Considering switching from a paper trial master file to an electronic one? There’s no better time than now.
According to the 2022 TMF Reference Model Survey, 34% of organizations use a combination of paper and eTMF, and 49% retain all or some paper. Paper trial master files can be costly, time-consuming, and error-prone. If you are thinking of making a move from paper or a combination of paper and electronic, there are some things you’ll want to consider. Use this blog as a resource when making the transition.
eTMF Access Considerations
Rather than having only one location where physical trial binders are managed, a modern eTMF allows users (and partners) from all over the world access to your trial master file. Stored electronically, users can upload/review/approve documents. This is an integral component to advancing clinical trial capability as more companies solidify hybrid work models and as trials are being remotely implemented and monitored.
Ensuring Audit Trails & Compliance with an eTMF
Be inspection-ready at all times with an electronic trial master file where documents have audit trails and auditor-specific access can be provided to review documents. Auditors can be provided access remotely, reducing the need for in-office inspections. Add to that, modern eTMFs drive and support completeness, which can reduce findings during in the inspection.
How an eTMF increases Efficiency
Save time and budget by having everything available online. Quickly upload documents to binders and send them for review and approval with online signature vs. manual printing, signing, and mailing a physical paper binder.
eTMF Configuration Key Considerations
The Clinical Data Interchange Standards Consortium, known as CDISC, has a TMF Reference Model of recommended documents and templates for your trial. Some eTMF providers (including ArisGlobal) provide this configuration out of the box for customers to use. This can be configured exactly as needed for trials, or an organization can create its own customized template for storing documents within study binders. Documents can then be easily moved from one binder to another and re-classified online.
eTMF Milestone Tracking Requirements
Many eTMF providers offer milestone tracking as recommended by the TMF Reference Model. Users can easily see which documents have been uploaded for a required milestone and what may be missing. All are provided within the application, reducing the need for manual trackers and minimizing human error. Easily track timeliness related to document upload and document quality through embedded eTMF reporting tools.
eTMF Key Metric Requirements
The key metrics for any TMF are completeness, quality, and timeliness. This can be difficult to manage on paper as it requires manual tracking of documents, manual review, and no automatic audit trail. Leading eTMFs provide these metrics standard in the form of reporting, dashboards, or other tools, so users can easily and quickly find out the status of their TMF.
eTMF as a Single Source of Truth
Historically, documents are created outside the TMF system and later uploaded, classified, and used as a document repository with review capabilities. What if you could author your documents entirely inside the TMF? Leading eTMF partners like ArisGlobal are offering document authoring and collaboration tools within the application where a document can be authored alone or with other collaborators and then submitted for review and approval entirely in the application. This functionality makes the eTMF your single source of truth and not just a document repository but rather an efficient collaboration tool.
Contact the eTMF Experts at ArisGlobal
Looking to move from paper to electronic or upgrade your eTMF? Our team is here to help. Contact us, and don’t forget to download our helpful eTMF checklist.
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