What is eTMF – electronic Trial Master File Software?

WHAT IS AN ELECTRONIC TRIAL MASTER FILE (eTMF)?


An electronic master file or eTMF is a Trial Master File in electronic or digital format. It is a way of digitally capturing, managing, sharing and storing those essential documents and content from a clinical trial.

To understand further, let’s first describe what a Trial Master File or TMF is. Every organization, typically a pharmaceutical company or a biotech company, involved in a regulated clinical trial must comply with government regulatory requirements surrounding those clinical trials. One of the key criteria to fulfill regulatory compliance is to maintain and store certain essential documents related to that clinical trial. Essentially, a Trial Master File is a set of essential documents and content that shows how a clinical trial was conducted, managed and followed regulatory requirements. These essential documents allow for the evaluation of the conduct and quality of the clinical trial.

Wikipedia describes it further, “a trial master file contains essential documents for a clinical trial that may be subject to regulatory agency oversight. In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF.”

 

ELECTRONIC TRIAL MASTER FILE (eTMF)

As stated above, an electronic master file or eTMF is a Trial Master File in electronic or digital format. It is a way of digitally capturing, managing, sharing and storing those essential documents and content from a clinical trial.

Wikipedia further describes an eTMF as: “An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format. It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies. The term eTMF encompasses strategies, methods and tools used throughout the lifecycle of the clinical trial regulated content.”

 

To continue reading this article, please make your way to our sister site ComplyDocs where further information includes:

  • THE CASE FOR eTMF
  • WHAT ARE THE REQUIREMENTS OF AN eTMF?
  • KEY BENEFITS OF eTMF SOFTWARE
  • GROWTH OF THE eTMF MARKET

 

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