Mixed Deck — All RA Topics Flashcards

Which sampling method gives every member of the population an equal chance of selection?

Answer: Simple random sampling

Simple random sampling gives each population member an equal probability of being chosen.

What is the purpose of a grant progress report?

Answer: To document accomplishments and update the funder on project status

Progress reports inform the funding agency of the research accomplishments, challenges encountered, and activities planned for the upcoming period.

Who may approve a waiver or alteration of HIPAA authorization for research?

Answer: An IRB or Privacy Board

The HIPAA Privacy Rule allows an IRB or Privacy Board to approve a waiver of authorization when criteria are met.

A participant cannot read but wishes to enroll. Under FDA and GCP guidance, what is typically required during consent?

Answer: An impartial witness present for the entire consent discussion who also signs the form

An impartial witness attests that the information was accurately explained and that consent was freely given.

The smallest change in a score that participants perceive as meaningful is known as what?

Answer: Minimal clinically important difference (MCID)

The MCID is the smallest score change considered meaningful to patients or clinicians.

When working with liquid nitrogen in a small storage room, which hazard is often overlooked in addition to cold burns?

Answer: Oxygen-deficient atmosphere causing asphyxiation

Evaporating nitrogen displaces oxygen, so poorly ventilated rooms need oxygen monitors.

In research measurement, internal consistency reliability is most commonly assessed using:

Answer: Cronbach's alpha

Cronbach's alpha is the standard measure of internal consistency, evaluating how closely related a set of items in a scale are to each other as a group.

Concluding that a drug works when it actually has no effect is which type of error?

Answer: Type I error

A Type I error is a false positive, meaning a true null hypothesis is rejected, and its probability is set by alpha.

After a serious protocol deviation caused by a staff knowledge gap, what training response is most appropriate?

Answer: Targeted retraining documented as part of the corrective and preventive action (CAPA)

Documented targeted retraining is a standard CAPA step for deviations caused by gaps in knowledge.

Cronbach's alpha is most commonly used to estimate which characteristic of a multi-item scale?

Answer: Internal consistency reliability

Cronbach's alpha measures how closely related a set of items are as a group, which is internal consistency.

Which standardized dictionary is commonly used to code adverse event terms in clinical trial databases?

Answer: MedDRA

MedDRA is the international medical terminology used to code adverse events for regulatory reporting.

What quality assurance measure supports professional standards and ethics?

Answer: Regular self-assessment, peer review, and adherence to established standards

Ongoing quality assurance through self-assessment, peer review, and standards adherence ensures continuous improvement.

An IRB may waive documentation of informed consent when the only record linking the subject to the research would be the consent form and the principal risk is:

Answer: Potential harm from a breach of confidentiality

45 CFR 46.117(c) allows waiving signed consent when the signed form itself is the main confidentiality risk.

What is the role of Institutional Review Boards (IRBs) in research?

Answer: To review and approve research proposals to ensure ethical standards.

Institutional Review Boards (IRBs) play a critical role in research by reviewing and approving all research proposals involving human participants. Their primary function is to ensure that studies meet ethical standards, protecting the rights and welfare of individuals. This oversight guarantees that research is conducted responsibly and ethically.

Which statistic is commonly used to measure agreement between two raters classifying the same categorical outcomes, corrected for chance?

Answer: Cohen's kappa

Cohen's kappa measures inter-rater agreement for categorical ratings and adjusts for agreement expected by chance.

An EDC system flags an entered age of 250 years right away. What kind of feature is this?

Answer: Range (edit) check

Range checks are automated edit checks that flag values outside plausible limits when they are entered.

What is the main reason for blinding outcome assessors in a clinical study?

Answer: To reduce measurement bias in outcome assessment

Assessors who do not know treatment assignments cannot let expectations influence how they rate outcomes.

A coordinator documents a study visit three days after it happened. How should the entry be handled?

Answer: Label it as a late entry, give the actual date it was written, and initial it

Late entries are allowed if they are clearly marked and dated with the actual date they were written.

Which best describes the role of a Data and Safety Monitoring Board (DSMB)?

Answer: Independently reviewing accumulating data to protect participant safety and study integrity

A DSMB is an independent group that reviews interim data and can recommend continuing, modifying, or stopping a trial.

What is the primary purpose of ethical standards in research?

Answer: To protect the rights and well-being of participants.

Ethical standards in research are primarily established to safeguard the rights, dignity, and well-being of all participants. This includes protecting them from harm, ensuring their privacy, and respecting their autonomy throughout the study. Adherence to these standards is fundamental for maintaining public trust in scientific research and upholding moral principles.