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SASInstitute A00-282 Exam Syllabus Topics:

SectionWeightObjectives
Topic 1: Regulatory Submissions5%- Compliance for clinical data reporting
- ICH and FDA guidelines
Topic 2: Clinical Trials Data Structures10%- Define.xml and dataset specifications
- Clinical domain structures
- CDISC standards: SDTM, ADaM
Topic 3: Macro Programming for Clinical Trials15%- Macro variables and parameters
- Debugging macros
- Create and call macros
Topic 4: Report Clinical Trials Results10%- Produce tables, listings, and figures
- PROC REPORT and PROC PRINT
Topic 5: Apply Statistical Procedures for Clinical Trials15%- PROC MEANS, FREQ, TABULATE
- Basic statistical analysis for clinical data
Topic 6: Manage Clinical Trials Data5%- Use SQL and dictionary tables
- Clean, merge, and subset data
- Access and explore clinical datasets
Topic 7: Transform or Summarize Clinical Trials Data15%- Derive variables and study days
- Data step manipulation
- Aggregation and transposition
Topic 8: Validate Clinical Trial Data Reporting20%- Programming validation techniques
- Use PROC COMPARE and log review
- Validation principles
Topic 9: Clinical Trials Process5%- Derive programming requirements from protocol and CRF
- Clinical trial lifecycle and protocol

SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. In a Statistical Analysis Plan (SAP) the following statement is written:
To test the association between the pain intensity reported by the patient and the treatment the patient has been administered, a Cochran-Mantel-Haenszel test will be performed adjusting for the country of the patient's investigational site.
The following variables and levels are used:
- Pain intensity (PAIN): "No pain", "Mild pain", "Moderate pain", "Severe pain", "Most severe pain"
- Treatment group (TREAT): "Placebo", "Drug A", "Drug B"
- Country (COUNTRY): Eight different values.
The following program is written to perform this analysis:
proc freq data=pain;
by COUNTRY;
tables PAIN * TREAT / cmh;
run;
This code does not produce the analysis requested by the SAP.
What is wrong with this code?

A) The variables PAIN and TREAT should be on the BY statement, and the variable COUNTRY should be on the TABLES statement.
B) The option CMH should be on the PROC FREQ statement instead of on the TABLES statement.
C) The variable COUNTRY should be on the TABLES statement instead of the BY statement.
D) The variable PAIN should be on the BY statement along with the variable COUNTRY.


2. Given the following output from the TTEST Procedure: Variable:

What is the t-test p-value?

A) <.0001
B) 0.3121
C) 37.49
D) 0.2041


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


4. Given the following partial output data set:

Which code was used to create AGECAT?

A) if age <18 then AGECAT=1; else if 18<=AGE<=40 then AGECAT=2; else AGECAT=3;
B) if age <18 then AGECAT=1; if 18<=AGE<=40 then AGECAT=2; else AGECAT=3;
C) if age <=18 then do AGECAT=1; else if 18<AGE<=40 then do AGECAT=2; else do AGECAT=3;
D) if age <=18 then AGECAT=1; else if 18<AGE<=40 then AGECAT=2; else AGECAT=3;


5. The following SAS program is submitted:

You want to store all calculated means and standard deviations in one SAS data set.
Which statement must be added to the program?

A) ods output mean=m1 m2 std=s1 s2;
B) ods output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
C) output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
D) output mean std;


Solutions:

Question # 1
Answer: C
Question # 2
Answer: A
Question # 3
Answer: D
Question # 4
Answer: D
Question # 5
Answer: C

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