Updated: Sep 05, 2026
No. of Questions: 144 Questions & Answers with Testing Engine
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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 2: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 3: Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Debugging macros - Create and call macros |
| Topic 4: Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Topic 5: Manage Clinical Trials Data | 5% | - Access and explore clinical datasets - Use SQL and dictionary tables - Clean, merge, and subset data |
| Topic 6: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 7: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Derive variables and study days - Aggregation and transposition |
| Topic 8: Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Define.xml and dataset specifications - Clinical domain structures |
| Topic 9: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
In a study, inclusion criteria required patients be between 18 and 65. Patients will be analyzed in 2 age groups: group one is subjects who are under 36 years of age and group two is subjects who are 36 years of age or older.
Which statements properly assign age group, and writes an error message to the log for any patient with an out of range age value?
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;
The following SAS program is submitted.
What result is displayed for the variable COUNT?
Review the following procedure format:
PROC TTEST date=date;
class group-variable;
var variable;
run;
What is the required type of data for the variable in this procedure?
Given two data sets with the following variables:
Why is the blue note showing in the log?
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