Clinical Data Management – Self Learning

The Course Modules are

1: Introduction to Clinical Research
Overview of clinical trials and phases (I–IV)
Role of clinical data management in drug development
Key stakeholders: Sponsor, CRO, Investigator, Regulatory Bodies
GCP (Good Clinical Practice) guidelines

2: Fundamentals of Clinical Data Management
Definition and objectives of CDM
CDM life cycle overview
Roles and responsibilities of a CDM professional
Regulatory bodies (FDA, EMA, ICH-GCP) and their impact on CDM

3: Clinical Trial Design and Protocol Review
Clinical trial protocol structure
Case Report Form (CRF) design principles
Data collection strategies (paper vs. electronic)
Importance of protocol adherence

4: Case Report Form (CRF) Design
CRF components and layout
Data fields, validations, and edit checks
CRF annotation and completion guidelines
Tools for CRF design (e.g., InDesign, XML templates)

5: Data Management Plan (DMP)
Purpose and structure of a DMP
Key components: database design, validation rules, timelines
Version control and amendments
Role of DMP in regulatory inspections

6: Electronic Data Capture (EDC) Systems
Overview of EDC systems (e.g., Medidata Rave, Oracle Clinical, REDCap)
User roles and access controls
Data entry and edit checks
Source Data Verification (SDV)

7: Data Validation and Cleaning
Data validation process and edit check development
Queries: raising, tracking, and resolving
Discrepancy management tools
Handling missing and inconsistent data

8: Coding Clinical Data
Introduction to medical coding in CDM
MedDRA (Medical Dictionary for Regulatory Activities)
WHO-DD (World Health Organization Drug Dictionary)
Coding AE/SAEs and concomitant medications

9: SAE Reconciliation and Quality Control
Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Reconciliation of safety and clinical databases
Data quality metrics and audits
Data cleaning reports and tools

10: Database Lock and Archival
Data review meetings and pre-lock activities
Database freeze vs. lock
Final reconciliation and archiving procedures
Regulatory submission readiness

11: Regulatory Guidelines & Compliance
ICH-GCP, 21 CFR Part 11 compliance
CDISC (Clinical Data Interchange Standards Consortium) standards
Audit trail and data traceability
Role of quality assurance in CDM

12: Career Preparation & Certification
Resume building and interview guidance
Mock interviews and case-based discussion
Overview of global CDM certifications (SCDM, CCRP)
Freelance, remote, and global job opportunities in CDM