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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. Identify the CDISC model with the following characteristics:
XML-based content and format standard facilitates the archive and interchange of the metadata and data for clinical research provides an accurate audit trail that is 21 CRF Part II compliant

A) Operational Data Model (ODM)
B) Study Data Tabulation Model (SDTM)
C) Analysis Data Model (ADaM)
D) Trial Design Model (TDM)

2. This question will ask you to provide a line of missing code.
Given the dataset RAWBP that is sorted by SUBJECT TEST WEEK:

Which statement must be added to the program to calculate relative change in percent (percent change) from baseline?

A) pct_chg = ((baseline - value) /value)*100;
B) pct_chg = ((value - baseline) /value)*100;
C) pct_chg = ((baseline - value) /baseline)*100;
D) pct_chg = ((value - baseline) /baseline)*100;

3. Which program will report all created output objects in the log?

A) ods trace=log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
B) proc ttest data=WORK.DATA1 ods=trace; class TREAT; var RESULTS; run;
C) ods trace log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
D) ods trace on; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;

4. What is the definition for treatment-emergent adverse event (TEAE)?

A) AE that started 6 months after the last dose of study drug
B) AE that continued after the first dose of study drug
C) AE that improved after the first dose of study drug
D) AE that started or worsened after the first dose of study drug

5. Which is an acceptable variable label in a V5 transport file for regulatory submission?

A) Character Result/Finding in Std Format
B) Category for Reproductive System Findings
C) Numeric Result/Finding in Standard Format
D) Reason Medical History Not Done or Not Occurred

Solutions: