Document Functions

Why were users not automatically transitioned to the new enhanced TI Viewer for all supported document types (e.g., Word, Excel)?

Users were not automatically transitioned because the enhanced TI Viewer must be explicitly enabled in the room configuration for it to apply to supported document types.

Why did the client have to manually enable the enhanced TI Viewer for Excel files if it was stated to be “enabled by default”?

This is a common misunderstanding. The viewer itself must still be enabled in the room configuration. What was “enabled by default” was an improvement to the viewer’s functionality, not the activation of the viewer for all file types.

Is this expected behavior, and if so, can documentation be provided to clarify this for clients?

Yes, this is expected system behavior. Documentation should clarify that the enhanced TI Viewer must be enabled in the room configuration to take effect, even though some improvements to the viewer are enabled by default.

What are the functional differences between the Original TI Viewer, the Previous Viewer, and the Enhanced TI Viewer?

There are three viewers with distinct functions:

  • Original Viewer: Opens the file directly in the browser.
  • TI Viewer (Previous Viewer): Uses ARender to convert most file types to PDF for display.
  • Enhanced TI Viewer (TI Editor): Uses OnlyOffice to view (and edit) Microsoft Office files and can also function as a viewer for these file types.

What are the intended use cases for each viewer?

Viewer selection depends on the use case:

  • TI Viewer (ARender): Best for general use cases where files are converted to PDF for consistent rendering.
  • Enhanced TI Viewer (TI Editor / OnlyOffice): Best suited for viewing and editing Microsoft Office files (Word, Excel, PowerPoint).
  • Original Viewer (Native Browser Viewer): Ideal for files already in PDF format or for media files such as videos.

Why does TI continue to offer multiple viewer options instead of a single unified viewer?

Each viewer excels at different tasks—no single viewer provides optimal performance across all file types and use cases. Maintaining multiple viewers allows users to choose the best tool for their specific document types and workflows.

Can the Markup and Balloons display mode be set as the default within OnlyOffice to ensure consistent rendering of tracked changes?

While it is technically possible to set Markup and Balloons as the default display mode in OnlyOffice, there is currently no configuration available to apply this setting globally across all documents. At this time, it is only configured for specific use cases, such as CTMS visit reports.

If this setting is not configurable due to OnlyOffice limitations, is there a workaround or potential for future enhancement?

There is no direct configuration workaround available within the current system. To request this as an enhancement, it is recommended to create an AHA ticket so the feature can be considered for future development.

Should clients consider re-uploading these older documents in zipped format as a workaround, or is a more scalable solution available?

Re-uploading the documents in zipped format could be a viable workaround; however, the issue should be investigated first to determine whether a broader, more sustainable solution is available.

Why are Site Visit Documents generated from a CTMS Collaborate Room (CCR) not auto-filing into the linked eTMF as Final, despite being finalized and signed in the CCR?

Site Visit Documents finalized and signed in the CCR are expected to auto-file into the linked eTMF with a status of Final, bypassing Indexing and Review workflows. The current behavior—where documents are instead available for Indexing and Review—indicates a defect and does not align with the intended functionality.

Why are tracked changes not visible when viewing Word documents in ARender or Adobe, and how can users ensure they render correctly in OnlyOffice within the room?

It is expected behavior for ARender and Adobe not to display Word comments or tracked changes, as these viewers do not support that functionality. To view tracked changes, Microsoft Word or OnlyOffice must be used. Although Word documents were configured to render with OnlyOffice for supported file types (.doc, .docm, .docx, .dotm, .dotx), users noticed that tracked changes were only visible when comments were present. Further testing showed OnlyOffice uses display modes such as Final, Original, and Markup, and may default to a mode that hides changes. Switching to “Markup and Balloons” displays tracked changes correctly.

How do font types function in the OnlyOffice and ARender rendering systems?

Document rendering servers (OnlyOffice and ARender) rely on pre-installed fonts within the operating system to maintain consistent document appearance across platforms. When a document requests a font that is not available on the servers, the system substitutes a similar font. If no close match is found, formatting differences may occur.

What is the difference between licensed and free fonts?

  • Licensed fonts: Require a purchased license and are not installed by default due to legal and cost restrictions. If a document uses a licensed font that is not available, the system substitutes a similar font, which may alter appearance. Clients may need to arrange licensing if these fonts are required.
  • Free fonts: Are openly available and can be installed without legal or cost barriers. Documents using free fonts render correctly as long as the required font is installed on the server.

What steps should users take when encountering document rendering issues related to font types?

When there is a rendering issue related to font substitution, follow these steps:

  • Confirm the issue: Verify whether the issue is due to font substitution by reviewing the document on the rendering servers.
  • Check font availability: Determine whether the required font is installed. If it is a licensed font not included by default, inform the client about licensing restrictions.
  • Escalate if necessary: If a supported font is not rendering correctly, escalate to the support team for investigation.
  • Client communication: Explain that font availability depends on licensing. If a specific licensed font is required, the client may need to coordinate licensing arrangements.

What steps should the Implementation Team take when onboarding QMS clients regarding font types?

The Implementation Team should:

  • Gather information about the font types used by the client.
  • Update templates and documentation to ensure font type details are recorded.
  • Verify whether required fonts are supported by the rendering servers.
  • If an unsupported font is identified, contact the Service Desk to proactively resolve the issue.

What responsibilities do Product Managers have regarding font support on rendition servers?

Product Managers must:

  • Update the user guide to list the font types supported by the rendition servers.
  • Regularly review and curate the list of supported fonts to ensure popular fonts are available on the rendition servers.

What is the list of Audit Activity Types and Actions in Trial Interactive?

The list of Audit Activity Types and Actions includes:

    • Document Actions
    • Add Document URL
    • Change Control Workflow - Collaborative Review
    • Completed Change Control Workflow - Collaborative Review
    • Created Check in Document after Editing
    • Check Out Document for Editing
    • Copy Document from Room
    • Delete Attachment
    • Delete Document
    • Document Copied to Room
    • Document Edit Mode Switched
    • Edit Document Online
    • Edit Document Online Accessed
    • Move Document to Folder
    • Metadata Update
    • Export Document
    • Lock Document Profile
    • Mass Coding
    • New Attachment
    • New Document Profile
    • Open Document
    • Open Document Metadata
    • QC Workflow - Claim Document
    • QC Workflow - Exclude
    • QC Workflow - Release Document
    • QC Workflow - Swim Lane
    • Reject Document
    • Replace Attachment
    • Restore Document
    • Save Document
    • Security Update
    • Set Document Start Version
    • Unlock Document Profile
    • Update Default Field Value
    • Update Document URL

Where can Activity Types and Actions be found in the audit trail?

Activity Types and Actions can be found in the dropdown lists within the audit trail filters. These filters provide a list of various document-related actions, such as “Add Document URL,” “Delete Document,” “Mass Coding,” and others.

Why were users not automatically transitioned to the new enhanced TI Viewer for all supported document types (e.g., Word, Excel)?

Users were not automatically transitioned because the enhanced TI Viewer must be explicitly enabled in the room configuration for it to apply to supported document types.

Why did the client have to manually enable the enhanced TI Viewer for Excel files if it was stated to be “enabled by default”?

This is a common misunderstanding. The viewer itself must still be enabled in the room configuration. What was “enabled by default” was an improvement to the viewer’s functionality, not the activation of the viewer for all file types.

Is this expected behavior, and if so, can documentation be provided to clarify this for clients?

Yes, this is expected system behavior. Documentation should clarify that the enhanced TI Viewer must be enabled in the room configuration to take effect, even though some improvements to the viewer are enabled by default.

What are the functional differences between the Original TI Viewer, the Previous Viewer, and the Enhanced TI Viewer?

There are three viewers with distinct functions:

  • Original Viewer: Opens the file directly in the browser.
  • TI Viewer (Previous Viewer): Uses ARender to convert most file types to PDF for display.
  • Enhanced TI Viewer (TI Editor): Uses OnlyOffice to view (and edit) Microsoft Office files and can also function as a viewer for these file types.

What are the intended use cases for each viewer?

Viewer selection depends on the use case:

  • TI Viewer (ARender): Best for general use cases where files are converted to PDF for consistent rendering.
  • Enhanced TI Viewer (TI Editor / OnlyOffice): Best suited for viewing and editing Microsoft Office files (Word, Excel, PowerPoint).
  • Original Viewer (Native Browser Viewer): Ideal for files already in PDF format or for media files such as videos.

Why does TI continue to offer multiple viewer options instead of a single unified viewer?

Each viewer excels at different tasks—no single viewer provides optimal performance across all file types and use cases. Maintaining multiple viewers allows users to choose the best tool for their specific document types and workflows.

Can the Markup and Balloons display mode be set as the default within OnlyOffice to ensure consistent rendering of tracked changes?

While it is technically possible to set Markup and Balloons as the default display mode in OnlyOffice, there is currently no configuration available to apply this setting globally across all documents. At this time, it is only configured for specific use cases, such as CTMS visit reports.

If this setting is not configurable due to OnlyOffice limitations, is there a workaround or potential for future enhancement?

There is no direct configuration workaround available within the current system. To request this as an enhancement, it is recommended to create an AHA ticket so the feature can be considered for future development.

Should clients consider re-uploading these older documents in zipped format as a workaround, or is a more scalable solution available?

Re-uploading the documents in zipped format could be a viable workaround; however, the issue should be investigated first to determine whether a broader, more sustainable solution is available.

Why are Site Visit Documents generated from a CTMS Collaborate Room (CCR) not auto-filing into the linked eTMF as Final, despite being finalized and signed in the CCR?

Site Visit Documents finalized and signed in the CCR are expected to auto-file into the linked eTMF with a status of Final, bypassing Indexing and Review workflows. The current behavior—where documents are instead available for Indexing and Review—indicates a defect and does not align with the intended functionality.

Why are tracked changes not visible when viewing Word documents in ARender or Adobe, and how can users ensure they render correctly in OnlyOffice within the room?

It is expected behavior for ARender and Adobe not to display Word comments or tracked changes, as these viewers do not support that functionality. To view tracked changes, Microsoft Word or OnlyOffice must be used. Although Word documents were configured to render with OnlyOffice for supported file types (.doc, .docm, .docx, .dotm, .dotx), users observed that tracked changes were only visible when comments were present. Further testing showed OnlyOffice uses display modes such as Final, Original, and Markup, and may default to a mode that hides changes. Switching to “Markup and Balloons” displays tracked changes correctly.

Are there any restrictions on what documents can be merged in Trial Interactive?

Trial Interactive can merge files up to 3 MB per file. The following document types are supported by the Merge function:

  • doc
  • docx
  • ppt
  • pptx
  • pdf

What characters are illegal in exported filenames in Trial Interactive (for archives or exports)?

The following characters are illegal in exported filenames. Some are illegal on Windows, while others are illegal on macOS or Linux/Unix:

  • # (pound) [valid on Windows only]
  • % (percent)
  • & (ampersand) [valid on Windows only]
  • { (left curly bracket)
  • } (right curly bracket)
  • $ (dollar sign)
  • ! (exclamation point)
  • ' (single quote)
  • + (plus sign)
  • ` (backtick)
  • = (equal sign)
  • < (less than)
  • > (greater than)
  • : (colon)
  • " (double quote)
  • / (forward slash)
  • \ (backslash)
  • | (vertical bar / pipe)
  • ? (question mark)
  • * (asterisk)

How does Trial Interactive define key terms about documents and placeholders?

The following are key terms related to documents and placeholders:

  • Unfulfilled placeholders / missing: The count of placeholders required by the eTMF that are still waiting to be collected or marked final. Also referred to as missing required documents or “missing.”
  • Fulfilled placeholders: The count of placeholders that have been collected, indexed, QC’d, and marked as final in the eTMF.
  • Collected: The total count of final, collected documents in the eTMF. This includes fulfilled placeholders as well as additional documents and versions where more than one document fulfills a requirement. For non-TMF rooms, this metric may represent non-final documents depending on room configuration.
  • Overdue: The count of unfulfilled placeholders past the due date driven by a completed event or milestone. Due dates are calculated based on the event completion date plus a configured due date period.

Why do identical documents sometimes have different hash values?

Some operating systems and word processing applications (for example, Microsoft Word when using “Save As”) may add non-visible data to a file. While the document appears identical when opened, these differences can result in a different hash value, allowing seemingly identical documents to be stored in the same TI room.

Why are PDF form fields editable in the Original Viewer?

Some PDFs include form fields designed to be editable. These fields can still appear editable in the Original Viewer because it is the browser’s native PDF viewer and displays the document as-is. Changes made in this viewer are not saved within TI. To view the rendered output used by TI, open the document in the TI Viewer, which is the recommended option.

What is the function of the OCR indicator in the bottom-left corner (first IT slide), and how is error handling managed? Can clients correct OCR accuracy, or is it provided “as it is”?

Once OCR and ML Automation are enabled, OCR processing runs automatically and can be configured. ML can also be used to optimize OCR behavior based on document type.

What is the data flow when emailing a document into the eTMF system?

The typical flow is as follows:

  • Client sends the email.
  • TI email service receives the message and sends an acknowledgment.
  • TI service performs virus scans, security checks, and macro analysis.
  • The email is routed to the appropriate study room inbox.
  • If metadata is available, the system attempts to classify the attachments.
  • If routed to an email correspondence inbox, the email is made available for relevance review and converted to PDF.
  • Attachments are processed by the TI OCR service.
  • Optional Automate service classifies documents and extracts metadata.
  • Final documents are routed to the appropriate eTMF index locations.

Note: Additional workflows exist for query-based email flows.