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

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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.

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