CLINICAL SAS

Why Should You Take

Clinical SAS

SAS is widely used in clinical trial data analysis in pharmaceutical, biotech and clinical research companies. SAS programmers play an important role in clinical trial data analysis. In addition to doctors and clinicians who collect clinical trial data, the group conducting data analysis includes statisticians, clinical data managers (COMs) and SAS programmers. Statisticians provide the ideas and methods of the data analysis, clinical data managers manage the collected data and control the data quality. In between, SAS programmers implement the analysis methods on the collected data and provide the study summary tables, data listing and graphs to the statisticians and clinicians to write study report. SAS programmers work closely with statisticians and data managers. They provide the link between raw data and the analysis.

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COURSE CONTENT / TOPICS:

Module - 1   -   Base SAS certification module

INTRODUCTION OF SAS SOFTWARE.

  • Industries using SAS

  • Components of SAS System

  • Architecture of SAS system

  • Functionality of SAS System

  • Introduction of SAS windows

OUTPUT DELIVERY SYSTEM

  • Concepts of output delivery system

  • How ODS works and viewing output of ODS in different format

  • HTML, RTF, PDF etc.

PROCEDURES

  • Procedure Format

  • Procedure Contents

  • Procedure Options

  • Procedure Append

  • Procedure Compare

  • Procedure Transpose

  • Procedure Print

  • Procedure Import

  • Procedure Export

  • Procedure Datasets

  • Procedure Tabulate

  • Procedure Chart, Gchart, Gplot

  • Procedure Report.

WORKING IN THE SAS ENVIRONMENT

  • Functionality of SAS Windows
    Creating and managing SAS Libraries

  • Overview of SAS Data states

  • Types of Libraries

  • Storing files temporarily and permanently

  • Referencing SAS files

COMBINATION THE DATASET

  • One-o-one reading

  • One to many

  • Many to many

  • Concatenation

  • Interleaving

  • Match merge

ARRAY:

  • Definition of array

  • Example of array

GRAPHS

  • Introduction to graphics

  • Introduction to graphics

  • Types of Graphics (with latest models)

  • Defining procedure Graphics.

CREATION DATABASE FROM RAW DATA

  • Steps to create a SAS dataset

  • Creating SAS dataset using text file

  • Creating SAS dataset using text file with delimiters

  • Creating SAS dataset using structured text file

  • Creating SAS dataset using unstructured text file

  • Creating SAS dataset using Excel file

  • Creating SAS dataset using Access file

  • Creating SAS dataset using values inside the code

FUNCTIONS

  • Character function

  • Numerical function

  • Arithmetical function

  • Mathematical function

  • Date Function

Loops in SAS: Do Loops

  • Do Loop

  • Do While

  • Do Until

Module - 2   -   Advance SAS Topic

PROC Sql

  • Performing Queries Using PROC SQL

  • Performing Advanced Queries Using PROC SQL

  • Combining Tables Horizontally Using PROC SQL

  • Combining Tables Vertically Using PROC SQL

  • Creating and Managing Tables Using PROC SQL

  • Creating and Managing Indexes Using PROC SQL

MACRO

  • Create and use user-defined and automatic macro variables within the SAS Macro Language

  • %Let

  • %Call SYMPUT

  • %Macro %mend

  • Create the macro by Proc Sql

  • %INCLUDE

  • Automate programs by defining and calling macros using the SAS Macro Language

  • Understand the use of macro functions

Module - 3   -   SAS Clinical Programming

INTRODUCTION OF SAS AND CLINICAL RESEARCH

  • SAS role in Clinical Research

  • What is Clinical trial?

  • What is Protocol and role of Protocol in Clinical Research?

  • Which is playing main role in Clinical Research?

  • Clinical Trials Data Structures

  • Identify the classes of clinical trials data (demographic, lab, baseline, concomitant medication, etc.)

  • Identify key CDISC principals and terms

IMPLEMENT ADAM CONCEPT ON SAS USING LIVE PROJECT

Creating ADAM (Datasets) 4 Different types of ADAM Datasets

  • ADSL

  • ADAE

  • ADEF

  • ADtte

TRANSFORM CLINICAL TRIALS DATA

  • Apply categorical and windowing techniques to clinical trials data

  • Transpose SAS data sets

  • Apply ‘observation carry forward’ techniques to clinical trials data (LOCF, BOCF, WOCF)

  • Calculate ‘change from baseline’ results

  • Windowing concept

CDISC SDTM DATA MODEL

  • What is SDTM

  • Purpose of SDTM

  • Domain

  • Variables

  • Role Concept

  • Core Variable Concept

  • General Observation Classes

  • Controlled Terminology

  • SDTM Mapping Process

  • DESIGN AND IMPLEMENTATION

  • SAS Program for NON SDTM to SDTM

  • Implement SDTM concept on SAS using live project

  • Describe the contents and purpose of define.xml

STATISTIC AND REPORT CLINICAL TRIALS RESULTS

  • Use SAS procedures to obtain descriptive statistics for clinical trials data (FREQ, UNIVARIATE, MEANS, SUMMARY).

  • Create output data sets from statistical procedures

  • Using ODS with PROC REPORT and PROC TABULATE to generate nice looking tables and listings

  • Producing Bar and Pie charts using PROC GPLOT and PROC GCHART

CLINICAL PROJECT

  • 1 Project (SDTM)

  • 1 Project (ADAM)

  • 5 Project (TLF)

CDISC ADAM DATA MODEL

  • What is ADAM

  • Fundamental principles

  • Traceability

  • ADAM datasets workflow

  • ADAM Related Process

  • Data Metadata

  • Variable Metadata

  • Variable Value Level Metadata

  • Controlled Terminology/Code Lists

  • Core variables

  • The ADaM Standard

  • ADSL

  • BDS

BASIC STATISTIC

  • Data Exploration

  • Data Preparation

  • Summary Statistics

  • Summary Statistics - Central Tendency

  • Summary Statistics - Central Tendency

  • Introduction to Statistics - Descriptive Statistics

  • Introduction to Statistics -Samples and Populations

  • Hypothesis Testing

  • Concept of hypothesis testing

  • Chisq

  • Anova

SUPPORT

  • Study material: Notes and Books

  • Daily assignments with respect to chapter for hands on experience

  • Interview preparation

  • Resume preparation help

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