What is an eTMF?
All there is to know about eTMF Clinical Trial Software. The Electronic Trial Master File (eTTF) is an application which uses software and server technologies to help guide and support the setup, collection, storing, tracking and archiving of essential trial documentation.
The Clinical Research Electronic Data Capture (cREDCap) TMF is a structured database of various types of documentation used by CROs and sponsors when conducting clinical trials. It allows investigators to submit their TMFs online, which helps streamline the process of submitting them.
Do I really want to spend $20 for an eTMF?
The TMF is an important tool for good clinical practice, and GCP is recognized by regulatory agencies such as FDA. However, an electronic system is not necessary.
The Benefits of eTMF
1.1. Create an eTMF templateOnce you've decided what documents you'll need to collect, create an eTMF template based on your SOPs. Use templates to automate the creation of the various regulatory packets needed for each visit. For example, if you're collecting consent forms, create one template for consent forms, another for medical records, and so forth.1.2. Automate the build out of siteIf you're creating a new trial, start with an empty eTMF template. Add folders, subfolders, and files as appropriate. When you add a file to the folder, make sure it matches the naming conventions for the type of data being collected (e.g., consent forms). Then, use the "Build" feature to populate the site with the appropriate documents.
2. Remote collaboration and collection harness the benefits of online systems to enable your distributed research team to collaborate on the entire lifecycle of TMF administration, from setup to archive. Your team can work together through a secure interface to create, edit, review and manage all aspects of TMF documentation and data. You'll also be able to share files securely via FTP, as well as attach them to emails. A single eISF portal allows researchers to access essential information about projects, such as project status and funding, without having to leave the office.
In addition to storing data securely, eTMFs provide easy retrieval of information via an intuitive interface. Information can be accessed quickly and easily through the eTMF’s user friendly interface. With the ability to store large amounts of data, users are able to retrieve any document they need, anytime they need them.
We've seen firsthand how burdensome it can be to track important documentation across multiple teams and locations. Our solution allows you to easily identify which files are missing and where they're located so you can get them back online faster.
Common eTMF Features
- Folder based organization and folder based navigational menus for your TMF structure.
- Built-in reference models, for example, the DIA Reference Model v 3.2
- Country/site specific templates and packets
- Generate study, country and site-level folders for each project automatically, using the predefined templates or customizing them according to the needs of specific projects.
- Electronic documents exchanged and collected via an electronic Investigator Site File (eISF) portal (investigator site file)
- Metadocument (or document) metadata includes things like expiration dates and alerts.
- Quality control workflows
- Integration with related systems, like CTMS
- Archive and download TMF documents as a.zip archive
- Dashboards for visualizing collections and performance metrics
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Choosing the Right eTMF
When considering electronic clinical trials solutions, here are some of the most important factors to consider:
- Feature set varies from one project to another. What are the must have and nice to have feature sets for your needs?
- Can the eTMF be customized to fit your practices and policies? And can it provide custom tracking features?
- Ease of adoption, ease of use, and how long it takes to get up and running.
- An integrated eISP (electronic ISP) can help you share important documents with sites, including both downloading and uploading of critical documents and essential site documents from your own computer.
- You should definitely consider using the eTMF as your primary document management solution. But if you're going to go ahead with that, then you need to select a validation and compliance solution that supports your needs. And you need to make sure that your chosen solution provides an efficient quality control workflow to ensure that your collection of electronic records is accurate and legible.
- It’s important that your document storage team has access to a help desk that understands the unique needs of clinical trials. You may need the ability to pay for professional service or dedicated support from your eTRM provider.
- Are you searching for a system with transparent pricing, which can begin small and expand outwards? Does the service charge an extra cost for every study added to the eTMFs? Is there a setup cost to get your workspace started? Is a multi-annual contract needed?
Compliance and eTMF
Here are some important things to consider when implementing an electronic transaction management system (eTM) including support for 21 CFR part 11:
- An audit trail must be created for every data modification in an eTMF.
- When removing records from the ETMF, the ETMF should archive the record instead of deleting the record. The main differences between archival and deletion are that archived records can be easily restored and more easily tracked for historical/auditing purposes. Archived records add security against errors due to human mistakes or malicious attempts to delete records.
- Electronic Signatures - eSignature technology allows you to sign documents electronically, which helps ensure data accuracy.
- User authentication should require authorization and authentication before allowing access to the system.