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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: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 3: Clinical Trials Data Structures | 10% | - Clinical domain structures - CDISC standards: SDTM, ADaM - Define.xml and dataset specifications |
| Topic 4: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 5: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| 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% | - Macro variables and parameters - Create and call macros - Debugging macros |
| Topic 8: Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Programming validation techniques - Validation principles |
| Topic 9: Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Data step manipulation - Derive variables and study days |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
This question will ask you to provide a section of missing code.
Given the input SAS data set LABRAW:
Which DO LOOP will create the output SAS data set WORK.LAB_NEW?
- A. do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; end; output; end;
- B. do i=1 to 2; visit=i; date=dat{i}; result=num{i}; end; output;
- C. do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; output; end;
- D. do i=1 to 2; visit=i; date=dat{i}; result=num{i}; output; end;
Correct Answer: D 🗳️
Which two features are captured by the events general observation class of SDTM? (Choose two.)
- A. Planned protocol milestones
- B. Planned evaluations
- C. Investigational or therapeutic treatments
- D. Subject characteristics
Correct Answer: A,B 🗳️
The following question will ask you to provide a line of missing code. The following program is submitted to output observations from data set ONE that have more than one record per patient.
Please enter the line of code that will correctly complete the program. Note: Case is ignored. Do not add leading or trailing spaces to your answer.
- A. id;
PTON run; - B. BYSUBJID;
run; - C. BYSUBJID;
BYSUBJID; - D. BYSUBJID;
Correct Answer: D 🗳️
When writing a validation program using independent programming, which two actions conform to good programming practices?
(Choose two.)
- A. Ensure the production program has been run prior to compare.
- B. Copy statistical code directly from the production program.
- C. Copy statistical code directly from the SAP.
- D. Delete subjects from the production side that are causing differences with the validation data set.
Correct Answer: A,C 🗳️
Given the following complete dataset (WORK.TESTDM) with the variables USUBJID (character) and AGE (numeric):
The following code is executed:
proc sql;
select age into: age separated by ','
from testdm;
quit;
What is the value of the macro variable AGE?
- A. 17.1 17.7 4.4 3.8 6.3
- B. Blank, the code will not execute
- C. 17, 17, 4, 3, 6
- D. 17.1,17.7,4.4,3.8,6.3
Correct Answer: D 🗳️
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