electronic trial master file (eTMF)

What is a Trial Master File?

Clinical trials help establish the safety and effectiveness of medical interventions in patients. A Trial Master File contains all the documents pertaining to a specific trial. This often includes the study protocol, management plan, investigator brochure, informed consent forms, monitoring reports, and much more.

What is an Electronic Trial Master File (eTMF)?

An Electronic Trial Master File (eTMF) is any software solution that enables storage and management of essential documents and data for clinical trials. A robust eTMF allows sponsors to not only quickly visualize clinical trial progress and manage study documents, but also abide by good clinical practices (GCP).

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Five Main Benefits of using an eTMF

Maximize Efficiency

Streamline the trial process by facilitating document filing in accordance with the latest reference model. By improving the searchability and traceability of study documents,...

Maximize Efficiency

Streamline the trial process by facilitating document filing in accordance with the latest reference model. By improving the searchability and traceability of study documents, clinical teams can save critical time and improve internal processes.

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Gather Insights

View planned and actual milestones at any given point during the study. eTMFs often offer reports and dashboards, which aid in identifying potential problems early on and tracking...

Gather Insights

View planned and actual milestones at any given point during the study. eTMFs often offer reports and dashboards, which aid in identifying potential problems early on and tracking trial progress.

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Enhance Collaboration

Sponsors, CROs, and site staff are seldom based in the same location. Teams spread across different time zones can leverage built-in tools such as workflows and document editors...

Enhance Collaboration

Sponsors, CROs, and site staff are seldom based in the same location. Teams spread across different time zones can leverage built-in tools such as workflows and document editors to collaborate both asynchronously and simultaneously. A centralized eTMF reduces reliance on multiple communication methods out of the system; instead, instructions and comments provided within the eTMF are considered the source of truth. These capabilities cut down on miscommunications and rework.

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Improve Inspection Readiness

Ensure documents are present and filed correctly in accordance with the latest regulations. If a sponsor has dozens of sites at various stages within the same trial, the... Read More

Improve Inspection Readiness

Ensure documents are present and filed correctly in accordance with the latest regulations. If a sponsor has dozens of sites at various stages within the same trial, the eTMF can be updated contemporaneously, which provides a clearer picture which documents are outstanding. Read Less

Control TMF Security

TMFs often contain sensitive information, some of which must be blinded for study personnel. eTMFs provide more advanced access permissions than traditional shared drives, which... Read More

Control TMF Security

TMFs often contain sensitive information, some of which must be blinded for study personnel. eTMFs provide more advanced access permissions than traditional shared drives, which protects patients and the integrity of the trial data. Read Less

Trial Master File (TMF) FAQs

Adopting an eTMF solution is no simple feat. We’ve compiled some frequently asked questions about eTMFs.

What is the tangible impact of an effective eTMF?

Which eTMF systems are popular?

What are important considerations when selecting an eTMF solution?

What is the tangible impact of an effective eTMF?

The benefits of a well-implemented eTMF span far beyond your organization’s clinical team. Consider the following scenarios:

Leadership plans to discuss highly anticipated trials during the quarterly town hall. The eTMF enables them to access trial information more readily.
Clinical Research Associates (CRAs) use eTMF to remotely access the ISF. By doing so, CRAs can shorten site visits and save department costs.
Legal needs to reference trial information that may be involved in litigation. Before the eTMF was implemented, files were often edited with little visibility into who made what change. Now, the eTMF System Administrator may place a hold on documents, ensuring no users are versioning or deleting it.

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Which eTMF systems are popular?

There are numerous eTMF vendors in the life sciences space, all of which generally provide reporting, workflow automation, and document version control. We’ve listed some of the most well-known software below.

Egnyte eTMF (Egnyte): Based on the CDISC TMF Reference Model. Allows for streamlined data collection across study sites and from other sources, such as eISF or CTMS.
eTMF Manager (MasterControl): Based on DIA Reference Model. eTMF Manager features external collaboration and task assignment that links accountable users to specific artifacts.
Rave eTMF (Medidata, Dassault Systemes): Allows ease of collaboration between sponsor, CRO, and site systems. Rave eTMF may be implemented in eight weeks and auto-populates content if integrated with Rave EDC and Rave CTMS.
Trial Interactive eTMF (TransPerfect): AI-powered eTMF that can be connected to TI’s 21 CFR Part 11 Compliant eClinical Platform. Unique features include document redaction, correspondence inbox, and a mobile application.
Vault eTMF (Veeva Systems): A cloud-based application, Vault eTMF has been adopted by 450+ organizations and can be integrated within Veeva’s Clinical Suite (EDC, CTMS, Study Startup, Site Connect). Vault eTMF allows customization across most features.

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What are important considerations when selecting an eTMF solution?

When deciding among eTMF vendors, gather the following information about your organization.

Business Requirements: eTMF solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if 21 CFR Part 11 eSignatures in the eTMF and email correspondence capture are must-haves, confirm that potential vendors will support those needs.
Budget: eTMFs should be viewed as an investment. Licensing, professional services, and subscription fees may be continuing costs that should be compared against your department's budget. Ask sales reps how pricing may change as you add more studies and scale the organization.
Timeline: Consider each vendor’s proposed implementation timeline against the time constraints of your company. If your first study site activation is in two months, narrow consideration down to vendors who can complete the project in that timeframe.
Complexity: Adopting an eTMF is an investment not only of money, but also of time and effort. Is the system easy to use? Can users be quickly onboarded and instructed on conducting processes within the eTMF? It is important to factor in your team’s adaptability and appetite for change when implementing a particular solution.

Several hands pointing to Tablet device and writing in notebooks

ProPharma's TMF Services & Approach

Thanks to eTMF, paper-based processes have become obsolete. For many sponsors, however, the current challenge lies in correctly using eTMFs to prevent avoidable delays and garner actionable insights. ProPharma's R&D Technology team understands the implications of selecting the right eTMF and excels in aligning your companies' needs with regulations and GxP system best practices. Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success. Our team has extensive experience in the following areas:

Service Category	How We Can Help
Strategy & Business Process Optimization	System Selection Roadmap Development
Clinical Operations	Staff Augmentation
Implementation Support	Project Management Configuration Data Governance and Migration Controlled Document Creation (SOPs and Job Aids) Training
Validation	Validation Coordination User Acceptance Test Scripts
Managed Services	Release Management System Optimization

ProPharma's eTMF Expertise

If you are interested in implementing or optimizing eTMF, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!

Speak to an eTMF Expert

Leveraging Veeva Vault’s TMF Bot & AI to Improve Quality and Consistency

July 19, 2023

The Trial Master File (TMF) allows an effective way to collect and manage study specific documents during a clinical trial. The TMF serves as a complete and accurate record of the trial's conduct, including the protocol, informed consent forms, study reports, and other important documents. With the...

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