eTMF MODULE

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