Advanced Post Graduate Diploma in Clinical Data Management

Module 1 (Theory)
• Introduction to Data Management
• Study Set Up
• CRF Design Considerations
• Data Entry, Remote Data Entry
• Identifying and Managing Discrepancies
• Medical Coding
• Database Closure
• Clinical Database & Types
• Data Management Plan
• Electronic Data Capture
• Tracking CRF Data
• Managing Lab Data
• Collecting Adverse Event Data
• Creating Reports and Transferring Data
• Enterprise Clinical Data Management Tools Module I1 (Practical)
• Study set-up
• Introduction to Clinical Database
• Documents, guidelines used in CDM
• Data Entry
• Data Review/Data Validation, Query Management
• Database QC
• CRF Design (Introduction)
• Database Design (Introduction)
• Edit Check & Edit Check Testing
• UAT (User Acceptance Testing)
• SOPs
• Quality Assurance, Audits Module I (Theory) BASICS OF BIOSTATISTICS
• Introduction to Research and Statistics/Descriptive Statistics/Probability/Probability
• Distributions
• Sampling Distributions/Statistical Inference
• Correlation and Regression
• Choosing Statistical Tests/ T-Test, Chi-Square Test, ANOVA, etc
• Analysis of Categorical Data and Non Parametric Tests
• Introduction to Statistical Software's

Module II (Practical)

SAS PROGRAMMING
• Setting Started with SAS
• Components of SAS
• Reading various types of Raw data
• Working with SAS Datasets
• Working with SAS Dates
• Combining datasets
• Working with SAS Arrays
• Proc SQL
• SAS Macro Language
• Basic Statistical Procedures

CLINICAL DATA ANALYSIS AND REPORTING USING SAS SOFTWARE
• Introduction to Clinical Trials
• Understanding and Reviewing Statistical Analysis Plan
• Annotating the Mock Tables
• Creating Dataset Specifications
• Creating Analysis Datasets
• Creating Tables/Listings/Figures