eTMF FAQ

Question: What is the offering? Please describe Trial Interactive?

Answer: For all participants in life sciences research, who want to store electronic Trial Master File documents during the execution of a clinical trial, Trial Interactive eTMF is an electronic Trial Master file that is part of the TransPerfect eClinical Suite. The eTMF does the following:
  • Streamlines the capture and management of trial content and documents throughout the study lifecycle,
  • Provides a fully collaborative, closed and pre-validated environment allowing users and document workflows to execute within the context of the trial and its investigative sites, and
  • Provides users with a common platform experience, unifying eTMF with other clinical trial systems.

Unlike other eTMFs that require users to send documents via email or fax or edit documents in different places, the Trial Interactive TI Collaborate allows users to upload, draft, review, and approve documents all within the eTMF. Users access all of these documents within the same environment, providing a common audit trial of changes and a "single source of truth" for the eTMF. Together with other Trial Interactive modules such as TI Study Start Up, TI Collaborate, TI Docs, Global Learn, eFeasibility, and TI Data Pool, the integrated systems speed study timelines and reduce costs while providing a comprehensive content management system throughout the study lifecycle.

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Question: What are some of the features of the eTMF?

Answer: The Trial Master File contains the documents that, individually and collectively, are essential for the evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. eTMF refers to the electronic maintenance and storage of the Trial Master File. A significant percentage of TMFs are still maintained entirely on paper. A small portion of sponsors have converted entirely to eTMF, and some sponsors use a combination of paper and eTMF. The benefits of the Trial Interactive eTMF include the following:
  • Master File functionality
    • Best practice approach to eTMF with flexible configurations available
    • Accelerated study and site start-up (e.g. facilitates gathering, storage of site-level documentation)
    • Built-in Audit support and quality check processes
  • Improved Compliance and Quality
    • Standard process for content submission with real-time addition of content
    • Accurate status reporting with eTMF Health Checks
    • Portfolio-wide reporting and benchmarking
    • Comprehensive services and staff augmentation available
  • Enhanced collaboration
    • Single, secure place for all clinical players to share documentation in a standardized, fully reportable system
    • Collects and organizes essential clinical documentation
  • Lower cost
    • Eliminates unnecessary downstream processing
    • Lower cost of ownership
    • Reduces logistical expense

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Question: What are some of the differentiators of the Trial Interactive eTMF?

Answer: Key standouts of Trial Interactive eTMF:

  • Part of Trial Interactive E-Clinical Platform
  • Supported by Comprehensive TransPerfect Life Sciences TMF Services (Paper and Digital) with Flexible Staff Augmentation
  • Fast and Flexible eTMF implementation
  • Out of the Box CTMS Integration
  • Both Standard and configurable TMF Reference Model Support
  • Adaptable QC and Audit Process
  • Simplified Coding and Auto-Naming
  • CRA Mobile App Available for site document capture
  • Corporate Directory Integration with Single Sign-On
  • IRB Integration and Submission Support
  • Built on Scalable, Proven Technology Platform
  • Flexible Rules and Placeholders for Required Documents by Country, Site
  • TMF Health Dashboards
  • Pre-Configured Migration, Scanning, Certification, and Upload Processes
  • CRA Reconciliation Support
  • Ad-Hoc and Standard Reporting
  • Comprehensive Audit Trail
  • Standard and Controlled Document Intake
  • Flexible Access Per User Across Studies
  • Controlled Document Authoring
  • Robust Search and Filter Capabilities
  • Roll Up and Multi Study Dashboard
  • Active Alerts and Notifications
  • Multi-Lingual and Translation Support Locally
  • Branded User Interface
  • 24x7 Help Desk Email and Phone
  • Email Correspondence and File Input
  • 21 CFR Part 11 Compliant Digital and Electronic Signatures
  • Comprehensive Validation Package
  • Supports Global Studies with World-Wide Accessibility and Translation Services from the #1 Translations Company

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Question: What is the maximum number of digits for file name and document title in the eTMF?

Answer: Document title is supported up to 400 characters, but when exporting files, the system truncates path + filename longer than 256 characters.

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Question: Are there file size limitations when importing documents to the eTMF?

Answer: When the documents are submitted via inbox submission, the maximum size of an email with the attachments is 100 MB. When the document is uploaded via the application, the max file size is 1GB, but this depends on the internet connection and session timeout of the user - the file must import before the session times out.

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Question: What browsers are supported for Trial Interactive?

Answer: Trial Interactive will be tested with all major browsers, including Chrome, Firefox, Safari, and Internet Explorer 8, 9, and up.

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Question: Will Trial Interactive work on the iPad or other tablets? Will Trial Interactive work on the iPhone?

Answer: In TI version 10, Trial Interactive will support fully responsive design. Trial Interactive is presently built upon a user interface framework that is designed to work on many screen sizes, including iPads, tablets, and mobile phone devices such as Android and iPhone. However, each of these must be carefully tested to ensure it will operate correctly with that specific screen size as well as the touch interface.

In addition, the myTI product is specifically designed for the iPhone, iPad, and Android Phones and Tablets for document capture and reconciliation at the site by the CRA.

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Question: Trial Interactive eTMF shows a rendition of the document instead of the original. Why?

Answer: Advantages of showing a rendition vs original document:

  • Streaming: only individual pages are sent to the browser, which means the image loads immediately.
  • Less Data Sent: Most produced images are smaller than the original document.
  • Image Quality: Resolution quality doesn't depend on the browser and installed PC hardware.
  • Since the agency (EMA) is using the same technology to review submissions, they are seeing the same rendition in TI.
  • At any time, users can choose to view the document in the native format, which will open the file in the locally installed viewer. PDFs will generally open in the browser, and other file types will download and attempt to open in the native viewer.

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Question: In 9.2, what are the supported conversions using to create the renditions?

Answer: The following file types are supported:

  • PDF - all versions
  • Images: JPEG, PNG, TIFF, GIF, BMP, JNG, PBM, PSD, EPS, PS, DCM (Format DICOM) and all formats supported by ImageMagick
  • Microsoft Office (97-2013): Word (.doc, .docx) , PowerPoint (.ppt, .pptx), Excel (.xls, .xlsx), WordML (.xml), Visio (.vsd)
  • Composite files: ZIP, EML, MSG
  • Others: TXT, OpenDocument (LibreOffice or OpenOffice)

–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––-Question: Are documents stored in Trial Interactive safe?

Answer: Extremely safe. All documents stored within the Trial Interactive system are encrypted in-place and in-transit in a private document store accessible only to the Trial Interactive application. Each encrypted document is duplicated into two separate locations, and the decryption keys are not stored with either Trial Interactive or the encrypted documents. This ensures that if any location is compromised, the documents cannot be read, and if Trial Interactive is compromised, the documents cannot be read. Only the compromising of both the hosting provider and the key storage puts any documentation at risk.

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Question: Can Trial Interactive connect to more than one IdP for Single Sign-On?

Answer: No. Suggestion, in this case, is to use a 3rd party service such as Okta, OneLogin, or PingIdentity.

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Question: Does Trial Interactive support a 'deep link' directly to a specific document is a room and index?

Answer: Yes.

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Question: How does Trial Interactive handle email correspondence?

Answer: What we do in 9.1:

  • Customers can send email messages to an eTMF email inbox for each room.
  • SSU also has an email Inbox, separate from the eTMF.
  • Any documents found within the email messages will be detached and included as imported, unclassified documents within the eTMF room.
  • Documents are NOT rendered to PDF.
  • Email message text is not captured.
  • Any file format is supported as an attachment, including .eml and .msg files.
  • If customers need any content rendered to PDF, such as .eml or .msg files, TPT Legal Services can do this for them as a service.

New in 9.2 is the ability to capture email correspondence and render all email content to PDF just by copying the eTMF. What we do in 9.2:

  • Existing 9.1 inbox functionality is untouched.
  • We have a new email Correspondence Inbox for eTMF and SSU. This Inbox will not only detach and include the email attachments, it will also render to PDF the email messages.
  • An interface exists where users can view all correspondence sent in to eTMF and SSU and decide whether or not to include it, either the email message or each attachment.
  • We have a new viewing engine that supports rendering to PDF 300+ formats, including .eml and .msg files.
  • If customers need any content rendered to PDF, such as .eml or .msg files, TPT Legal Services can do this for them as a service.
  • At times, due to the complexity of the format, .eml and .msg files will not render properly. If customers need any content rendered to PDF, such as .eml or .msg files, TPT Legal Services can do this for them as a service.

Again, if customers need to convert an archive of communications (.eml or .msf or .psd or .osd) to PDF we can do that as a service.