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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Debugging macros - Macro variables and parameters |
| Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Derive variables and study days - Aggregation and transposition |
| Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
| Clinical Trials Data Structures | 10% | - Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
You want 90% confidence limits for a binomial proportion from a one-way table with PROC FREQ.
Which option must you add to the TABLES statement?
- A. BINOMIAL
- B. BINOMIAL ALPHA=0.1
- C. BINOMIAL ALPHA=0.9
- D. BINOMIAL ALPHA=90
Correct Answer: B 🗳️
Review the following procedure code:
proc ttest data=DATA1;
class GROUPVAR1;
var VAR1;
run;
Which variable is most appropriate to be analyzed as variable VAR1?
- A. Systolic blood pressure, with possible values of "<120", "120 - 139", "140 - 159", "160 - 179", and
"180+" - B. Age, with possible values of any integer between and including 18 and 65
- C. Number of infections, with possible values of 0, 1, or 2
- D. Treatment, with possible values of "Placebo" or "Active"
Correct Answer: B 🗳️
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 after race / page;
- C. break race / page;
- D. break page / race;
Correct Answer: B 🗳️
What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects
- A. 21 CFR Part 11
- B. MedDRA
- C. WHODrug
- D. Good Clinical Practices
Correct Answer: D 🗳️
This question will ask you to provide a line of missing code.
Given the dataset RAWBP that is sorted by SUBJECT TEST WEEK:
Which statement must be added to the program to calculate relative change in percent (percent change) from baseline?
- A. pct_chg = ((value - baseline) /value)*100;
- B. pct_chg = ((baseline - value) /value)*100;
- C. pct_chg = ((value - baseline) /baseline)*100;
- D. pct_chg = ((baseline - value) /baseline)*100;
Correct Answer: C 🗳️
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