What is an eTMF?

The electronic Trial Master File (eTMF) is an application which leverages software and server technology to guide and assist the setup, collection, storage, tracking and archival of essential clinical study documents.

The Trial Master File (TMF) is a structured collection of documents for a clinical trial to show evidence of regulatory compliance, allowing the conduct and quality of data collection to be evaluated. TMF contains study level, country level and site level documents, and those documents are collected at multiple points during the study (e.g. startup to study close). A related feature set, the electronic Investigator Site File (eISF) portal, can work in conjunction with your eTMF to facilitate document exchange between sponsor/CRO and sites.

Does my study need an eTMF?

The TMF is considered essential for Good Clinical Practice (GCP), and GCP is recognized as a requirement by regulatory agencies such as the FDA. An electronic system is not required but holds many benefits.

 
SimpleTrials CTMS Document Tracking Feature

The Benefits of eTMF

1. Setup Once, Reuse Many Times
Having a TMF skeleton that reflects your study design and meets your SOPs is a great way to facilitate document collection for your clinical trials. An eTMF can provide the tools to setup that skeleton structure, using a familiar tree-folder structure. Templates can be used to automate the build out of site regulatory packets, and the entire structure can be reused for future studies.

2. Remote Collaboration & Collection
Harness the benefits of web-based systems to allow your distributed study team to collaborate on the full life cycle of TMF management, from setup to archival. Documents can be uploaded by trusted study stakeholders from any location, as well as email attachment. An integrated eISF portal can minimize email-based and on-site collection of documents, by allowing sites to download and upload essential documents directly from the system.

3. Secure Storage & Archival
Remember the days of fire rated TMF file cabinets full of hard copy documents?  Leave that behind with electronic files in the eTMF.  Documents can be stored in a secure, reliable, redundant manner, while providing convenient access to your team.

4. Ease the Tracking Burden
Our team has experienced first-hand the challenges with tracking essential documents, such as those required for site activation.  This burden can grow exponentially as your clinical trial programs expand and progress.  Having a system that gives you real-time transparency into your document collection progress, and quickly identifies which documents are missing, can allow your team to quickly fill those gaps and move on.

5. Standards, Compliance & 21 CFR Part 11
eTMF provides built-in controls and features for compliance, such as an audit trail, user account controls, archival policy and electronic signatures.  Further, quality control workflows can assist with accurate and complete collection of documents. eTMF typically supports standards and conventions, such as the DIA Reference Model, making the adoption and adherence easier for your team.

Common eTMF Features

  • Folder based organization and navigation for your TMF structure

  • Built-in reference model support, e.g. DIA Reference Model v3.2

  • Template and packet definitions for countries and sites

  • Auto-generation of study, country and site level folders, based on the reference model or customized template

  • Electronic document exchange and collection via eISF portal (Investigator Site File), direct upload or email attachment

  • Document metadata management, including expiration tracking and alerts

  • Quality control workflows

  • Integration with related systems, like CTMS

  • Archival and download of TMF documents as a zip file

  • Dashboards for visualization of collection and performance metrics

Choosing the Right eTMF

Here are some of the common considerations when reviewing eclinical systems and making a selection of the right electronic trial master file solution to fit your needs:

  1. Feature Set
    Workflows and pain points vary from team to team and from study to study. What are the must-have and nice-to-have features for your needs?

  2. Flexibility & Customization
    Can the eTMF mold to your practices and policies in terms of customizations to the TMF structure as well as custom tracking fields?

  3. Ease of Adoption, Ease of Use
    Do you need a system that your team can start using on day 1? Or, do you need to hire a dedicated administrator, or plan for a lengthy build out? How much training will your team need to use the system effectively?

  4. Integrated eISF - Investigator Site File
    An integrated eISF can facilitate document exchange with sites, including both download and upload of critical study documents and essential site documents.

  5. Validation & Compliance
    Do you plan to use the eTMF as the system of record for regulated documents?  If so, a validated system with controls for 21 part 11 will be critical. Does the system support an efficient quality control workflow, to ensure that collected documents are accurate and readable?

  6. Support
    Is it important that your document management team be supported by a help desk that understands clinical studies?  Do you want the option of professional services and dedicated support from your eTMF provider?

  7. Cost
    Are you looking for a system with transparent pricing, which can start small and scale up?  Is there an additional fee for adding studies to the eTMF? Is there a startup fee to get the workspace launched?  Is a multi-year agreement required?

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Compliance and eTMF

Here are some important considerations for Compliance with a eTMF, including support for 21 CFR Part 11:

  1. Audit Trail
    The eTMF should create a complete audit trail for all data changes made in the system, including who made the change, when, and the old and new values.

  2. Archival Policy
    When removing records from the eTMF (should be rare, but it happens), the eTMF should be archiving data rather than deleting the data.  The main difference is that archived data can be easily restored (deleted data may not) and more easily tracked for historic/audit purposes. Archival adds protection for user error or malicious attempts to remove data from the system.

  3. Electronic Signatures
    The eTMF should support electronic signatures for the steps in your workflow where data integrity and accountability is critical.  Electronic and digital signatures take many forms, and may be dependent on your document format (e.g. PDF).

  4. Account Controls
    The eTMF should require that users be authorized and authenticated to the system, with controls around password expiration, idle session expiration, and locking of inactive accounts.

Talk to our eTMF experts to see if SimpleTrials is the right fit for your team.