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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, 
ICH, 
21 CRF Part 11 guidelines
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
 mangasubbu@gmail.com 
 +918686264989

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clinical sas 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, ICH, 21 CRF Part 11 guidelines
  • 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