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SASInstitute A00-282 Exam Syllabus Topics:

SectionObjectives
Topic 1: Regulatory and Clinical Research Concepts- Clinical trial workflow
  • 1. Regulatory submission basics
    • 2. Study design fundamentals
      Topic 2: SAS Programming for Clinical Trials- Reporting and Analysis
      • 1. Statistical reporting with SAS procedures
        • 2. Listings, tables, and figures generation
          - Data Management
          • 1. Data cleaning and transformation
            • 2. Dataset merging and manipulation
              Topic 3: Clinical Trials Data Standards- CDISC Standards
              • 1. SDTM structure and implementation
                • 2. ADaM datasets and analysis-ready data

                  SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

                  Question 1

                  Which date is presented using an ISO-8601 format?

                  A. 19800117
                  B. 17/01/1980
                  C. 01/17/1980
                  D. 17JAN1980


                  Question 2

                  Where would you store a value collected on a case report form but not defined in an SDTM domain?

                  A. DM
                  B. SC
                  C. RELREC
                  D. SUPPQUAL


                  Question 3

                  Which statement will produce report output that can be opened in Microsoft Word?

                  A. ods rtf='report.rtf';
                  B. ods rtf file='report.rtf';
                  C. ods doc file='report.doc';
                  D. ods type='word' file='report.doc';


                  Question 4

                  What is the key to ensuring traceability across CDISC data sets and modes?

                  A. Establishing a clear path between an element and all of its immediate successors.
                  B. Creating a map for each variable to all of its related predecessors.
                  C. Including STDM variables used to derive ADaM variables in the ADaM data set.
                  D. Establishing a clear path between an element and all of its immediate predecessors.


                  Question 5

                  What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects

                  A. MedDRA
                  B. 21 CFR Part 11
                  C. Good Clinical Practices
                  D. WHODrug


                  Solutions:

                  Question 1
                  Answer: A
                  Question 2
                  Answer: D
                  Question 3
                  Answer: B
                  Question 4
                  Answer: C
                  Question 5
                  Answer: C

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