# SAS a00-281 practice test

## Clinical Trials Programming Using SAS 9 Accelerated Version Exam

##### Question 1

Given the following SAS program:

Which statement correctly identifies invalid values in the variable TRT, if only the values 'A', B', 'C are
valid?

• A. if indexc(TRT, 'ABC') eq 0 then output;
• B. if index(TRT, 'ABC') eq 0 then output;
• C. if find(TRT, 'ABC') eq 0 then output;
• D. if indexw(TRT, 'ABC') eq 0 then output;

A

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##### Question 2

A Statistical Analysis Plan describes a clinical trial as "A 12 week, double-blind, placebo-controlled,
randomized, multi-center study." Double-blind refers to which groups in this study?

• A. treatment and control group
• B. investigator and subjects
• C. statistician and sponsor
• D. sponsor and investigator

B

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##### Question 3

A patient received at least one dose of study medication prior to withdrawing from a study. Which
analysis population would always include this patient?

• A. efficacy
• B. intent to treat
• C. per protocol
• D. safety

D

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##### Question 4

What is an international ethical and scientific quality standard for designing, conducting, recording
and reporting trials that involve the participation of human subjects?

• A. 21 CFR Part 11
• B. Good Clinical Practices
• C. MedDRA
• D. WHODrug

B

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##### Question 5

What is the main focus of 21 CFR Part 11?

• A. electronic submission requirements
• B. trial safety requirements
• C. statistical calculation requirements
• D. trial protocol requirements

A

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##### Question 6

An action plan that describes what will be done in a drug study, how it will be conducted, and why
each part of the study is necessary is called:

• A. a clinical trial plan
• B. a protocol
• C. a data management plan
• D. a statistical analysis plan

B

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##### Question 7

From the Statistical Analysis Plan, patients age is calculated as an integer relative to date randomized
divided by 365.25. Given the following annotated CRF:

Which programming code defines the patient's age?

• A. age = int((birthdt-randdt)/365.25);
• B. age = int((randdt-birthdt)/365.25);
• C. age= int(yrdif(birthdt,randdt, "act/365.25" ));
• D. age = int((today()-birthdt)/365.25);

B

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##### Question 8

A Statistical Analysis Plan (SAP) defines the selection process for baseline records. This instructs the
programmer to choose the last non-missing analyte value prior to first study drug administration
(date/time). The DEMO data set contains the date/time of first study drug administration for subject:

What will be the resulting baseline values, as selected per the SAP instructions?

• A. Option A
• B. Option B
• C. Option C
• D. Option D

D

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##### Question 9

Which statement correctly describes an aspect of a Phase II clinical trial?

• A. randomized controlled multicenter trials on large patient groups
• B. designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a drug
• C. in vitro and in vivo experiments using wide-ranging doses of the drug
• D. designed to assess how well the drug works

D

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##### Question 10

CORRECT TEXT
Which CDISC filename contains the following items?
Variable attributes
Controlled terminology
Computational methods
Enter your answer in the space below (Case is ignored. Do not add leading or trailing spaces to your