Mixed Deck — All CRA Topics Flashcards

Under ICH-GCP, which of the following constitutes an 'essential document'?

Answer: Documents that individually and collectively permit evaluation of the conduct of a trial and quality of data

ICH E6(R2) Section 8 defines essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.

Which sampling method divides the population into mutually exclusive groups and randomly samples from each?

Answer: Stratified sampling

Stratified sampling segments the population into strata (e.g., age groups) and draws random samples from each to ensure representation.

Under the HIPAA Privacy Rule, a 'limited data set' may be used for research without individual authorization provided:

Answer: A data use agreement is in place and direct identifiers are removed

A limited data set retains some indirect identifiers but may be used for research under a data use agreement without individual authorization.

In quantitative research, a p-value of 0.03 means:

Answer: There is a 3% probability of obtaining results this extreme if the null hypothesis is true

A p-value represents the probability of observing data as extreme as the sample, assuming the null hypothesis is true — not the probability that any hypothesis is correct.

Which situation best justifies performing a meta-analysis rather than a narrative synthesis in a systematic review?

Answer: Studies are sufficiently clinically and methodologically homogeneous to allow meaningful pooling

Meta-analysis is appropriate when included studies are sufficiently similar in population, intervention, comparator, and outcome to justify combining their results statistically.

Multiple testing in a clinical trial without correction inflates the probability of:

Answer: Type I error

Each additional hypothesis test at alpha=0.05 adds a 5% chance of a false positive; without correction, the family-wise Type I error rate exceeds alpha.

Which term describes the document that maps each data field in the EDC to its corresponding location on the paper CRF or protocol?

Answer: Annotated CRF

The annotated CRF marks each data field with its EDC variable name, form name, and visit, serving as a reference between the paper format and the electronic database structure.

Which of the following is a key component of 21 CFR Part 11 compliance for EDC systems?

Answer: Use of secure, computer-generated, time-stamped audit trails that record operator entries and actions

21 CFR Part 11 requires that electronic records maintain secure, computer-generated, time-stamped audit trails that cannot be disabled or modified by regular users.

Stratified random sampling improves upon simple random sampling by:

Answer: Ensuring proportional representation of key subgroups within the sample

Stratified random sampling divides the population into subgroups (strata) and randomly samples from each, ensuring adequate representation of important segments.

What is the primary purpose of a kit number or bottle number on investigational product in a blinded study?

Answer: To uniquely identify and track each unit of IP while maintaining blinding

Kit and bottle numbers uniquely identify each unit of investigational product, enabling full accountability and tracking without revealing the treatment assignment in blinded studies.

What is the significance of an electronic signature in an EDC system, per 21 CFR Part 11?

Answer: It is legally binding and equivalent to a handwritten signature when the system meets all Part 11 requirements

Under 21 CFR Part 11, electronic signatures carry the same legal weight as handwritten signatures, provided the system meets all specified security and audit requirements.

An IRB grants expedited review to a study. This means the research involves:

Answer: No more than minimal risk and fits an approved category

Expedited review applies to research involving no more than minimal risk that falls within specific federally approved categories.

A researcher uses a two-tailed test instead of a one-tailed test for the same hypothesis. How does this affect the critical region?

Answer: It splits alpha across both tails

A two-tailed test splits alpha (e.g., 0.05) equally into both tails, placing 0.025 in each tail.

What does ICH E6(R2) specify about the investigator's financial interests in a clinical trial?

Answer: Financial arrangements between the sponsor and investigator should be documented and any conflict of interest disclosed to the IRB/IEC

ICH E6(R2) requires that financial arrangements and any potential conflicts of interest between sponsors and investigators be documented and disclosed to the IRB/IEC as required.

When a CRA conducts source data verification (SDV) using an EDC system, what is being compared?

Answer: Data entered in the eCRF against the original source documents at the site (e.g., medical records, lab reports)

SDV is the process of checking that data recorded in the eCRF exactly matches the original source data from which it was transcribed, confirming accuracy and completeness.

What is the 'intent-to-treat' (ITT) principle as applied in Phase III confirmatory trials?

Answer: All randomized subjects are included in the primary efficacy analysis regardless of protocol adherence

The ITT principle includes all randomized subjects in the primary analysis in the groups to which they were randomized, preserving the integrity of randomization.

A CRA professional encounters an unfamiliar situation while performing quantitative & qualitative methods duties. What is the most appropriate first action?

Answer: Consult relevant standards, guidelines, or a qualified supervisor before proceeding

When facing unfamiliar situations in quantitative & qualitative methods, the most appropriate action is to consult relevant standards, guidelines, or a qualified supervisor. This ensures safety, accuracy, and compliance while building professional knowledge.

A researcher wants to establish causality between a marketing campaign and sales lift. Which design is most appropriate?

Answer: Randomized controlled experiment

A randomized controlled experiment allows the researcher to isolate the causal effect of the campaign by controlling for confounding variables.

Effect size in quantitative research is important because it:

Answer: Indicates the practical or substantive magnitude of a finding, independent of sample size

Effect size quantifies the magnitude of a relationship or difference, providing practical significance that statistical significance alone cannot convey.

A Kaplan-Meier curve that drops steeply early and then flattens indicates:

Answer: Most events occur early in follow-up

A steep early drop followed by a plateau means the majority of events (deaths, failures) happened soon after study entry.