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| Section | Objectives |
|---|---|
| Clinical Trials Data Standards | - CDISC Standards
|
| Regulatory and Clinical Research Concepts | - Clinical trial workflow
|
| SAS Programming for Clinical Trials | - Reporting and Analysis
|
1. Which two features are captured by the events general observation class of SDTM? (Choose two.)
A) Investigational or therapeutic treatments
B) Planned protocol milestones
C) Subject characteristics
D) Planned evaluations
2. What is the primary purpose of programming validation?
A) Efficiently ensure any logic errors are discovered early in the programming process.
B) Ensure that the output from both the original program and the validation program match.
C) Justify the means used to accomplish the outcome of a program and ensure its accurate representation of the original data.
D) Document all specifications pertaining to programmed output and ensure all were reviewed during the programming process.
3. This question will ask you to provide a line of missing code.
Which statement must be added to the following program to create a page break in the report after each RACE grouping?
A) break after race;
B) break page / race;
C) break race / page;
D) break after race / page;
4. The following partial output was produced from the SAS Dictionary Tables.
Which SQL statement produced this output?
A) proc sql;
select scope, name from dictionary.macros
where scope = 'GLOBAL';
quit;
B) proc sql;
select * from dictionary.macros
where scope = 'global';
quit;
C) proc sql;
select scope, name from dictionary.macros
where scope = 'global';
quit;
D) proc sql;
select * from dictionary.macros
where scope = 'GLOBAL';
quit;
5. The following SAS program is submitted:
proc univariate date=work.STUDY; by VISIT; class REGION TREAT; var HBA1C GLUCOS; run; You want to store all calculated means and standard deviations in one SAS data set.
Which statement must be added to the program?
A) output mean std;
B) ods output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
C) output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
D) ods output mean=m1 m2 std=s1 s2;
Solutions:
| Question # 1 Answer: B,D | Question # 2 Answer: C | Question # 3 Answer: D | Question # 4 Answer: A | Question # 5 Answer: C |
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