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Clinical Research Basics
Drug Development Process,
Clinical Research Terminology,
Departments and Roles in a CRO,
Overview of a typical Clinical Trial,
Understanding Clinical Trial Data,
FDA,
CDISC,
BASE/SAS
Introduction,
An Overview of the SAS System, SAS
Windows,
Introduction to SAS Programs,
SAS Naming Conventions,
SAS Data Libraries,
Creating SAS Datasets,
Assigning Variable Attributes,
Changing Variable attributes,
Understanding DATA Step Processing,
Types of errors, Debugging Techniques,
BASE/SAS:
Data Cleaning Techniques,
Defensive Programming Techniques,
Functions
Combining SAS Datasets ,
Procedures,
Understanding ODS (Output Delivery
System),
Conditional Processing ,
Arrays
Advanced SAS:
Introduction to Macros ,
Mechanics of Macro processing ,
Macro variables,
Macro Programs,
Macro functions,
Proc SQL,
PROC SQL Basics, Selecting Columns,
Using Inner Joins ,Using Outer Joins,
Joining Multiple Tables
Statistics:
Introduction to Statistics and Biostatistics,
What is P-Value?,
What is Hypothesis Testing?,
Using Proc Freq to analyze Categorical
Variables ,
Using Proc Univariate to analyze Continuous
Variables,
Using Proc Corr, Proc Reg ,
Using Proc Logistic,
Using Proc TTest (One-Sample,Two-sample),
Using Proc NPar1way for Non-Parametric
Analysis,
Using Proc Anova
SAS/GRAPH:
Introduction to Graphs and Figures,
Different statements used in creating Graphs,
Producing Bar and Pie Charts,
Producing Scattered Plots,
Line Plots,
Kaplan Meier Plots
Clinical Trial Project:
Understanding CRF(Case Report Form),
Protocol,
SAP (Statistical Analysis Plan),
Mocks (Mock Shells),
Specs (Specifications),
Classifying clinical trial data,
Understanding Issue log,
MOM (Minutes of Meeting),
SOP(Standard Operating Procedures),
SAS programming guidelines,
Study populations,
Clinical Trial Project:
 study day calculation,
 Windowing data,
 Transposing data,
 LOCF,
 Change from baseline,
 Creating Safety tables,
 Creating Efficacy tables,
 Creating Shift tables,
 Creating listing report,
 Validation and QC checks.
CDISC – SDTM Mapping:
CDISC Scope and Standards,
Overview of concepts,
SDTM-Implementation,
SDTM Standards,
Domain models, Domains and assumptions,
Special-Purpose Domains,
CRF versus SDTM Domains,
Mapping Process,
Define.xml

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SAS Clinical Online Training

  • 1. Clinical Research Basics Drug Development Process, Clinical Research Terminology, Departments and Roles in a CRO, Overview of a typical Clinical Trial, Understanding Clinical Trial Data, FDA, CDISC,
  • 2. BASE/SAS Introduction, An Overview of the SAS System, SAS Windows, Introduction to SAS Programs, SAS Naming Conventions, SAS Data Libraries, Creating SAS Datasets, Assigning Variable Attributes, Changing Variable attributes, Understanding DATA Step Processing, Types of errors, Debugging Techniques,
  • 3. BASE/SAS: Data Cleaning Techniques, Defensive Programming Techniques, Functions Combining SAS Datasets , Procedures, Understanding ODS (Output Delivery System), Conditional Processing , Arrays
  • 4. Advanced SAS: Introduction to Macros , Mechanics of Macro processing , Macro variables, Macro Programs, Macro functions, Proc SQL, PROC SQL Basics, Selecting Columns, Using Inner Joins ,Using Outer Joins, Joining Multiple Tables
  • 5. Statistics: Introduction to Statistics and Biostatistics, What is P-Value?, What is Hypothesis Testing?, Using Proc Freq to analyze Categorical Variables , Using Proc Univariate to analyze Continuous Variables, Using Proc Corr, Proc Reg , Using Proc Logistic, Using Proc TTest (One-Sample,Two-sample), Using Proc NPar1way for Non-Parametric Analysis, Using Proc Anova
  • 6. SAS/GRAPH: Introduction to Graphs and Figures, Different statements used in creating Graphs, Producing Bar and Pie Charts, Producing Scattered Plots, Line Plots, Kaplan Meier Plots
  • 7. Clinical Trial Project: Understanding CRF(Case Report Form), Protocol, SAP (Statistical Analysis Plan), Mocks (Mock Shells), Specs (Specifications), Classifying clinical trial data, Understanding Issue log, MOM (Minutes of Meeting), SOP(Standard Operating Procedures), SAS programming guidelines, Study populations,
  • 8. Clinical Trial Project:  study day calculation,  Windowing data,  Transposing data,  LOCF,  Change from baseline,  Creating Safety tables,  Creating Efficacy tables,  Creating Shift tables,  Creating listing report,  Validation and QC checks.
  • 9. CDISC – SDTM Mapping: CDISC Scope and Standards, Overview of concepts, SDTM-Implementation, SDTM Standards, Domain models, Domains and assumptions, Special-Purpose Domains, CRF versus SDTM Domains, Mapping Process, Define.xml