Clinical Data Management (CDM)
Master clinical trial data collection, validation, and regulatory compliance in healthcare research in just 4 weeks!
What You'll Learn
Course Curriculum
4-week intensive program covering everything you need to become a skilled Clinical Data Manager.
Week 1: Introduction to Clinical Research & CDM
10 lessons- Overview of Clinical Trials and Drug Development
- Roles and Responsibilities in Clinical Research
- Good Clinical Practice (GCP) Guidelines
- Introduction to Clinical Data Management (CDM)
- Data Management Plan (DMP) Basics
Week 2: Data Collection & eCRF Design
11 lessons- Case Report Form (CRF) Design Principles
- Electronic Data Capture (EDC) Systems Overview
- Annotated CRFs and Database Design
- Edit Checks Formulation and Testing
- User Acceptance Testing (UAT)
Week 3: Data Validation, Query Management & Coding
11 lessons- Data Entry and Data Cleaning Strategies
- Identifying Discrepancies and Generating Queries
- Query Resolution and Tracking
- Medical Coding Standards: MedDRA Overview
- Medication Coding using WHO Drug Dictionary (WHO-DD)
Week 4: Database Lock & Regulatory Compliance
10 lessons- Serious Adverse Event (SAE) Reconciliation
- Quality Control and Audits in CDM
- Pre-Lock and Database Lock Procedures
- Data Extraction, Transfer, and Archiving
- 21 CFR Part 11 and Regulatory Inspections
Projects You'll Build
Apply your knowledge with real-world scenarios that showcase your skills to employers.
Data Management Plan (DMP) Creation
Draft a comprehensive DMP for a mock clinical trial detailing data workflows.
eCRF Design & Validation
Design an annotated Case Report Form and formulate logical edit checks for an EDC system.
Query Management Simulation
Analyze a mock dataset to identify inconsistencies, generate queries, and resolve them.
Medical Coding Practice
Code adverse events and concomitant medications using MedDRA and WHO-DD standards.
Prerequisites
Basic Computer Skills
Comfortable using a computer and navigating healthcare software
Time Commitment
15-20 hours per week for optimal learning
No prior experience in clinical research required - we'll teach you everything from scratch!
Clinical Data Management (CDM)
Master clinical trial data collection, validation, and regulatory compliance in healthcare research.
This course includes:
- 42 hours of video content
- 4 hands-on projects
- Certificate of completion
- Lifetime access
- Career support