The 5 W’s of eTMF Planning

Written By Chris Johnson

As with most critical business processes, proper planning can be the difference between success and failure. The same can be said for Electronic Trial Master Files. 

The use of Electronic Trial Master File (eTMF) systems in the Life Sciences has been increasing rapidly over the past few years. The increase in eTMF use has often meant organizations have rushed into eTMF, not putting in place the vital processes that will deliver eTMF success. 

As an eTMF vendor, Sentinel Clinical Solutions helps life sciences organizations transition to eTMFs on a weekly basis. We are constantly reminding our clients of the change in mindset that is required as they transition to an eTMF, and that moving to an electronic system doesn't mean mimicking their  paper process. Meaningful eTMF planning at Sentinel Clinical Solutions hinges on 5 key pillars, these are shown below.

What: Expected artifacts

Who: Roles and responsibilities

When: Milestones, Events, and timeliness standards

Where: Systems that hold the authoritative source

Why: Processes and events

Take a look at what the 5 W's of eTMF Planning really mean in this great infographic we put together. If you find the infographic useful, remember to share it with your colleagues.

What - Expected Artifacts 

  • Remember that the primary purpose of TMF is to tell a story

  • Define what needs to be collected based on the assumption (not just ICH E6 guidelines)

  • Expected artifacts form the basis of system configuration for a study

  • Artifacts can be also data and not just documents

  • Search for a system that allows you to define your own standard based of study design

  • Pick out what is inspectable and in what state 

Who - Roles & Responsibilities 

  • Specify internal and external organizations and roles

  • Associate these to artifacts with the system

  • Inspector should be clear with who is responsible for what

When - Milestones, Events & Timeliness

  • Define different milestones at study, country & site level linked  with artifact

  • Look out for events and what information should be available in the TMF to support and document these events

  • Ensure you have a clear system for measuring and demonstrating timeliness - identify key dates that will be used 

  • Associate timeliness calculation method to artifacts

  • Ensure the system is able to calculate and show timeliness during an inspection

Where - Identifying Authoritative Source

  • Clearly identify which system holds the authoritative source for each artifact

  • If shadow copies are being stored in primary eTMF system then they should be clear in eTMF Plan

  • Ensure that placeholder are present for artifacts being maintained outside of the primary eTMF

  • Better to provide hyperlink where possible

  • Think of how you will integrate with 3rd party systems to present information in one place or determine how you will provide access to the information

Why - Processes & Events

  • Associate process or event which generates which artifact

  • Indicate where artifact is necessary or not 

  • The ideal system will allow the inspector to navigate within and across processes or from a specific event

  • Very Challenging to put in place - very different approach to the current way of presenting an eTMF

Chris Johnson