Workbook

eTMF Planning & Implementation

Developed by
Sholeh
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.

eTMF-Planning-Workbook

In the workbook, we cover the following topics:

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