This course provides hands-on training in eTMF setup, document management, compliance guidelines, and industry-standard tools like Veeva Vault. Through interactive learning, live demonstrations, and assessments, participants will master the eTMF reference model, document upload, reconciliation, review processes, and best practices for ensuring audit-ready clinical trial documentation. Key Learning Modules: 1. Introduction to Essential Documents ✔ Understanding Clinical Trial Documentation – Importance and regulatory requirements ✔ Regulatory Guidelines & Compliance – ICH GCP, FDA, EMA expectations 2. Introduction to the DIA eTMF Reference Model ✔ Overview of the DIA Model – Standardized eTMF framework for clinical trials ✔ Understanding eTMF Structure & Classification – Organizing essential documents 3. eTMF Management Plan ✔ Creating an Effective eTMF Plan – Key considerations and implementation strategies 4. eTMF Tools & Technology ✔ Overview of eTMF Platforms – Features and capabilities of digital TMF systems 5. eTMF Essential Document List (EDL) Creation ✔ Defining eTMF Document Requirements – Categorization and metadata assignment 6. eTMF Conduct & Maintenance ✔ Managing eTMF During Clinical Trials – Best practices for maintaining compliance 7. eTMF Review & Quality Control ✔ Ensuring Document Completeness & Accuracy – QC checklists and compliance audits 8. eTMF Reconciliation ✔ Identifying & Resolving Documentation Gaps – Strategies for audit preparedness 9. eTMF Document Upload ✔ Guidelines for Secure & Organized Uploading – Version control and metadata tagging 10. eTMF Document Completion Guidelines ✔ Ensuring Document Compliance & Finalization – Best practices for submission readiness 11. eTMF Demo – Veeva Vault (Industry-leading eTMF platform) ✔ Hands-on Demonstration – Uploading, reviewing, and managing documents in Veeva Vault 12. eTMF Demo – General Systems (Exploring other eTMF tools) ✔ Comparison of Different eTMF Systems – Features, usability, and regulatory compliance 13. eTMF Filing Guidelines ✔ Maintaining Organized & Audit-Ready eTMF – Folder structure, indexing, and retrieval 14. Assessments & Knowledge Check – Part 1 ✔ Evaluation of Key Concepts – Ensuring practical understanding of eTMF processes 15. Mock Interview Questions & Career Preparation ✔ Industry-Relevant Interview Questions – Preparing for eTMF-related job roles Who Should Attend? ✅ Clinical Research Professionals, Clinical Trial Associates & Project Managers ✅ Regulatory Affairs & Quality Assurance Professionals handling clinical documentation ✅ Pharmacovigilance & Drug Safety Associates managing eTMF records ✅ Medical Writers & Document Control Specialists in clinical trials ✅ Life Science & Healthcare Graduates seeking career opportunities in Clinical Research