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Clinical Trials Programming Using SAS 9 – Accelerated Version

Exam Content Guide

Below we provide a list of the objectives that will be tested on the exam.
For more specific details about each objective download the complete exam content guide.

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Clinical Trials Process

  • Describe the clinical research process (phases, key roles, key organizations).
  • Interpret a Statistical Analysis Plan.
  • Derive programming requirements from an SAP and an annotated Case Report Form.
  • Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).

Clinical Trials Data Structures

  • Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
  • Identify key CDISC principals and terms.
  • Describe the structure and purpose of the CDISC SDTM data model.
  • Describe the structure and purpose of the CDISC ADaM data model.
  • Describe the contents and purpose of define.xml.

Import and Export Clinical Trials Data

  • Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Manage Clinical Trials Data

  • Access DICTIONARY Tables using the SQL procedure.
  • Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc).

Transform Clinical Trials Data

  • Apply categorization and windowing techniques to clinical trials data.
  • Transpose SAS data sets.
  • Apply 'observation carry forward' techniques to clinical trials data (LOCF, BOCF, WOCF).
  • Calculate 'change from baseline' results.
  • Obtain counts of events in clinical trials.

Apply Statistical Procedures for Clinical Trials

  • Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
  • Use PROC FREQ to obtain p-values for categorical data (2x2 and NxP test for association).
  • Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
  • Create output data sets from statistical procedures.

Macro Programming for Clinical Trials

  • Create and use user-defined and automatic macro variables.
  • Automate programs by defining and calling macros.
  • Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN).

Report Clinical Trials Results

  • Use PROC REPORT to produce tables and listings for clinical trials reports.
  • Use ODS and global statements to produce and augment clinical trials reports.

Validate Clinical Trial Data Reporting

  • Explain the principles of programming validation in the clinical trial industry.
  • Utilize the log file to validate clinical trial data reporting.
  • Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
  • Identify and Resolve data, syntax and logic errors.

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