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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 2: Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Topic 3: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 4: Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - Clinical domain structures - CDISC standards: SDTM, ADaM |
| Topic 5: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Derive variables and study days - Aggregation and transposition |
| Topic 6: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 7: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 8: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
| Topic 9: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Use PROC COMPARE and log review - Programming validation techniques |
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 the following information from the annotated CRF:
Which programming code will calculate the subjects' duration (days) of an AE?
A) AEDUR = AEENDTM - AESTTM + 1
B) AEDUR = AEENDT - AESTDT + 1
C) AEDUR = AESTDT - AEENDT + 1
D) AEDUR = AESTTM - AEENDTM + 1
3. Identify the CDISC model with the following characteristics:
XML-based content and format standard facilitates the archive and interchange of the metadata and data for clinical research provides an accurate audit trail that is 21 CRF Part II compliant
A) Operational Data Model (ODM)
B) Analysis Data Model (ADaM)
C) Study Data Tabulation Model (SDTM)
D) Trial Design Model (TDM)
4. Given the following vital signs data: Baseline is defined as the last non-missing value prior to Day 1.
What is the value for the change from baseline for Week 1 for Subject 2?
A) -11
B) -23
C) 23
D) 11
5. Given the following data set:
Which program was used to prepare the data for this PROC PRINT output?
A) proc sort data=one out=two nodupkey; by subjid; run;
B) proc sort data=one out=two nodupkey; by subjid trt;
C) proc sort data=one out=two nodup; by subjid; run;
D) proc sort data=one out=two; by subjid; run;
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: B | Question # 3 Answer: A | Question # 4 Answer: A | Question # 5 Answer: A |

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