Exam Name: Clinical Trials Programming Using SAS 9.4
Certification Provider: SASInstitute
Corresponding Certification: SAS Clinical Trials Programming
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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Topic 2: Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Create and call macros - Debugging macros |
| Topic 3: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Topic 4: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Use SQL and dictionary tables - Access and explore clinical datasets |
| Topic 5: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 6: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 7: Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
| Topic 8: Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Topic 9: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
The table below shows a subset of values of the variables LLTERM and HLTERM from a larger data set that is to be read into a DATA step.
Which subsetting IF statement could ensure that only records that have a missing value of LLTERM or a missing value of HLTERM are written to the resulting data set?
- A. if anyalpha(LLTERM, HLTERM) > 0;
- B. if nmiss(LLTERM, HLTERM) > 0;
- C. if missing(LLTERM, HLTERM) > 0;
- D. if cmiss(LLTERM, HLTERM) > 0;
Correct Answer: D 🗳️
The programmer runs a validation program of the SDTM DM domain which produces the following in the log in SAS:
What does the validator need to check?
- A. The labels of both the production and validation datasets.
- B. The formatted data values for SEX and AGE.
- C. The sort order of both the production and validation datasets.
- D. The internal data values for SEX and AGE.
Correct Answer: D 🗳️
The following SAS program is submitted:
Which alternative program creates an equivalent BASE_BP data set?
- A. proc sort data=VS (keep=usubjid vsstresn vstestcd)
out=BASE_BP (drop=vstestcd);
where vstestcd in('DIABP','SYSBP');
by usubjid;
run; - B. data BASE_BP;
set VS (keep=usubjid vsstresn);
if vstestcd in('DIABP','SYSBP');
run; - C. proc sort data=VS (keep=usubjid vsstresn vstestcd)
out=BASE_BP (drop=vstestcd);
by usubjid;
if vstestcd in('DIABP','SYSBP');
run; - D. data BASE_BP (keep=usubjid vsstresn vstestcd);
set VS (drop=vstestcd);
if vstestcd in('DIABP','SYSBP');
run;
Correct Answer: A 🗳️
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 out=WORK.RESULTS mean=m1 m2 std=s1 s2;
- B. ods output out=WORK.RESULTS mean=m1 m2 std=s1 s2;
- C. output mean std;
- D. ods output mean=m1 m2 std=s1 s2;
Correct Answer: A 🗳️
Vital Signs are a component of which SDTM class?
- A. Findings
- B. Special Purpose
- C. Events
- D. Interventions
Correct Answer: A 🗳️
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