Clinical Data Management

Our Courses

Clinical Data Management Course

Course Fee: $2500

Course Overview

A comprehensive course designed to provide in-depth knowledge of clinical research and clinical data management processes. The course covers principles, regulatory frameworks, and practical skills around clinical trial data using industry standard platforms like Open Clinica and REDCap.

WHO SHOULD JOIN?

Those aiming to start or advance careers in clinical research, pharma, biotechnology, or data management.

Course Modules

Module 1: Clinical Research & Clinical Data Management

Introduction to Clinical Research and Clinical Data Management
Different Phases of clinical trials
IND, NDA Applications
ICH-GCP Guidelines
Responsibilities of Clinical Trial Team
Protocol and Informed Consent Forms
Clinical Data Management Process and Life cycle
Data Management Plan
Case Report Forms, Types of CRFs
Designing of CRFs
CRF Annotation
Data Capture Methods and EDC
Data Entry – First pass and Second Pass Entry
Edit Check Specifications
Data Validation Procedures
Discrepancy Management
Data Clarification Forms (DCFs)
Database Locking and Freezing
Data Coding and Medical Dictionaries
SAE Reconciliation

Module 2: Open Clinica Database

Introduction to OC window
Subsystems in OC
Defining Programs and Projects
Defining Organization Units
Defining Regions
Defining Planned Studies
Easy Study Design
Creating Intervals
Creating Events
Creating Investigator, Site Records and Assignments
Creating Patient Positions and Assignments
Creating Questions
Creating Question Groups
Creating and Maintaining DVG’s
Creating DCM’s, DCI’s & DCI Books
Test a Study
Test Data Entry
Initial Login
Key Changes
First Pass Entry
Second Pass Entry
Comparison Reconciliation
Update
Browse
Patient Enrolment
Data Validation(Batch validation)
Discrepancy Management
Data Clarification Forms (DCFs)
Locking and Freezing

Module 3: REDCap Database

Creating Study in REDCap
Configuring Study in REDCap
Creating Events in REDCap
Creating Data Collection Instruments in REDCap
Add or Edit Records in REDCap
Record Status Dash Board in REDCap
Data Entry in REDCap
Data Validation in REDCap
Status Complete in REDCap
Accessing diff apps in REDCap
Data Analysis in REDCap
Report Generation in REDCap
Freeze & Locking in REDCap
Conclusion