eTMF Planning & Implementation

Developed by
Sholeh Ehdaivand

President & CEO

LMK Clinical Research Consulting

The Essential Workbook for eTMF Planning & Implementation

30+ essential questions for transitioning to an eTMF

This checklist has been designed as a self-guided preparation workbook to help your company plan a successful eTMF implementation. The workbook includes over 30 pre-loaded questions that will guide you through the key points to consider when you go through your planning phases and as you begin to implement.


In the workbook, we cover the following topics:

  • Subscription
  • eTMF Setup
  • Quality Control
  • Equipment
  • Implementation
  • Metrics
  • Configuration
  • Support
  • Migration
  • Integration/Interoperability