eTMF Connect Spring 2026 Release

If you manage a growing clinical trial portfolio, you know the feeling: too much time spent on administrative cleanup, too little visibility into what is actually complete, and constant pressure to stay inspection-ready with a lean team. Our latest product update Core 1.19.0 addresses several of those realities directly.

Here's what's new 👇

Query Task: Stop chasing down rejected documents

A rejected document used to mean a small crisis. You had to figure out why it was rejected, then jump between screens to fix the metadata, upload a corrected version, or reclassify the file. For teams managing multiple studies across multiple sites, that adds up fast.

The new Query Task feature brings all of that into one place. Document owners see the rejection reason, who raised it, and when, right on the task details page. From there, they pick their resolution: update the metadata, upload a new version, resend without changes, delete the document, or reclassify it. The system logs every action automatically, so your audit trail is complete without anyone having to think about it.

This is a heavily requested feature from our customers. If rejected documents have been slowing your team down, this one is for you!

Artifact Linking: Connect the documents that belong together

Clinical trial documentation does not always follow a neat filing structure. Translations, notes to file, and supporting records often end up scattered across different sections of your TMF, and finding the right related document at the right moment costs time you do not have.

Artifact Linking lets any user with contribute permissions associate related documents directly to one another, regardless of their current status. Incomplete, final, or under revision, artifacts can be linked and accessed from a new Links tab. You can view, navigate to, or remove associations at any time.

The result is better document organization and faster discoverability across your TMF, without changing how your files are stored or classified. Links are lightweight and do not affect core metadata or document lifecycle.

This was another one of the most requested features from clients. It is now available to all users in this release.

Feature Management: Set up eTMF Connect to match how your team works

No two clinical operations teams work exactly the same way.

The Feature Management page gives eTMF Connect Application Managers significantly more control. You can enable or disable metadata fields like Certified Copy, manage QC task routing and duration settings, and define which user groups are authorized to initiate revision requests. You also choose between a streamlined or collaborative revision workflow, depending on how your team operates.

The benefit is more flexibility to set preferences based on your company's procedure rather than one your team has to adapt to.

Signpost Management: Account for every document, even the ones stored elsewhere

Regulatory inspectors do not care that a document lives in an external portal or a separate system. If it is not visible in your TMF inventory, it looks like a gap, and gaps invite scrutiny.

Signpost Management closes that visibility problem without requiring you to duplicate files. Users create official pointers, called signposts, from the staging area or as placeholders. Each signpost requires a reference field, such as a URL or location description, so anyone reviewing the TMF knows exactly where the actual document resides.

Signposts appear in your artifact table alongside regular documents, support filtering and search, and are tracked for audit purposes. They follow the same lifecycle as other artifacts. If the actual document becomes available in eTMF Connect later, you delete the signpost and file the document directly. 

For teams preparing for their first regulatory inspection or managing studies across external systems, this feature directly reduces one of the harder-to-explain completeness gaps.

Expected Artifact List: Know where you stand before the inspector does

Inspection anxiety is real, especially when you cannot see at a glance where your TMF stands against the documents you planned to collect. 

The Expected Artifact List gives you that answer. This new inventory view shows planned versus actual artifacts in real time, broken down by document type and TMF level. You see if you have filed what you have planned at a glance and drill into specific sites or document types to find gaps, misclassifications, or missing placeholders before they become findings. 

From the same view, you can add or remove placeholders directly, filter and sort to zero in on problem areas, and adjust your plan without leaving the screen. 

This is not just a reporting feature. It is a planning tool for teams that want to stay ahead of inspections rather than scramble before them. It is available to all clients in this release. 

Get started with the eTMF Connect Spring 2026 Release

Already an eTMF Connect client? All five features in Core 1.19.0 reach client environments April 2, 2026.