Free SAS Institute A00-282 Exam Questions

Become SAS Institute Certified with updated A00-282 exam questions and correct answers

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Total 145 Questions | Updated On: Oct 29, 2025

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Question 1

When implementing define.xml as part of a clinical trial study data submission package, which section is pivotal for explaining algorithmic derivations and handling of special data scenarios to a regulatory reviewer?

A : The dataset-level metadata section outlining dataset structure and content.

B : The variable-level metadata section describing characteristics and properties of each variable.

C : The computational algorithms and derivation methodology section clarifying complex programming logic.

D : The controlled terminology section ensuring conformance with industry standards for terminology.

Answer: C

Question 2

A pharmaceutical company is preparing submission materials for a new drug application. One of the key documents required by regulatory authorities is define.xml. Which of the following best describes the purpose of the define.xml file?

A : It describes the statistical analysis methods and displays the computational algorithms used.

B : It serves as a data dictionary to define data sets, variables, and other metadata related to clinical trial data.

C : It is the primary dataset that contains all patient-level data collected during the trial.

D : It provides a detailed chronological narrative of the clinical study design and its amendments.

Answer: B

Question 3

A clinical trial dataset is being prepared for statistical analysis and submission to a regulatory authority. Which of the following best describes the purpose of applying the CDISC Analysis Data Model (ADaM) standards to the dataset?

A : To define the dataset in a way that is specific to the individual clinical trial without consideration for cross-study comparisons.

B : To ensure that the dataset only includes variables that are directly derived from the Case Report Form (CRF).

C : To standardize the dataset structure and variables to facilitate efficient review by regulatory authorities and ensure consistency across studies.

D : To anonymize the clinical trial data to protect patient confidentiality before submission to regulatory agencies.

Answer: C

Question 4

Which key organization is responsible for oversight and approval of clinical trials in the United States, ensuring that they are conducted according to regulatory requirements to safeguard participant health and collect reliable data?

A : The National Institutes of Health (NIH)

B : The Food and Drug Administration (FDA)

C : The European Medicines Agency (EMA)

D : The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Answer: B

Question 5

A clinical trial analyst needs to create a Kaplan-Meier survival plot to visualize the time-to-event data for different treatment groups. Which PROC step should the analyst use, and what is the key statement to differentiate the treatment groups in the graph?

A : PROC GPLOT with a BY statement

B : PROC LIFETEST with a STRATA statement

C : PROC SGPLOT with a SERIES statement

D : PROC PHREG with a CLASS statement

Answer: B

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Total 145 Questions | Updated On: Oct 29, 2025

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