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.”

 

THE CASE FOR eTMF

Government regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have developed initiatives around the use of technology that could help both expedite the clinical trials approval processes and lower regulatory costs. The FDA created regulation CFR 21 Part 11 to address the use of electronic records, digital media and digital signatures in clinical trials. In Europe, the EMA also issued policies supporting the use of digital signatures in clinical trials. As a result of these technology policies, companies involved in clinical trials are able to move from a paper-based TMF process to an electronic TMF (eTMF), and still be in compliance with regulatory policies.

Why are companies seeking to transition from a manual paper-based systems to a more automated system through eTMF? Most paper-based industries and processes, even those that are highly regulated, have matured and benefited from some kind of digital transformation. Document Management software, CRM software, Health Care Records, and numerous other categories of software have all made workplace processes far more efficient. The pharmaceutical and biotech industry is no different. The managing of Clinical trial regulatory documents has historically been a paper-based process. It is laborious, costly and prone to errors. Providing a digital platform and strategy around the capture, management and reporting of regulatory documents will enable clinical trial stakeholders to be more productive, effective and reduce business risk throughout the regulatory compliance process.

 

WHAT ARE THE REQUIREMENTS OF AN eTMF?

Although most eTMF software vendors approach the functionality, design and specifications of their eTMF solution differently, they nevertheless share a common set of features. According to regulatory agencies, systems/software used to store electronic records or digital documents and content are generally subject to the following requirements: Digital content archiving, Security and Access controls, Change controls, Audit trails, and System validation. Most eTMF solutions vary in how they approach digitizing and managing the TMF, however, the above core requirements are almost always present.

 

KEY BENEFITS OF eTMF SOFTWARE

Capturing and managing clinical trial documents through paper-based or network-folder TMFs can be time-consuming, difficult to manage, and may produce costly errors that put your clinical trials at risk. Adopting an eTMF allows for real-time oversight and management of documents to ensure compliance and audit readiness throughout the trial. Some key benefits include:

  • Access, approve, share and manage clinical documents anytime from a web-based application
  • Improved quality of the TMF: digital solutions make fewer errors than manual/paper processes
  • Improves efficiency during the conduct of a trial
  • Reduce regulatory risk: documents/reports can be audit ready far quicker than paper systems
  • Shorter trial start-up and close-out time
  • Faster document searching and retrieval
  • Cost savings from increased filing efficiency, reducing paper and labor usage

 

eTMFs ARE GAINING WIDESPREAD ADOPTION

According to an eTMF report by Future Market Insights, the world wide eTMF market is expected to show exponential growth over the next decade. The report calculated a compound annual growth rate (CAGR) of 14.0% over the period of their forecast.

The continued growth of the global electronic trial master file (eTMF) market can be attributed to the growing number of clinical trials across the globe and an evolving technology maturity of pharmaceutical companies and CROs to web-based applications.

For a more detailed summary on the growth of the eTMF industry, please read our article summarizing some of the top reports published on the eTMF market.