Validates your ability to apply SAS® programming skills to clinical trials data by Epoch Research Institute (http://epochresearchinstitute.com)

SAS^® Certified Clinical Trials Programmer Using SAS^®9

Validates your ability to apply SAS^® programming skills to clinical trials data:

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

•          Combine SAS data sets.
•          Efficiently import and subset SAS data sets.
•          Access data in an Excel workbook (LIBNAME and PROC IMPORT/EXPORT).
•          Create temporary and permanent SAS data sets.
•          Apply regulatory requirements to exported SAS data sets (SAS V5 requirements).

Manage Clinical Trials Data

•          Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).
•          Access DICTIONARY Tables using the SQL procedure.
•          Sort observations in a SAS data set.
•          Create and modify variable attributes using options and statements in the DATA step.
•          Examine and explore clinical trials input data (find outliers, missing vs. zero values, etc). 

Transform Clinical Trials Data

•         Process data using DO LOOPS.
•          Retain variables across observations.
•          Use assignment statements in the DATA step.
•          Apply categorization and windowing techniques to clinical trials data.
•          Use SAS functions to convert character data to numeric and vice versa.
•          Use SAS functions to manipulate character data, numeric data, and SAS date values.
•          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.

                              

Clinical SAS Programmer -EpochSASTraining

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