SAS Certified Clinical Trials Programmer using SAS 9

SAS Certified Clinical Trials Programmer using SAS 9

SAS Certified Clinical Trials Programmer using SAS 9

SAS Certified Clinical Trials Programmer using SAS 9 Syllabus

  • Clinical Trials Process
    o Describe the clinical research process (phases, key roles, key organizations).
    o Interpret a Statistical Analysis Plan.
    o Derive programming requirements from an SAP and an annotated Case Report Form.
    o Describe regulatory requirements (principles of 21 CFR Part 11, International Conference on Harmonization, Good Clinical Practices).
  • Clinical Trials Data Structures
    o Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
    o Identify key CDISC principals and terms.
    o Describe the structure and purpose of the CDISC SDTM data model.
    o Describe the structure and purpose of the CDISC ADaM data model.
    o Describe the contents and purpose of define.xml.
    * Import and Export Clinical Trials Data
    o Combine SAS data sets.
    o Use list input to read raw data files (csv or tab delimited files).
    o Efficiently import and subset SAS data sets.
    o Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT).
    o Create temporary and permanent SAS data sets.
    o Apply regulatory requirements to exported SAS data sets (RAS V5 requirements)
  • Manage Clinical Trials Data
    o Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).
    o Access Dictionary Tables using the SQL procedure.
    o Sort observations in a SAS data set.
    o Create and modify variable attributes using options and statements in the DATA step.
    o Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc)
  • Transform Clinical Trials Data
    o Process data using DO LOOPS.
    o Process data using SAS arrays.
    o Retain variables across observations.
    o Use assignment statements in the DATA step.
    o Apply categorization and windowing techniques to clinical trials data.
    o Use SAS functions to convert character data to numeric and vice versa.
    o Use SAS functions to manipulate character data, numeric data, and SAS date values.
    o Transpose SAS data sets.
    o Apply ‘observation carry forward techniques’ to clinical trials data (LOCF, BOCF, WOCF).
    o Calculate ‘change from baseline’ results.
    o Obtain counts of events in clinical trials
  • Apply Statistical Procedures for Clinical Trials
    o Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).
    o Use PROC FREQ to obtain p-values for categorical data (2×2 and NxP test for association).
    o Use PROC TTEST to obtain p-values for continuous data (one-sample, paired and two-sample t-tests).
    o Identify and describe SAS procedures used to perform ANOVA.
    o Create output data sets from statistical procedures.
    * Macro Programming for Clinical Trials
    o Create and use user-defined and automatic macro variables.
    o Automate programs by defining and calling macros.
    o Use system options to debug macros and display values of macro variables in the SAS log (MPRINT, SYMBOLGEN, MLOGIC, MACROGEN)
  • Report Clinical Trials Results
    o Use PROC REPORT to produce tables and listings for clinical trials reports.
    o Use ODS and global statements to produce and augment clinical trials reports.
    o Use PROC GPLOT to create graphs for clinical trials reports.
    o USD ODS Statistical Graphing to create graphs for clinical trials reports
  • Validate Clinical Trial Data Reporting
    o Explain the principles of programming validation in the clinical trial industry.
    o Utilize the log file to validate clinical trial data reporting.
    o Use programming techniques to validate clinical trial data reporting (PROC COMPARE, MSGLEVEL).
    o Identify and Resolve data, syntax and logic errors.

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