Drug Development
- Introduction to Clinical Trials and Phases of Trials
- Ethical Considerations in Clinical Trials – ICH GCP, 21 CFR Part 11, E9
- Key Documents in Clinical Trials – ICF, Protocol, Case Report Form (CRF), SAP
- Understanding Various Study Designs
- Understanding Different Modules of Clinical Data – Drug Exposure, Safety, and Efficacy Data
- Understanding SAP and TFL Shells
BASE SAS
Introduction
- The SAS System
- SAS Processing
- DATA Step Processing
- SAS System Options
Syntax
- Words and Names
- Variables
- Data Types
- SAS Expressions
- SAS Constants
- Operators
- Dates and Times
Accessing Data
- SAS Libraries
- SAS Data Sets
- Raw Data
- Input Statement
- Set Statement
- Using Multiple Datasets with the OUTPUT Statement
- Dataset Options
- KEEP, DROP, and RENAME Statements
Manipulating Data
- Automatic Variables
- Grouping Data
- PDV (Program Data Vector)
- Conditional Statements (IF, IF-THEN, IF-THEN-ELSE)
- Subsetting Data (WHERE, IF)
- Combining Data – All Dataset Operations
- RETAIN Statement – Creating Baseline Values
- Interleaving Concept – All Dataset Operations
- DO Loops (DO, DO-WHILE, DO-UNTIL) – Performing Operations Across Multiple Treatments
SAS Functions
- Date and Time Functions
- Character Functions
- Numeric Functions
Dataset Debugging
- Understanding Dataset Execution
- Understanding Types of Errors
- Reading the SAS Log and Interpreting SAS Messages
SAS Procedures
- Sorting Data – PROC SORT
- Frequency Procedure – PROC FREQ
- Summary Statistics – PROC MEANS, PROC SUMMARY, PROC UNIVARIATE
- Printing Data – PROC PRINT
- Reporting Data – PROC REPORT
- Summary Reports – PROC TABULATE
- Redirecting Log and Output – PROC PRINTTO
- Transposing Data – PROC TRANSPOSE
- Dataset Metadata – PROC CONTENTS, PROC DATASETS
- Comparing Datasets – PROC COMPARE
- Importing and Exporting Data – PROC IMPORT & PROC EXPORT
- Creating Portable Datasets – PROC COPY & PROC CIMPORT (Creating XPTs for Data Transfers)
Graphical Visualization
- PROC PLOT
- PROC GPLOT
- PROC GCHART
ODS Concepts
- ODS Statements
- ODS Options
- PROC TEMPLATE
SAS SQL
- Introduction to the SQL Procedure
- Retrieving Data from a Single Table
- Retrieving Data from Multiple Tables
- Creating and Updating Tables
- Programming with SQL
SAS Macros
- Introduction to the Macro Facility
- Variables
- Macro Processing
- Scope of Macro Variables
- Debugging Macros
- Macro Expressions
- Macro Quoting
- Interfaces with the Macro Facility
- Storing and Reusing Macros
Clinical Results (TLFs) Using SAS
Summary Tables
- Creating a Demographic Summary Table
- Creating a Disposition Table
- Adverse Event Summary Table
- Lab Summary Table
- Vitals Summary Table
- Validating Outputs
Listings
Graphs
- Change from Baseline Tables
- Mean Change from Baseline Graphs
- Kaplan-Meier Plot
- Box Plot for Lab Results
Case Study
SDTM (Study Data Tabulation Model)
SDTM Concepts
- CDISC Overview and Standards
- SDTM Introduction and SDTM IG
- Explaining SDTM Controlled Terminology (Code List)
- Types of SDTM Variables and Core Values
- SDTM Domain Categorization and Importance
- SDTM Variable Categorization and Importance
- SDTM General Assumptions
- Events Class Domains
- Findings Class Domains
- Intervention Class Domains
- Trial Design Domains
- Special Purpose Domains
- Custom Domains
- Value-level Metadata
SDTM Hands-on
- SDTM Mapping Specification
- SDTM Annotation
- SDTM Domain Creation Using SAS Programming
- Validation Using Pinnacle 21*
Case Study
ADaM (Analysis Data Model)
ADaM Concepts
- Introduction and ADaM Key Principles
- Different ADaM Structures
- Analysis Dataset Metadata
- Analysis Parameter Value-level Metadata
- Analysis Results Metadata
ADaM Hands-on
- ADaM Mapping Specification
- TFL Shells Annotation
- Creating ADSL Using SAS
- Creating ADAE Using SAS
- Creating ADLB Using SAS
- Validation Using Pinnacle 21*
Case Study
Submitting Clinical Data
- Define.xml of SDTM and ADaM
