Clinical SAS Online Training (1)

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