

Correct answer: 7 days

Unexpected fatal or life-threatening serious adverse events must be reported to the FDA within 7 calendar days of the sponsor's knowledge.

Question 53: Responsible Conduct of Research (RCR) training is federally required for trainees and students receiving support from which agency?

Department of Commerce
Environmental Protection Agency (EPA)
Department of Defense (DoD)
National Institutes of Health (NIH) (Correct answer)

Correct answer: National Institutes of Health (NIH)

NIH requires RCR training for graduate students, postdoctoral researchers, and undergraduate students supported by NIH training grants and career development awards.

Question 54: An external funder requests an unplanned interim report three weeks before a major data collection milestone. As project manager, what is your BEST course of action?

Assess the impact on the project schedule and negotiate scope or timeline adjustments (Correct answer)
Refuse the request as it is outside the original scope
Delay the data collection milestone to accommodate the report
Have the team work overtime to deliver both without any changes

Correct answer: Assess the impact on the project schedule and negotiate scope or timeline adjustments

Unplanned deliverables require an impact assessment followed by negotiation to adjust scope, schedule, or resources rather than absorbing the work silently.

Question 55: Honorary (gift) authorship violates research integrity primarily because it:

Misrepresents who actually contributed to the research and undermines accountability (Correct answer)
Prevents junior researchers from receiving proper first-author credit
Violates copyright law by listing too many contributors on a single paper
Inflates citation counts beyond norms acceptable to journal editors

Correct answer: Misrepresents who actually contributed to the research and undermines accountability

Honorary authorship falsely attributes credit and responsibility to individuals who did not meet authorship criteria, distorting the scientific record and undermining accountability.

Question 56: The Vancouver authorship criteria, established by ICMJE, require that all listed authors must contribute to:

Funding acquisition and manuscript formatting only
Data collection alone, if the dataset is very large
At least one revision round and responding to reviewer comments
Conception/design or data analysis, drafting or critically revising, approving the final version, AND accountability for the work (Correct answer)

Correct answer: Conception/design or data analysis, drafting or critically revising, approving the final version, AND accountability for the work

ICMJE's Vancouver criteria require all four elements: intellectual contribution, drafting/critical revision, final approval, and accountability—all must be met for authorship credit.

Question 57: Which US regulation addresses financial conflicts of interest for investigators in federally funded research?

45 CFR Part 46
21 CFR Part 50
21 CFR Part 312
42 CFR Part 50, Subpart F (Correct answer)

Correct answer: 42 CFR Part 50, Subpart F

42 CFR Part 50, Subpart F requires institutions to identify, manage, and report significant financial conflicts of interest held by investigators on federally funded research.

Question 58: What distinguishes a 'letter to the editor' from a standard research article in a journal?

It undergoes no review process before publication
It must report original randomized trial data
It is always longer and more detailed than a full article
It is typically a brief commentary responding to published work or reporting a small finding (Correct answer)

Correct answer: It is typically a brief commentary responding to published work or reporting a small finding

Letters to the editor are short communications—usually under 500 words—used to comment on published articles, report preliminary findings, or raise methodological concerns.

Question 59: Outcome reporting bias (selective reporting) threatens research integrity because it:

Distorts the published literature by reporting only significant or favorable outcomes while omitting others (Correct answer)
Violates participant confidentiality agreements in clinical studies
Significantly increases the time required for the peer review process
Increases the statistical power of a study beyond acceptable limits

Correct answer: Distorts the published literature by reporting only significant or favorable outcomes while omitting others

Selective outcome reporting inflates apparent effectiveness, contributes to publication bias, and gives readers a skewed picture of the available evidence.

Question 60: When a researcher incorrectly fails to reject a false null hypothesis, this is known as a:

Systematic bias
Sampling error
Type II error (Correct answer)
Type I error

Correct answer: Type II error

A Type II error (beta error) occurs when the null hypothesis is not rejected even though it is actually false.

Question 61: Under 21 CFR Part 50, which of the following is required before a subject can participate in a clinical trial?

Informed consent (Correct answer)
FDA clearance
Sponsor approval
IRB waiver

Correct answer: Informed consent

21 CFR Part 50 mandates that informed consent be obtained from all participants before enrollment in a clinical trial.

Question 62: Which federal agency oversees the regulation of clinical trials for drugs and biologics in the US?

NIH
CDC
FDA (Correct answer)
OHRP

Correct answer: FDA

The FDA regulates clinical trials for drugs, biologics, and medical devices in the United States.

Question 63: Which US federal office is primarily responsible for overseeing research integrity and investigating misconduct allegations at PHS-funded institutions?

Office of Research Integrity (ORI) (Correct answer)
FDA Center for Drug Evaluation and Research
NIH Office of Extramural Research
National Science Foundation Office of Inspector General

Correct answer: Office of Research Integrity (ORI)

The Office of Research Integrity (ORI) oversees and directs Public Health Service research integrity activities, including reviewing institutional investigations of misconduct allegations.

Question 64: What is a protocol deviation in clinical research?

An intentional, IRB-approved change to the protocol
An amendment submitted to the FDA
A change in the sponsor's funding source
Any departure from the approved study protocol procedures (Correct answer)

Correct answer: Any departure from the approved study protocol procedures

A protocol deviation is any departure from the approved study protocol, whether accidental or unavoidable, that must be documented and reported.

Question 65: What does a negative skewness value indicate about a distribution?

The distribution is bimodal
The tail extends further to the right
The distribution is symmetric
The tail extends further to the left (Correct answer)

Correct answer: The tail extends further to the left

Negative skewness indicates the distribution has a longer left tail, with most scores clustered at the higher end of the scale.

Question 66: Which federal regulation (the 'Common Rule') governs the protection of human subjects in federally funded research?

21 CFR Part 11
42 CFR Part 93
45 CFR Part 46 (Correct answer)
21 CFR Part 312

Correct answer: 45 CFR Part 46

45 CFR Part 46, known as the Common Rule, establishes federal standards for protecting human research subjects in federally funded studies.

Question 67: Which publishing model requires authors or their institutions to pay a fee so articles are freely available to all readers?

Hybrid closed access
Gold open access (Correct answer)
Subscription-based publishing
Green open access

Correct answer: Gold open access

Gold open access makes articles immediately and freely available on the publisher's website, typically funded through article processing charges (APCs) paid by authors.

Question 68: A manuscript that is sent back to authors with required changes before a final decision is given a:

Accept with minor edits
Desk rejection
Conditional rejection
Major revision decision (Correct answer)

Correct answer: Major revision decision

A major revision decision asks authors to make substantial changes and resubmit, with no guarantee of acceptance until the revised version is re-reviewed.

Question 69: A correlation coefficient of -0.85 between two variables indicates:

A strong negative relationship (Correct answer)
No relationship
A strong positive relationship
A weak positive relationship

Correct answer: A strong negative relationship

A coefficient near -1 indicates a strong inverse relationship: as one variable increases, the other decreases.

Question 70: When using SPSS to run a reliability analysis, under which menu option would a researcher find Cronbach's alpha?

Analyze > Descriptive Statistics > Frequencies
Analyze > Compare Means > One-Sample T Test
Analyze > Dimension Reduction > Factor
Analyze > Scale > Reliability Analysis (Correct answer)

Correct answer: Analyze > Scale > Reliability Analysis

Cronbach's alpha is computed via Analyze > Scale > Reliability Analysis in SPSS, where the researcher specifies the items to be assessed.

Question 71: A project manager observes that team velocity has dropped significantly during a lengthy research data coding phase. The MOST likely root cause to investigate first is:

Team burnout or unclear task assignments during a repetitive phase (Correct answer)
Inadequate project budget
Poor relationship with the project sponsor
Overly aggressive risk register

Correct answer: Team burnout or unclear task assignments during a repetitive phase

Velocity drops during repetitive phases commonly signal burnout, unclear priorities, or inadequate task breakdown rather than budget or sponsor issues.

Question 72: Under HIPAA, a de-identified dataset is one from which:

All 18 specified identifiers have been removed (Correct answer)
Only the PI can access the data
The data is stored in an offline system
All data has been encrypted

Correct answer: All 18 specified identifiers have been removed

HIPAA defines de-identification as the removal of all 18 specified identifiers that could link health information back to an individual.

Question 73: A 'sensitivity analysis' in a systematic review is used to:

Identify outlier data points in individual datasets
Test how robust the overall findings are when specific studies or assumptions are altered (Correct answer)
Increase the statistical power of the pooled estimate
Measure participants' sensitivity to an intervention

Correct answer: Test how robust the overall findings are when specific studies or assumptions are altered

Sensitivity analyses test whether conclusions change when borderline studies are excluded or different analytical assumptions are applied, checking the robustness of findings.

Question 74: The h-index is used to measure:

A journal's annual citation rate per article
A researcher's productivity and citation impact simultaneously (Correct answer)
The rejection rate of a specific journal
The number of peer reviews an author has completed

Correct answer: A researcher's productivity and citation impact simultaneously

The h-index (Hirsch index) equals h when a researcher has h papers each cited at least h times, capturing both output volume and citation impact.

Question 75: When synthesizing literature, 'transferability' is most relevant to which type of research?

Randomized controlled trials measuring efficacy
Large-scale epidemiological surveys
Secondary data analyses of administrative records
Qualitative studies assessing whether findings apply in other contexts (Correct answer)

Correct answer: Qualitative studies assessing whether findings apply in other contexts

Transferability, analogous to external validity in quantitative research, refers to how well qualitative findings can be applied to other settings or populations.

Question 76: What is the most effective way to measure success in peer review & publication process within CRS professional practice?

Count only the number of activities completed
Rely solely on supervisor opinion
Compare only with industry averages without considering context
Use a combination of quantitative metrics, qualitative assessments, and stakeholder feedback aligned with defined objectives (Correct answer)

Correct answer: Use a combination of quantitative metrics, qualitative assessments, and stakeholder feedback aligned with defined objectives

Effective measurement combines multiple data sources — quantitative metrics, qualitative assessments, and stakeholder feedback — all aligned with clearly defined objectives for a comprehensive evaluation.

Question 77: Which software is commonly used for quantitative data analysis?

SPSS (Correct answer)
Atlas.ti
NVivo
EndNote

Correct answer: SPSS

SPSS (Statistical Package for the Social Sciences) is a widely recognized and utilized software application specifically designed for statistical analysis of quantitative data. It offers a comprehensive suite of tools for data management, descriptive statistics, inferential statistics, and data visualization. Its user-friendly interface makes it a standard choice for researchers across various disciplines.

Question 78: The concept of 'therapeutic misconception' in research ethics refers to:

The false belief that placebos can have therapeutic effects
Participants incorrectly believing study procedures are tailored to their individual therapeutic needs (Correct answer)
Misrepresenting a drug's therapeutic index in a consent form
A researcher who believes their intervention will benefit all participants

Correct answer: Participants incorrectly believing study procedures are tailored to their individual therapeutic needs

Therapeutic misconception occurs when participants fail to distinguish research procedures from individualized clinical care, undermining truly informed consent.

Question 79: Which of the following best defines data fabrication in scientific research?

Using another researcher's dataset without proper attribution
Altering statistical outputs after analysis is complete
Selectively reporting only data that supports the hypothesis
Making up data, results, or findings and recording or reporting them as real (Correct answer)

Correct answer: Making up data, results, or findings and recording or reporting them as real

Data fabrication is the act of inventing or making up data, results, or findings that were never actually observed or collected.

Question 80: Grounded theory differs from other qualitative methods primarily because it:

Uses only structured interviews
Requires a pre-specified hypothesis
Focuses on numerical data
Aims to develop theory from collected data (Correct answer)

Correct answer: Aims to develop theory from collected data

Grounded theory is a systematic methodology that builds theory inductively from systematically gathered and analyzed data.

Question 81: PRISMA guidelines are used to standardize reporting of:

Clinical practice guidelines
Randomized controlled trials
Systematic reviews and meta-analyses (Correct answer)
Qualitative case studies

Correct answer: Systematic reviews and meta-analyses

PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) provides a checklist and flow diagram to ensure transparent and complete reporting of systematic reviews.

Question 82: Which of the following best describes a key competency required for research project management in CRS practice?

Reliance on a single methodology for all situations
Strong analytical skills combined with effective communication and ethical judgment (Correct answer)
The ability to work independently without any oversight
Memorization of all relevant regulations without understanding context

Correct answer: Strong analytical skills combined with effective communication and ethical judgment

CRS professionals working in research project management need analytical skills to assess situations, communication skills to convey findings, and ethical judgment to make sound decisions.

Question 83: How should CRS professionals handle confidential information related to research project management?

Delete all records after project completion
Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations (Correct answer)
Store information without any security measures
Share freely with all colleagues for transparency

Correct answer: Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations

Confidential information must be handled according to established protocols, regulatory requirements, and professional ethics standards, including proper access control and disclosure procedures.

Question 84: Which of the following is an example of an 'outcome' rather than an 'output' in a grant proposal?

A 20% increase in participants' job placement rates six months post-training (Correct answer)
100 training sessions delivered to program participants
50 brochures distributed to the target community
A new database system installed at the partner organization

Correct answer: A 20% increase in participants' job placement rates six months post-training

Outcomes measure changes in knowledge, behavior, or conditions resulting from a program, while outputs are the direct products of activities.

Question 85: According to ICMJE guidelines, all of the following criteria must be met to qualify as an author EXCEPT:

Drafting or critically revising the work for important intellectual content
Accountability for all aspects of the work's accuracy and integrity
Funding acquisition as the primary grant holder for the study (Correct answer)
Substantial contributions to conception, design, acquisition, or analysis of data

Correct answer: Funding acquisition as the primary grant holder for the study

ICMJE authorship requires intellectual contribution, drafting/revision, final approval, and accountability — funding acquisition alone does not qualify someone for authorship.

Question 86: What type of chart is best for showing proportions?

Pie chart (Correct answer)
Line chart
Histogram
Scatter plot

Correct answer: Pie chart

A pie chart is a circular statistical graphic that is divided into slices to illustrate numerical proportions. Each slice represents a category's share of the whole, making it an effective visual tool for displaying how different parts contribute to a total sum or percentage. This makes it ideal for showing relative sizes or distributions.

Question 87: What is a Data Management Plan (DMP) in research?

A required attachment to every IRB submission
A formal document describing how research data will be collected, stored, secured, and shared (Correct answer)
A plan for performing statistical analyses
A budget for purchasing data analysis software

Correct answer: A formal document describing how research data will be collected, stored, secured, and shared

A DMP is a formal document describing how research data will be managed throughout a study's lifecycle, including collection, storage, security, and long-term sharing.

Question 88: A researcher uses every 10th person on a list as a sample. This is an example of:

Cluster sampling
Purposive sampling
Simple random sampling
Systematic sampling (Correct answer)

Correct answer: Systematic sampling

Systematic sampling selects every kth element from a list, providing an efficient alternative to simple random sampling.

Question 89: In a normal distribution, approximately what percentage of data falls within two standard deviations of the mean?

68%
99.7%
50%
95% (Correct answer)

Correct answer: 95%

The empirical rule states that approximately 95% of data in a normal distribution lies within ±2 standard deviations of the mean.

Question 90: What is an IND application in clinical research?

Institutional Network Database
Independent Nursing Documentation
Investigational New Drug (Correct answer)
Informed Non-Disclosure

Correct answer: Investigational New Drug

An IND (Investigational New Drug) application must be filed with the FDA before testing a new drug in human subjects.

Question 91: How should CRS professionals handle confidential information related to peer review & publication process?

Delete all records after project completion
Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations (Correct answer)
Store information without any security measures
Share freely with all colleagues for transparency

Correct answer: Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations

Confidential information must be handled according to established protocols, regulatory requirements, and professional ethics standards, including proper access control and disclosure procedures.

Question 92: Which statement best describes 'post-publication peer review'?

Evaluation and critique of an article after it has been formally published (Correct answer)
Review conducted by journal subscribers who pay a fee
A second round of review before final typesetting
The process of updating a published article with new data

Correct answer: Evaluation and critique of an article after it has been formally published

Post-publication peer review allows the research community to formally comment on, critique, or endorse a published article, continuing quality assessment after publication.

Question 93: How is an adverse event (AE) defined in a clinical trial?

Only events that result in death or hospitalization
Events documented solely by the investigator at their discretion
Serious protocol deviations that harm participants
Any undesirable medical occurrence in a participant, regardless of causality (Correct answer)

Correct answer: Any undesirable medical occurrence in a participant, regardless of causality

An adverse event is any unfavorable or unintended medical occurrence in a clinical trial participant, whether or not considered related to the study treatment.

Question 94: How should CRS professionals handle confidential information related to institutional review board procedures?

Store information without any security measures
Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations (Correct answer)
Share freely with all colleagues for transparency
Delete all records after project completion

Correct answer: Follow established protocols for data protection, access control, and disclosure in accordance with applicable regulations

Confidential information must be handled according to established protocols, regulatory requirements, and professional ethics standards, including proper access control and disclosure procedures.

Question 95: Which of the following is a core area included in Responsible Conduct of Research (RCR) education as outlined by federal guidelines?

Animal care, clinical trials management, and statistical software training
Research mentoring, conflict of interest, data management, and research misconduct (Correct answer)
Grant budgeting, laboratory safety protocols, and publication formatting only
Participant recruitment, survey design, and literature review skills

Correct answer: Research mentoring, conflict of interest, data management, and research misconduct

Federal RCR guidelines identify key topics including mentorship, conflict of interest, data management, research misconduct, human subjects protection, and collaborative research.

Question 96: In the context of data collection, informed consent requires that participants:

Complete all portions of the study without withdrawal
Sign a legal waiver releasing the researcher from liability
Agree to participate after understanding the study's purpose and risks (Correct answer)
Have their data shared with a third-party sponsor

Correct answer: Agree to participate after understanding the study's purpose and risks

Informed consent is an ethical requirement ensuring participants voluntarily agree to join a study with full knowledge of what it involves and their right to withdraw.

Question 97: In SAS, what does PROC MEANS primarily compute?

Correlation matrices for continuous variables
Descriptive statistics such as mean, standard deviation, and n for numeric variables (Correct answer)
Frequency distributions for categorical variables
Regression coefficients for linear models

Correct answer: Descriptive statistics such as mean, standard deviation, and n for numeric variables

PROC MEANS computes descriptive statistics including N, mean, standard deviation, minimum, and maximum for numeric variables in a SAS dataset.

Question 98: A financial conflict of interest (COI) in research most commonly arises when:

A researcher competes for the same grant as a peer reviewer on the panel
A researcher receives funding from both NIH and NSF simultaneously
A researcher has financial ties to an entity that could bias research design, conduct, or reporting (Correct answer)
Two investigators disagree about the interpretation of shared findings

Correct answer: A researcher has financial ties to an entity that could bias research design, conduct, or reporting

Financial COI occurs when a researcher's personal financial interests — such as equity stakes, consulting fees, or royalties — could compromise the objectivity of their research.

Question 99: A study reports a confidence interval of [2.1, 4.8] for a mean difference. What does this mean?

The study found statistical significance at p < 0.05
The effect size is moderate
The true mean difference is definitely between 2.1 and 4.8
There is a 95% probability that this interval contains the true population parameter (Correct answer)

Correct answer: There is a 95% probability that this interval contains the true population parameter

A 95% confidence interval means that if the study were repeated many times, 95% of such intervals would contain the true population parameter.

Question 100: What does GCP stand for in the context of clinical research?

Government Clinical Policy
Global Compliance Program
General Clinical Protocol
Good Clinical Practice (Correct answer)

Correct answer: Good Clinical Practice

GCP (Good Clinical Practice) is an international ethical and scientific quality standard for designing, conducting, and reporting clinical trials.

Question 101: An executive summary in a research report primarily serves to:

Detail all statistical methods used
Replace the full report for most readers
Provide a brief overview for decision-makers who may not read the full report (Correct answer)
List all references cited in the study

Correct answer: Provide a brief overview for decision-makers who may not read the full report

An executive summary condenses key findings, conclusions, and recommendations so busy decision-makers can quickly grasp the study's significance.

Question 102: In experimental design, the variable that is measured as the outcome is called the:

Independent variable
Extraneous variable
Moderating variable
Dependent variable (Correct answer)

Correct answer: Dependent variable

The dependent variable is the outcome or response variable that researchers measure to assess the effect of the independent variable.

Question 103: Which sampling method selects participants randomly?

Quota sampling
Snowball sampling
Convenience sampling
Random sampling (Correct answer)

Correct answer: Random sampling

Random sampling is a probability sampling method where every member of the population has an equal chance of being selected for the study. This technique ensures that the sample is representative of the larger population, minimizing bias and increasing the generalizability of the research findings. It is a cornerstone for achieving statistical inference, allowing researchers to draw conclusions about the entire population from the sample data.

Question 104: A journal's 'embargo period' in the context of open access refers to:

The waiting period before a journal publishes supplementary materials
The period during which editors can retract an article without explanation
The delay before the author can self-archive or freely share the published work (Correct answer)
The time a manuscript spends under peer review before a decision

Correct answer: The delay before the author can self-archive or freely share the published work

An embargo period is the length of time (e.g., 6–12 months) that must pass after publication before authors can make their work freely available in a repository.

Question 105: A retraction notice in a scientific journal is issued primarily to:

Correct minor typographical or formatting errors without changing conclusions
Formally withdraw a published article due to major errors, misconduct, or irreproducible results (Correct answer)
Provide supplementary data that strengthens the original findings
Update the paper's authorship list after initial publication

Correct answer: Formally withdraw a published article due to major errors, misconduct, or irreproducible results

Retraction formally removes a flawed or fraudulent article from the scientific record, signaling to readers that the work should not be relied upon.

Question 106: Which analysis method tests relationships between variables?

Descriptive statistics
Qualitative analysis
Sampling
Correlation analysis (Correct answer)

Correct answer: Correlation analysis

Correlation analysis is a statistical method specifically designed to examine the strength and direction of a linear relationship between two or more quantitative variables. It helps researchers understand if and how variables move together, indicating a potential association. While it shows relationships, it's important to note that correlation does not imply causation.

Question 107: Which approach is most effective when tailoring a grant proposal to a specific funder?

Focus solely on the organization's past successes regardless of the funder's interests
Maximize the requested budget to provide flexibility for the project
Submit the same generic proposal template to all funders to save time
Align the proposal's language, priorities, and framing directly with the funder's stated mission and funding priorities (Correct answer)

Correct answer: Align the proposal's language, priorities, and framing directly with the funder's stated mission and funding priorities

Proposals that clearly reflect the funder's own language, values, and priorities demonstrate alignment and are far more competitive.

Question 108: Which practice is most consistent with maintaining research integrity when reporting analytical results?

Adjusting the significance threshold after viewing the data to better fit the findings
Rounding p-values to the nearest hundredth to simplify presentation
Including all pre-specified outcomes and analyses, whether results are significant or not (Correct answer)
Reporting only the statistical tests that yielded significant results to streamline the manuscript

Correct answer: Including all pre-specified outcomes and analyses, whether results are significant or not

Reporting all pre-specified outcomes and analyses, regardless of significance, is essential for transparency and prevents selective reporting bias in the scientific literature.

Question 109: When conducting a chi-square test of independence, what is the minimum expected cell frequency recommended to ensure test validity?

5 (Correct answer)
1
10
3

Correct answer: 5

The standard rule requires expected cell frequencies of at least 5 in each cell to ensure the chi-square approximation is valid.

Question 110: Triangulation in research means:

Applying trigonometry to spatial data
Randomly splitting data into thirds
Using a geometric sampling frame
Using multiple methods or data sources to validate findings (Correct answer)

Correct answer: Using multiple methods or data sources to validate findings

Triangulation enhances credibility by cross-checking results using different data sources, methods, investigators, or theories.

Question 111: What is the primary goal of phenomenological research?

To describe cultural norms of a specific group
To compare outcomes across multiple case studies
To generate theoretical models predicting human behavior
To understand the lived experience of a phenomenon as described by those who have experienced it (Correct answer)

Correct answer: To understand the lived experience of a phenomenon as described by those who have experienced it

Phenomenology seeks to uncover the essential, universal structures of conscious experience as described by participants who have lived through a phenomenon.

Question 112: A researcher wants to track whether field data collection is on schedule across multiple sites. Which tool provides the clearest visual comparison of planned vs. actual progress?

Affinity diagram
Gantt chart with baseline tracking (Correct answer)
Pareto chart
Fishbone diagram

Correct answer: Gantt chart with baseline tracking

A Gantt chart with a baseline overlay visually displays planned versus actual task completion across time.

Question 113: A researcher assigns odd-numbered participants to the experimental group and even-numbered participants to the control group. This is best described as:

Stratified random assignment
Convenience assignment
Systematic assignment (Correct answer)
Simple random assignment

Correct answer: Systematic assignment

Systematic assignment uses a non-random rule (like alternating numbers), making it quasi-experimental rather than truly random.

Question 114: Which of the following is considered data fabrication in research reporting?

Inventing data points or results that were never actually collected (Correct answer)
Rounding numerical results to two decimal places
Using statistics to summarize large datasets
Combining data from multiple sources into one dataset

Correct answer: Inventing data points or results that were never actually collected

Data fabrication is the creation of false data or results and is a serious form of research misconduct that violates scientific integrity.

Question 115: What is required before enrolling a minor in a clinical trial under federal regulations?

Written authorization from the Sponsor
An IRB waiver of the consent requirement
FDA pre-approval for each individual participant
Parental permission and, where appropriate, the child's assent (Correct answer)

Correct answer: Parental permission and, where appropriate, the child's assent

Federal regulations require parental or guardian permission and, where appropriate, the minor's own assent before enrolling a child in a clinical trial.

Question 116: Which principle of the Belmont Report specifically addresses the fair distribution of research burdens and benefits?

Beneficence
Non-maleficence
Respect for persons
Justice (Correct answer)

Correct answer: Justice

The Justice principle requires equitable selection of research subjects so that no group bears a disproportionate burden.

Question 117: In research project scheduling, what does 'float' (or slack) represent?

Extra budget reserved for unforeseen costs
The difference between planned and actual resource usage
The amount of time an activity can be delayed without delaying the project finish date (Correct answer)
The lag between dependent tasks

Correct answer: The amount of time an activity can be delayed without delaying the project finish date

Float is the amount of time a non-critical task can slip without affecting the overall project end date.

Question 118: What is the role of a control group in research?

Serve as baseline comparison (Correct answer)
Collect data only
Are excluded from analysis
Receive the experimental treatment

Correct answer: Serve as baseline comparison

In an experimental study, the control group is a group of participants who do not receive the experimental treatment or intervention. Their purpose is to provide a baseline against which the effects of the treatment administered to the experimental group can be compared. This allows researchers to determine if the observed changes in the experimental group are truly due to the intervention or other confounding factors, thus isolating the treatment's effect.

Question 119: A researcher is pressured by a senior colleague to list the department chair as a co-author, despite the chair having no involvement in the study. Accepting this request would constitute:

Honorary (gift) authorship, which violates research integrity and ICMJE standards (Correct answer)
A legitimate acknowledgment of the chair's administrative support for the research
Appropriate professional courtesy that is widely accepted in academic settings
A conflict of interest that must be disclosed in the manuscript's COI statement

Correct answer: Honorary (gift) authorship, which violates research integrity and ICMJE standards

Adding someone as an author who did not meet authorship criteria constitutes honorary or gift authorship, a recognized violation of research integrity principles.

Question 120: Under 42 CFR Part 93, which of the following is explicitly excluded from the definition of research misconduct?

Plagiarism of another researcher's published work
Falsification of research records
Honest differences in the interpretation of data (Correct answer)
Fabrication of experimental data

Correct answer: Honest differences in the interpretation of data

42 CFR Part 93 explicitly excludes honest error and differences of scientific opinion from the definition of research misconduct.

Question 121: When a researcher discovers a non-fraudulent error in their own published paper that does not affect the main conclusions, the appropriate response is to:

Make no public acknowledgment if the error is minor in scope
Publish a correction notice (erratum) through the journal (Correct answer)
Retract the entire paper and resubmit a corrected version to a different journal
Request that the journal quietly replace the PDF without a formal notice

Correct answer: Publish a correction notice (erratum) through the journal

An erratum or correction notice is the appropriate mechanism for transparently disclosing and correcting honest errors in published work that do not constitute misconduct.

Question 122: Pre-registration of a study (e.g., on ClinicalTrials.gov or the OSF) primarily serves to:

Establish intellectual property rights over the study design and protocol
Publicly document hypotheses, methods, and outcomes before data collection to prevent post-hoc manipulation (Correct answer)
Ensure IRB approval is automatically granted before data collection begins
Guarantee acceptance for publication in a peer-reviewed journal

Correct answer: Publicly document hypotheses, methods, and outcomes before data collection to prevent post-hoc manipulation

Pre-registration creates a timestamped public record of planned hypotheses and analyses, making it possible to distinguish confirmatory from exploratory findings and deter p-hacking.

Question 123: What does the acronym FFP represent in the context of research misconduct?

Fabrication, Fraud, and Publication
Funding, Fabrication, and Publication
Fraud, Falsification, and Prevention
Fabrication, Falsification, and Plagiarism (Correct answer)

Correct answer: Fabrication, Falsification, and Plagiarism

FFP stands for Fabrication, Falsification, and Plagiarism — the three categories of research misconduct defined by US federal policy (42 CFR Part 93).

Question 124: What is the primary purpose of a Data Safety Monitoring Board (DSMB) in a clinical trial?

To write the study protocol
To manage trial finances
To independently review accumulating safety and efficacy data (Correct answer)
To recruit participants

Correct answer: To independently review accumulating safety and efficacy data

A DSMB independently reviews accumulating safety and efficacy data to protect participant welfare throughout a trial.

Question 125: When a data collection instrument consistently measures the same construct the same way, it demonstrates:

Concurrent validity
External validity
Reliability (Correct answer)
Construct bias

Correct answer: Reliability

Reliability refers to the consistency of a measurement instrument across repeated administrations or raters.

Certified Research Specialist (CRS)

The CRS certification validates expertise in clinical research principles, regulations, and ethics. It tests candidates on research integrity, data management, regulatory compliance, and the scientific publication process for research professionals.

125

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120 min

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