Last Updated: Aug 11, 2026
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| Section | Objectives |
|---|---|
| Topic 1: Clinical Trials Data Standards | - CDISC Standards
|
| Topic 2: Regulatory and Clinical Research Concepts | - Clinical trial workflow
|
| Topic 3: SAS Programming for Clinical Trials | - Reporting and Analysis
|
1. Given the following data set (AE):
Data will be reported by onset week. Day 1?
7 is Week 1, Day 8 ?14 is Week 2. Events beyond Day 14 are assigned Week 3 and will be reported as Follow-up events.
Which statements properly assign WEEK to each event?
A) select; when (day > 14) week = 3; when (day > 7) week = 2; otherwise week = 1; end;
B) if day > 14 then week = 3; else if day > 7 then week = 2; else if day > 0 then week = 1;
C) if day > 0 then week = 1; else if day > 7 then week = 2; else if day > 14 then week = 3;
D) select; when (day > 0) week = 1; when (day > 7) week = 2; otherwise week = 3; end;
2. In CDISC, which of the following describes the usage of controlled terms, code lists, or formats?
A) Establishes consistent variable labels
B) Establishes consistent variable values
C) Establishes consistent variable names.
D) Establishes consistent variable types.
3. The purpose of the ADaM model is to provide a framework that:
A) enables the tabulation of the raw source data
B) enables the statistical analysis of the data
C) enables the creation of study patient profiles
D) can be used to generate the CDISC ODM
4. Which code segment includes a statement that would reset the graphics counter and ensure a 6in by
4in image is produced?
A) ods graphics / counter = 1 width = 6in height = 4in;
B) ods graphics / width = 6in height = 4in reset;
C) ods graphics / reset width = 6in height = 4in;
D) ods graphics / width = 6in height = 4in counter = 1;
5. Define.xml is an XML-based submission of a clinical study's:
A) data
B) protocol
C) results
D) metadata
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: D |
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