What is an ETMF in pharma?

What is an eTMF?

TMF is stands for Trial Master File and eTMF stands for Electronic Trial Master File. Let’s understand What is an eTMF and TMF?

Definition of Trial Master File (TMF)

“TMF is known as a set of content that involves clinical trial of human or animals.”

Trail Master File (TMF) contains the essential documents related to the Clinical trial that is subjected to the regulatory agency. It allows both the conduct of a clinical trial and the quality data produced to be evaluated.

Definition of Electronic Trial Master File (eTMF)

“Electronic Trial Master File (eTMF) is one of the type of content management system application for the Clinical trial in pharmaceutical industry.”

ETMF is an electronic format of the TMF, that contains documents, images, data and other digital content that required to comply the regulatory requirements. The eTMF includes software and hardware that provides the management of clinical trial content.

The eTMF system includes, security and access control, storage, change control, system validation, audit trial and archiving of data.

In order to lower the physical data filling cost and to fast the approval process of clinical trial the eTMF was introduced by United State Food and Drug Administration (USFDA) and the European Medicines Agency (EMA).

What is an ETMF in pharma?

What is an eTMF?

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