SAS Clinickal Training

by Vibrant Technologies & Computers

Module

Title

Contents

Module 1:

Overview of SAS 9 Business Intelligence Platform and SAS Data Integration Study

Getting Started with SAS Understanding basic programming conventions Overview of the SAS system and types of SAS products used with different operating environment in Pharmaceutical Industry Introduction to SAS programs (Components, Characteristics, Layout, and Processing of SAS Programs) Exploring SAS Windowing Environment identifying the three primary SAS programming windows navigating SAS programming windows editing and executing SAS code saving and retrieving SAS code using the SAS Help facility Diagnosing SAS programs, log messages, and results of processing Getting Familiar with SAS Library and SAS Data Sets Explaining the concept of a SAS data library How SAS files are stored o Creating temporary or permanent libraries Understanding SAS data sets Overview of data sets Data types and size of SAS data sets Observations (Rows) and Variables (Columns) Missing values Rules for SAS names Methods for getting data into SAS Reading raw data (text, ASCII, CSV, Excel and flat files) into SAS and converting it to SAS dataset

Module 2:

Using SAS DATA steps

Programming with the DATA Step Creating SAS data set using DATA steps Creating and Modifying variables Associating and changing SAS variable attributes Executing statements conditionally (If-then-else) Dropping and Keeping variables in a dataset Understanding DATA step processing Combining SAS Data Sets Concatenating SAS data sets Merging and Interleaving SAS data sets Combining SAS data sets using additional features Excluding and Selecting variables from a dataset Working with SAS Data Using and Selecting SAS functions (PUT, INPUT, MIN, MAX, SUM, UPCASE, etc.) Working with SAS formats and informats Understanding SAS dates

Module 3:

Getting Acquainted with SAS PROCEDURES

Using SAS procedures Getting started with the PROC PRINT Sorting and Grouping observations using PROC SORT Creating user defined formats using PROC FORMAT Summarizing data using PROC MEANS Counting data with PROC FREQ Producing table using PROC TABULATE and PROC REPORT Transposing data with PROC TRANSPOSE Subsetting in Procedures using WHERE statement

Module 4:

Output Delivery System (ODS)

Concepts of Output Delivery System and it's usefulness in generating SAS outputs Select and trace procedure output for selective listings Using ODS to create HTML, PDF, RTF and PRINTER output Customizing ODS output using STYLE and PROC TEMPLATE option Generate summary tables using ODS RTF and PROC REPORT

Module 5:

Using SAS Macro Facility

Macro concepts Substituting Text with Macro variables Adding different parameters to Macros What are the advantages of the SAS Macro facility Writing data driven programs with CALL SYMPUT Understanding automatic and user-defined macro variables

Module 6:

Introduction to Drug Development Process in Pharmaceutical Industry

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 Learning rationale for each phases of drug development cycle and introducing role of SAS programmer in each phase. Food and Drug Administration (FDA) regulations and Guidance (21 CFR part 11, GCP, eCTD) Regulatory overview and approval process including IND/NDA to FDA

Module 7:

Introduction to Clinical Trial Data

Learn to prepare and clean clinical trial data Know how to categorize and summarize clinical data Studying and classifying different types of clinical trial data {Safety (ISS) and Efficacy (ISE) Data} Getting acquainted with new Clinical Data Interchange Standards Consortium (CDISC) implementation in categorizing clinical data Working with real pharmaceutical industry data (demographics, concomitant medication, medical history, laboratory data, adverse event, end point data, etc.)

Module 8:

Using SAS to Create Analysis Data sets

Key concepts for creating and transforming analysis data sets (Using DATA steps and PROC TRANSPOSE) Comparing Data sets using PROC COMPARE Learning about use of Medical Dictionaries (MedDRA and WHO Drug) in generating Adverse Event dataset Understanding and creating Time-to-Event, Change-from-Baseline, Critical variables data sets

Module 9:

Generate Customized Clinical Trials Tables, Listings and Graphs/Figures

Using PROC TABULATE to create clinical trial tables Using PROC REPORT to report clinical trials tables and listing Creating summaries of Adverse Event, Concomitant medication, Laboratory data using DATA steps and various SAS Procedures Creating Kaplan-Meier Survival Tables using PROC LIFETEST or PROC GPLOT Using ODS with PROC REPORT and PROC TABULATE to generate nice looking tables and listings