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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Macro Programming for Clinical Trials | 15% | - Macro variables and parameters - Create and call macros - Debugging macros |
| Topic 2: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 3: Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Access and explore clinical datasets - Clean, merge, and subset data |
| Topic 4: Validate Clinical Trial Data Reporting | 20% | - Validation principles - Programming validation techniques - Use PROC COMPARE and log review |
| Topic 5: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 6: Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Derive variables and study days - Data step manipulation |
| Topic 7: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 8: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 9: Clinical Trials Data Structures | 10% | - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM - Clinical domain structures |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
Question 1
What is the main focus of Good Clinical Practices (GCP)?
A. standard analysis practices
B. standard monitoring practices
C. harmonized data collection
D. protection of subjects
Question 2
Identify the data structure with the following characteristics:
- Contains one or more records per subject, per analysis parameter, and per analysis timepoint.
- May be derived from findings, events, interventions and special-purpose SDTM domains, or other ADaM datasets.
- A record can represent an observed, derived, or imputed value required for analysis.
A. Subject Level Analysis Data Set (ADSL)
B. Event Level Analysis Data Set (ADAE)
C. Basic Data Structure (BDS)
D. General Data Structure (GDS)
Question 3
You want to calculate the p-value of Fisher's exact test for a 3x3 table.
Which option must you add to the TABLES statement of PROC FREQ?
A. CMH
B. EXPECTED
C. CHISQ
D. EXACT
Question 4
Given the SAS data set containing subject's phone numbers
What is the value of PHONE2 for subject 005?
A. 2156319494
B. (215) 6319494
C. (215) 631-9494
D. 631-9494
Question 5
What information can be found in the SAS Dictionary tables? There are two correct answer, Please select two correct answer.
A. values contained within a specified variable
B. datasets contained within a specified library
C. variables contained within a specified dataset
D. values contained within a specified format
Solutions:
| Question 1 Answer: D | Question 2 Answer: C | Question 3 Answer: D | Question 4 Answer: A | Question 5 Answer: B,C |
Ken 
Debby 
Penny 
Maurice 
Nat 
Lester 
Mirabelle 
Adelaide 
Webster 
Kay 
Jamie 
Jodie 
Myrna 
