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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Programming validation techniques - Validation principles |
| Topic 2: Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Derive variables and study days - Data step manipulation |
| Topic 3: Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Topic 4: Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Clean, merge, and subset data - Access and explore clinical datasets |
| Topic 5: Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - Clinical domain structures - CDISC standards: SDTM, ADaM |
| Topic 6: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 7: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 8: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 9: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
1. 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 (18 <= age < 36) agegrp = 1;
when (36 <= age < 66) agegrp = 2;
otherwise put "ERROR: AGE OUT OF PROTOCOL SPECIFIED RANGE FOR " subject= age=; end;
B) 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;
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;
2. Given an existing work data set (DM), the following code is submitted:
A) MRECALL
B) MLOGIC
C) SYMBOLGEN
D) MPRINT
3. The following SAS program is submitted.
What result is displayed for the variable COUNT?
A) 1
B) 4
C) 3
D) 2
4. You are working on validating the ADSL data set which contains the variables subject, sex, age, birth date, baseline height, and baseline weight. These variables are brought in from SDTM, and you derive new variables baseline BMI (from baseline height and weight) and age categorization (from age).
You get the following in the SAS log:
To reconcile this difference, which variable values will be most helpful to provide to the production programmer?
A) SUBJID BLHT BLWT BLBMI
B) AGECAT1 BLBMI
C) SUBJID BLBMI
D) BLBMI
5. Which is NOT required in the ADSL data set?
A) AGEU
B) AGE
C) SITEID
D) FASFL
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: C | Question # 4 Answer: A | Question # 5 Answer: D |
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