Article | June 23, 2022

Now In Effect: 3 Key Functions Your eTMF Needs To Meet New EMA Regulations

By Robert Toal, Director of Product Management, eTMF, IQVIA Technologies


The European Medicines Agency (EMA) has a stated goal in EU 536/2014 to foster innovation through a simpler clinical trial application process across Member States while increasing transparency of clinical trials and their results. It included the development of a new EU Portal and EU Database, collectively named the Clinical Trial Information System (CTIS), where clinical trial information is submitted for agency and public consumption. The source of data entered into the CTIS will frequently include content from electronic Trial Master File (eTMF) systems.

To achieve compliance, the regulation states:

“A clinical trial master file (TMF), containing relevant documentation to allow effective supervision (monitoring by the sponsor and inspection by Member States), should be kept by the sponsor and by the investigator. The clinical trial master file should be archived appropriately to allow for supervision after the clinical trial has ended.”

As EMA’s new regulation takes effect, let’s consider three key functions that your eTMF must have to achieve compliance and maintain organizational success.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.


Subscribe to Clinical Leader