Exam Name: Clinical Trials Programming Using SAS 9.4
Certification Provider: SASInstitute
Corresponding Certification: SAS Clinical Trials Programming
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Updated: Oct 03, 2026
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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 2: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
| Topic 3: Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Topic 4: Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Data step manipulation - Derive variables and study days |
| Topic 5: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 6: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Topic 7: Macro Programming for Clinical Trials | 15% | - Debugging macros - Macro variables and parameters - Create and call macros |
| Topic 8: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 9: Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
A report that you are working on will require the following header lines:
Which code adds the second line of the header "Adverse Events"?
- A. title2 'Adverse Events';
- B. header2 'Adverse Events';
- C. header2 = 'Adverse Events';
- D. title2 = 'Adverse Events';
Correct Answer: A 🗳️
Which CDISC standard is concerned with the development of simplified case report forms?
- A. Trial Design Model (TDM)
- B. Study Data Tabulation Model (SDTM)
- C. Operational Data Model (ODM)
- D. Clinical Data Acquisition Standards Harmonization (CDASH)
Correct Answer: D 🗳️
Given the data set RAWBP that is sorted by SUBJECT TEST WEEK:
Baseline is defined as the week 0 value. Your colleague provides the following SAS program to calculate change from baseline:
data bp;
set rawbp;
by subject test week;
retain baseline;
if first.subject then baseline = value;
if week > 0 then change = value - baseline;
run;
What does the code calculate as the change from baseline for systolic blood pressure (SBP) at week 3?
- A. -30
- B. -40
- C. 40
- D. 30
Correct Answer: D 🗳️
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;
Correct Answer: B 🗳️
In a study, inclusion criteria required patients be between 18 and 65. Patients will be analyzed in 2 age groups: group one is subjects who are under 36 years of age and group two is subjects who are 36 years of age or older.
Which statements properly assign age group, and writes an error message to the log for any patient with an out of range age value?
- A. select;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; when (36 <= age < 66) agegrp = 2; when (18 <= age < 66) agegrp = 1; end; - B. select;
when (18 <= age < 36) agegrp = 1;
when (36 <= age < 66) agegrp = 2;
otherwise put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; end; - C. select;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; when (age >= 36) agegrp = 2; when (age >= 18) agegrp = 1; otherwise; end; - D. select;
when (age >= 18) agegrp = 1;
when (age >= 36) agegrp = 2;
when (age >= 66) put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; end;
Correct Answer: B 🗳️
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