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