General Product Information FAQs

Why can users copy text from PDF documents in Trial Interactive, even when DRM is enabled?

Copying text from PDF documents in Trial Interactive (TI) is working as designed in the current system. At present, neither the TI Viewer nor the Original Viewer restricts text selection or copy-paste actions once a user has view access to a PDF, regardless of user role (including Reader and Editor).

The current DRM functionality in TI only prevents document download; it does not encrypt the PDF or apply PDF-level permission restrictions such as disabling copy or print. As a result, DRM does not prevent users from selecting or copying text from a viewed PDF.

Additionally, the document rendering technology used by TI (including ARender) focuses on secure viewing, access control, encryption in transit, watermarking, and redaction, rather than enforcing intrinsic PDF rights restrictions like disabling copy-paste. Preventing text copying would require PDF encryption or a dedicated PDF DRM solution, which is not part of the current software.

At this time:

Copying text from PDFs is allowed for all user roles.
There are no configuration options to restrict copy-paste by role.
Restricting copy functionality would require PDF encryption and is considered a future product enhancement, not an existing capability.

Users who require stricter content protection should consider applying PDF security or DRM controls before uploading documents to TI. Any enhancement to support encrypted PDFs within TI would need to be evaluated and prioritized as a future improvement.

What settings are required to restrict users from downloading or printing PDF documents in the Trial Interactive (TI) Viewer?

To restrict PDF download and print actions in the TI Viewer for Reader and Editor roles, multiple room-level and document-level settings must be configured together. Enabling DRM alone is not sufficient.

To achieve the expected restrictions, a SuperAdmin must configure the following:

To restrict PDF download:

Navigate to Room Settings → Security and ensure Enable DRM is enabled.
Navigate to Room Settings → Documents → Export Configuration and uncheck the ‘Enable export (for all roles)’ option.
In the eTMF Module → Documents tab, configure folder security for the user as View Only.

To restrict PDF printing:

Navigate to Room Settings → Documents → Documents Module and uncheck the ‘Disable print for readers and editors’ option.
Ensure the document is accessed under View Only permissions.

Expected behavior after configuration:

The Download option is not available in the TI Document Viewer.
Downloads are restricted from the Documents Cart.
When the Print option is used, the PDF does not render the document content.

All relevant settings must be applied together for the restrictions to take effect consistently across the TI Viewer.

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.

What is the character limit for Comments fields in Metadata?

eTMF supports up to 4,000 characters in metadata text fields.

What is the criteria of uploading the video to the Collaborate rooms?

If users upload large or high-resolution video files, playback may be impacted. Recommended options include:

The video files should be uploaded in a lower resolution or otherwise reduced in size.
The video file should be downloaded to the user’s local machine for playing.

How are the calculations for the figures on the dashboard made?

Refer to the table below


Dashboard Name	Calculation Parameters	Availability (Rooms)	Clickable or Unclickable	View Modes
Countries	Number of countries in the room	eTMF Collaborate	Unclickable	Overview and Detailed View
Pending Sites	Number of inactive investigative sites	eTMF Study Start-Up	Unclickable	Overview and Detailed View
Active Sites	Number of active investigative sites	eTMF Study Start-Up	Unclickable	Overview and Detailed View
Total Documents	Overall number of documents in the room.	All rooms	Unclickable	Overview and Detailed View
Collected Documents	The number of collected documents. This number includes only ‘documents’ in all modules in a room, no deleted, purged, or missing documents.	eTMF Study Start-Up	Clickable	Detailed View
Missing Documents	The number of missing documents. This number includes all eTMF placeholders that have no document we can consider as collected. This is the difference between the number of requirements we have in a room and the number of requirements we have already collected. In the corresponding grid, we see all placeholders. We still have to submit a document and all submitted documents we do not consider as collected. For one placeholder, we may have several submitted documents and that makes a difference in the number of missing documents we have in the KPI dashboard and the grid.	eTMF Study Start-Up	Clickable	Detailed View
Required Coding	The number of non-final documents which are in a workflow.	eTMF Study Start-Up Note: It is available for eTMF or Study Start-Up rooms with the Workflow module enabled for Editors or higher-level users.	Clickable	Detailed View
Final Documents	The number of documents with final status.	eTMF Study Start-Up Note: Workflow module must be enabled.	Clickable	Detailed View
Expired Documents	The number of expired documents.	eTMF Study Start-Up Collaborate TI Docs	Clickable	Detailed View
Expiring Documents	The number of expiring documents. During the expiring period, we have configurable room-level settings. By ‘Expiration Dashboard View’ option, we set the number of days we consider the document as ‘Expiring’ before the expiration date.	eTMF Study Start-Up Collaborate TI Docs	Clickable	Detailed View
Open Queries	The number of Pending and InProgress queries.	All rooms with Query Resolution module enabled.	Clickable	Detailed View
eSignature requests	The number of documents that were sent to the eSignature workflow stage and were not signed yet.	Collaborate TI Docs	Clickable	Detailed View
eSignature in progress	The number of documents that were sent to the eSignature workflow stage and signing is in progress.	Collaborate TI Docs Note: The eSignature module must be enabled.	Clickable	Detailed View
Periodic Review	The number of documents that require periodic review.	Collaborate TI Docs Note: The eSignature module must be enabled for Editors and Higher-level users.	Clickable	Detailed View