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SAS Clinical Programming Course Curriculum

BASE/SAS
Getting Started with the SAS System:
  • Accessing the SAS System
  • Navigating among the SAS programming windows
Getting Familiar with SAS Data Sets:
  • Explain the concept of a SAS data library
  • Differentiate between a permanent library and a temporary library
  • Investigate a SAS data library using the CONTENTS and COMPARE procedure
Programming with the DATA Step
  • Reading SAS data sets and creating variables
  • Executing statements conditionally using IF-THEN logic
Accessing Data
  • Use FORMATTED, LIST and COLUMN input to read raw data files
  • Use INFILE statement options to control processing when reading raw data files
Creating Data Structures
  • Create temporary and permanent SAS data sets
  • Create and manipulate SAS date values
Controlling Input and Output
  • Outputting multiple observations
  • Writing to multiple SAS data sets
Summarizing Data
  • Creating an accumulating total variable
  • Accumulating totals for a group of data
Reading and Writing Different Types of Data
  • Reading delimited raw data files
  • Controlling when a record loads
  • Reading hierarchical raw data files
Data Transformations
  • Manipulating character variables
  • Manipulating numeric variables
Managing Data
  • Investigate SAS data libraries using base SAS utility procedures
  • Sort observations in a SAS data set
  • Conditionally execute SAS statements
Combining SAS Data Sets
  • Using the SET statement to concatenate two or more SAS data sets
  • Using the RENAME= data set option to change the names of variables
Generating Reports
  • Generate list reports using the PRINT and REPORT procedures
  • Generate summary reports and frequency tables using base SAS procedures
Producing List Reports
  • Generate simple list reports using the PRINT procedure
  • Display selected columns and rows in a list report
Enhancing Output
  • Customizing report appearance
  • Formatting data values
  • Creating HTML reports
Producing Summary Reports
  • Creating one-way and two-way frequency tables using the FREQ procedure
  • Generate simple descriptive statistics using the MEANS procedure
Handling Errors
  • Identify and resolve programming logic errors
  • Recognize and correct syntax errors
  • Examine and resolve data errors
Accessing Data Using SQL
  • Generate detail reports by working with a single table or joining tables using PROC SQL and the appropriate options
  • Generate summary reports by working with a single table or joining tables using PROC SQL and the appropriate options
  • Access Dictionary Tables using the SQL procedure
SAS/Macro Processing
Overview of the Macro Facility
  • Understanding applications for the SAS macro language
  • Understanding how a SAS program is tokenized, compiled, and executed
Using Macro Variables
  • Using automatic macro variables
  • Creating macro variables
Macro Facility Interfaces
  • Creating macro variables during DATA step execution
  • Understanding how macro variables can be indirectly referenced
SAS/GRAPHS
Introduction to Graphics
  • Producing bar and pie charts
  • Enhancing output with titles, footnotes, color, and fonts

Procedures : Proc Plot, Proc Gplot, Proc Chart, Proc Gchart,proc device. Goptions

SAS/ODS
Creating XML Output with ODS
  • introduction to ODS XML
  • using ODS Markup to write XML files
Creating HTML and CSV Files with ODS Markup
  • creating HTML and related files
  • creating CSV and related files
Creating Other Files with ODS Markup
  • creating other output types
  • customizing output with targets
Using the SAS XML LIBNAME Engine to Create XML Files
  • introduction to the SAS XML LIBNAME Engine
  • using the SAS XML LIBNAME Engine to write XML files
Using the SAS XML LIBNAME Engine to Read XML Files
  • reading standard XML files
  • using the XMLMAP= option to read other files
  • XMLMap syntax
  • using SAS XML Mapper
ODS Tagsets and Events
  • how ODS creates markup output
  • understanding tagsets, events, and variables
  • PROC TEMPLATE tagset syntax
Customizing Tagsets with the TEMPLATE Procedure
  • modifying a tagset
  • inheriting from a parent tagset
  • creating your own tagset

SAS/Stat

Introduction to Statistics
  • examining data distributions
  • obtaining and interpreting sample statistics
Analysis of Variance
  • performing one-way ANOVA
  • performing multiple comparisons
  • performing two-way ANOVA with and without interactions
Regression
  • producing scatter plots
  • producing correlations
  • fitting a simple linear regression model
Regression Diagnostics
  • examining residuals
  • investigating influence and collinearity
Categorical Data Analysis
  • describing categorical data
  • producing frequency tables

Use PROC DATASETS to demonstrate advanced programming skills (e.g. renaming columns, displaying metadata, creating indexes, creating integrity constraints, creating audit trails)


Clinical SAS:

Clinical Trials Process
  • Describe the clinical research process (phases, key roles, and key organizations).
  • Interpret a Statistical Analysis Plan.
  • Derive programming requirements from an SAP and an annotated Case Report Form.
Clinical Trials Data Structures
  • Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.).
  • Identify key CDISC principals and terms.
Import and Export Clinical Trials Data
  • Combine SAS data sets.
  • Efficiently import and subset SAS data sets.
Manage Clinical Trials Data
  • Investigate SAS data libraries using base SAS utility procedures (PRINT, CONTENTS, FREQ).
  • Access DICTIONARY Tables using the SQL procedure.
Transform Clinical Trials Data
  • Process data using DO LOOPS.
  • Process data using SAS arrays.
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)
Macro Programming for Clinical Trials
  • Create and use user-defined and automatic macro variables.
  • Automate programs by defining and calling macros.
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
Introduction to Drug Development Process in Pharmaceutical Industry

Session Contents

Introduction to drug discovery and development process

  • Overview of highly regulated drug development process, from discovery to bringing a biopharmaceutical product to market
  • Understanding major phases (Phase I - IV) of clinical trials and clinical data management

Getting in depth knowledge about the functional group and working of CRO/Pharmaceutical industry and knowing in and out of guidelines pertaining to company involved in clinical trials.

Introduction to Clinical Trial Data

Session Contents

Clinical data preparation issues and different class of clinical data found in clinical trials

  • Learn to prepare and clean clinical trial data
  • Know how to categorize and summarize clinical data
Using SAS to Create Analysis Data sets

Session Contents

Learning tips and tricks to create and manage analysis data sets

  • Key concepts for creating and transforming analysis data sets (Using DATA steps and PROC TRANSPOSE)
  • Comparing Data sets using PROC COMPAR
Generate Customized Clinical Trials Tables, Listings and Graphs/Figures

Session Contents

Creating Tables and Listings

  • Using PROC TABULATE to create clinical trial tables
  • Using PROC REPORT to report clinical trials tables and listing

Generating Graphs and Plots using SAS/BASE, SAS STAT and SAS/GRAPH

  • Producing Bar and Pie charts using PROC GPLOT and PROC GCHART
  • Creating Box and Scatter Plot using PROC BOXPLOT, PROC GPLOT and PROC UNIVARIATE
  • Creating Kaplan-Meier Plot using PROC GPLOT or PROC LIFETEST