Mixed Deck — All CRP Topics Flashcards

In program evaluation, 'stakeholder engagement' is considered important primarily because it:

Answer: Increases the likelihood that evaluation findings will be relevant, credible, and used

Engaging stakeholders throughout the evaluation improves relevance, builds buy-in, and makes it far more likely that findings will inform decisions and actions.

A multi-site clinical trial uses a central IRB (cIRB) for review. Under the 2018 Revised Common Rule, which of the following is TRUE regarding cIRB use for domestic sites?

Answer: A single cIRB review is required for domestic cooperative research under the Revised Common Rule

The 2018 Revised Common Rule mandates that domestic sites cooperating in multi-site research rely on a single IRB unless an exception is granted.

The counterfactual in an impact evaluation refers to:

Answer: What would have happened to participants had they not received the intervention

The counterfactual represents the unobserved state — what outcomes would have looked like without the intervention — which is estimated through comparison groups.

Under 21 CFR Part 312, sponsors must report unexpected fatal or life-threatening suspected adverse reactions (IND safety reports) within:

Answer: 7 calendar days

FDA regulations require sponsors to report unexpected fatal or life-threatening suspected adverse reactions within 7 calendar days of initial receipt of information.

A clinical investigator receives an honorarium from a pharmaceutical company whose drug they are studying. Under 21 CFR Part 54, this financial relationship must be:

Answer: Disclosed to the FDA as part of the financial disclosure certification

21 CFR Part 54 requires sponsors to certify or disclose investigators' financial interests to the FDA to allow assessment of potential bias in study data.

A qualitative researcher is studying domestic violence survivors. Which recruitment strategy raises the greatest ethical concern?

Answer: Recruiting through social media posts in closed survivor support groups

Recruiting from closed support groups can breach the confidentiality of members and may expose them to undue risk of identification.

When using systematic random sampling, a researcher selects every 10th person from a list of 500. What is the sampling interval?

Answer: 10

The sampling interval is 10 because every 10th element is selected from the population list.

A participant calls a research team and states they want to withdraw from a study. What must the team do?

Answer: Honor the withdrawal immediately without penalty or loss of benefits

Participants have an unconditional right to withdraw at any time without penalty or loss of otherwise entitled benefits.

The Hawthorne Effect refers to which phenomenon in research?

Answer: Participants performing better simply because they know they are being observed

The Hawthorne Effect describes the tendency for people to modify their behavior when they know they are being studied or observed.

Which sampling approach would be most appropriate when the researcher wants to ensure proportional representation of subgroups within the sample?

Answer: Stratified random sampling

Stratified random sampling divides the population into subgroups (strata) and samples proportionally from each, ensuring representation of all groups.

A research director is building a culture of continuous improvement within the department. Which practice best supports this goal?

Answer: Institutionalizing regular after-action reviews, transparent sharing of lessons learned, and iterative process improvement cycles

Continuous improvement cultures are built through regular reflection, transparent learning, and iterative cycles that are embedded into the team's normal workflow.

A researcher notices that survey response rates drop significantly after question 20 in a 40-question survey. This phenomenon is best described as:

Answer: Respondent fatigue

Respondent fatigue occurs when participants become tired or disengaged during long surveys, leading to lower quality responses or dropout.

Which documentation practice best supports legal defensibility?

Answer: Objective, factual entries with specific measurements and timestamps

Objective, factual entries with specific measurements and timestamps provide the strongest legal defense by demonstrating thorough, unbiased professional practice.

Pre-specified 'stopping rules' in a clinical trial protocol are designed to:

Answer: Halt or modify the trial if predefined safety thresholds are crossed

Stopping rules are prospectively defined safety thresholds (e.g., excess mortality, specific AE rates) that trigger mandatory trial suspension or protocol modification to protect participants.

According to ICH E6(R2), essential documents must be retained for at least how long after the completion or discontinuation of a trial?

Answer: As specified by applicable regulatory requirements, typically at least 2 years after the last approval of marketing application

ICH E6(R2) requires retention of essential documents for at least 2 years after the last approval of a marketing application in an ICH region, or as otherwise required by regulations.

Which method involves observing subjects in their natural environment?

Answer: Observational

Observational research involves systematically watching and recording subjects' behavior in their natural settings without intervention. This method allows researchers to gather authentic data on how individuals or groups behave in real-world contexts, providing rich insights that might not be captured through other methods.

A research firm stores encrypted respondent data in a cloud environment hosted in a foreign country. What ethical/legal issue is most likely to arise?

Answer: Cross-border data transfers may violate respondents' country-of-origin data protection laws

Transferring personal data across borders may violate data protection regulations (e.g., GDPR) that restrict where and how personal data can be processed.

A researcher is preparing a poster presentation. Which layout principle best guides viewer comprehension?

Answer: Use a logical flow (introduction → methods → results → conclusion) with visuals to guide the eye

Effective posters guide viewers through the research narrative with clear section flow, white space, and visual aids rather than text-heavy dense layouts.

What is the purpose of a protocol deviation report?

Answer: To document and assess instances where protocol requirements were not followed

Protocol deviation reports document unplanned departures from the approved protocol and assess their impact on participant safety and data integrity.

In clinical trial management, what is 'randomization'?

Answer: Random assignment of participants to study groups to reduce bias

Randomization assigns participants to treatment or control groups by chance, minimizing selection bias and confounding.