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.