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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Objectives |
|---|---|
| Topic 1: Clinical Trials Data Standards | - CDISC Standards
|
| Topic 2: SAS Programming for Clinical Trials | - Data Management
|
| Topic 3: Regulatory and Clinical Research Concepts | - Clinical trial workflow
|
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
When writing a validation program using independent programming, which two actions conform to good programming practices?
(Choose two.)
- A. Ensure the production program has been run prior to compare.
- B. Copy statistical code directly from the production program.
- C. Delete subjects from the production side that are causing differences with the validation data set.
- D. Copy statistical code directly from the SAP.
Which statement describes an aspect of all Phase II clinical trials?
- A. in vitro and in vivo experiments using wide-ranging doses of the drug
- B. designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a drug
- C. designed to assess how well the drug works and further assess safety
- D. randomized controlled multicenter trials on large patient groups
This item will ask you to determine the missing code.
In the data shown below, each record represents a single treatment period and contains a character SUBJID and non-missing numeric dates EXSTDT and EXENDT.
The Duration of Treatment (in days) for a single period is defined as Treatment End Date - Treatment Start Date + 1. For each subject, the Total Duration (in days) is defined as the sum of durations of treatment across all treatment periods.
Which code segment generates the new data set, EX2, which contains a single record per subject and includes the Duration of Treatment?
data EX2
set EX;
by subjid exstdt exendt;
<insert code here>
run;
- A. duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt; - B. retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt; - C. retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then Totaldur = duration;
if last.subjid; - D. duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then TotalDur = duration;
if last.subjid;
What is the primary purpose for specifying identifier variables across SDTM domains?
- A. To include the appropriate study information
- B. To uniquely reference each record
- C. To satisfy regulatory conditions
- D. To include the appropriate subject information
You want to calculate the p-value of Fisher's exact test for a 3x3 table.
Which option must you add to the TABLES statement of PROC FREQ?
- A. CMH
- B. CHISQ
- C. EXPECTED
- D. EXACT
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