Clinical Data Management Training Program

Overview

Week 1: Introduction to CDM

·         Clinical Trial Phases, Roles & Responsibilities

·         Regulatory Frameworks (ICH GCP, 21 CFR Part 11)

·         Clinical Data Types & Career Scope in CDM

Week 2: Data Standards & CDM Tools

·         CDASH, SDTM, Metadata Management

·         Introduction to CDMS and EDC

·         ALCOA+ Principles & Data Verification

Week 3: Compliance & Risk Management

·         ISO Standards, RBM, ePRO, Data Flow

·         CRF Design, Data Entry Processes

Week 4: Data Cleaning & Safety Management

·         Data Validation, SAE Reconciliation

·         Regulatory Updates & Interview Prep

Week 5: Advanced CDM & Digital Trials

·         eConsent, Remote Trials, Freelancing

·         CDM Documentation and LinkedIn Strategy

Week 6: Study Build in EDC/CDMS

·         Study Design, Data Import/Export

·         Mock Interviews and Career Pathways

Week 7: EDC/CDMS System Mastery

·         EDC Market Tools, Data Metrics, Study Setup

Week 8: Data Reporting & Monitoring

·         Extraction, Compliance, Audit Trails

Week 9: Monitoring & Study Navigation

·         Investigator Role, Participant Enrollment, eSignatures

Week 10: CDM Role-Based Training

·         Project Data Coordinator, CRA, Admin Roles

·         Resume Tailoring and Career Coaching

Week 11: Practical Study Implementation

·         Building and Monitoring EDC Studies

·         User Permissions and Study Monitoring

Week 12: Final Project & Graduation

·         Project Execution and Evaluation

·         Mock Interviews and Certification