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SASInstitute A00-282 Exam Syllabus Topics:

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

SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. Which validation technique involves two programmers writing separate programs to produce the same output, then comparing the result?

A) Independent Programming
B) Peer Review
C) Peer Matching
D) Identical Programming


2. Given the following data set:

Which type of clinical trials data is this?

A) Demographics
B) Vital Signs
C) Laboratory
D) Medical History


3. The PROC COMPARE code below is intended to validate the results from a PROC FREQ.
Both the ProdFreqData and ValFreqData data sets contain 10 observations of the variable Frequency.
No other variables are present in these data sets.
proc compare base = ProdFreqData
comp = ValFreqData
out = FreqDiffs
outbase outcomp outdif outnoeq
method = exact
noprint;
run;
After successfully executing this PROC COMPARE step, what is a possible reason for the FreqDiffs file to contain 30 records?

A) The variable labels of Frequency are different in the base and comparison data sets.
B) The variable types of Frequency are different in the base and comparison data sets.
C) The formatted values of Frequency are different in the base and comparison data sets.
D) The internal values of Frequency are different in the base and comparison data sets.


4. A statistical analysis plan asks you to create a table with the following counts of adverse events:
- the number adverse events in each system organ class (AESOC)
- within each level of system organ class, the number of adverse events with each preferred term (AEPT).
Which code produces the counts requested?

A) proc freq data=AE;
tables AESOC*AEPT;
run;
B) proc freq data=AE;
tables AESOC AEPT;
run;
C) proc freq data=AE;
tables AESOC (AEPT);
run;
D) proc freq data=AE:
tables AESOC, AEPT;
run;


5. In PROC REPORT, which usage creates a column in the report for each distinct formatted value of the variable listed in the DEFINE statement?

A) DISPLAY
B) GROUP
C) ACROSS
D) ANALYSIS


Solutions:

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

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