SAS course Beginner level by IICRT - International Institute for Clinical Research and Training

Clinical Research Essential
•History of clinical research
•Clinical Research and It’s types phases
•Clinical Research – Study Design
•Trial Process
•Regulatory body Process
Global Regulatory Compliance
•Regulatory Requirements & it’s body Process
•Good Clinical Practice (GCP)
•Good Clinical Data Management Practice
•21 CFR Part 11: Electronic Records and Signature
•CDISC Introduction
•Computer System Validation
Biostatistics for Clinical Trials
•Introduction to Biostatistics – Scope & Limitation
•Epidemiological Study design- Descriptive, Analytical
and Experimental
•Epidemiological Measure.
•Statistical Analysis Plan
Clinical Trial Programming
•SAS programming tools & process.
•Understanding SAS syntax.
•Understanding SAS data & libraries.
•Importing external data into SAS.
•Data Manipulation Techniques.
•Combining and merging datasets.
•Enhancing reports with titles, footnotes, and labels
•Creating frequency reports
•Creating summary statistics reports
•Exporting data & reports
•Introduction to Macro Programming
•Macro Variables, Definition, Macro Statement
•Data Step and SQL Interfaces for Macro Program
•Advance Macro Programming Technique
•Creating Detail and summary report using REPORT and
TABULATE Procedure
•Output delivery system
•Introduction to ANOVA, Regression and Logistic
Regression
•More complex Linear model
•GLM and TTEST PROCEDURE
CDISC Essentials
•What is CDISC and Why Standards?
•Available CDISC Standards and models
•How SAS supports CDISC Model
•FDA – Submission Process.