- Duration: 10 weeks
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
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