H1ST-AI-DOC-006 · Task 6.5
No one should work from last month's protocol
You should be able to trust that the version in front of you is the one to use, every time. The agent maintains a complete version lineage for every document, tracking changes, effective dates, and superseded status so only the current version is presented for use, and letting reviewers compare any two versions side by side to see exactly what changed and why. Superseded records are archived, not deleted, preserving the reconstructable history inspectors expect.
The grind you know
The moment a version slips out of control, someone on your team is working from an outdated protocol or form, and in a trial that is a GCP and safety risk you can't shrug off. Comparing revisions by hand is slow and easy to get wrong, so changes get missed. And without disciplined archiving, superseded records either linger as confusing duplicates or vanish entirely, breaking the audit trail you'll need later.
Part of the eTMF & Documents family
An eTMF that files and manages itself.
You should be able to trust that the version in front of you is the one to use, every time. The agent maintains a complete version lineage for every document, tracking changes, effective dates, and superseded status so only the current version is presented for use, and letting reviewers compare any two versions side by side to see exactly what changed and why. Superseded records are archived, not deleted, preserving the reconstructable history inspectors expect.
Each edit or new upload is captured as a discrete version with metadata and a change reason.
The agent renders side-by-side diffs so reviewers understand what changed between versions.
On supersession, prior versions move to a controlled archive under defined retention rules while the current version stays live.
Capabilities
Every save creates a tracked version with author, timestamp, and reason, forming a complete document history.
Reviewers diff any two versions to see additions, deletions, and edits at a glance.
The agent enforces current-version status so users always retrieve the approved, effective document.
Superseded versions are archived with retention rules rather than deleted, preserving the audit trail.
In practice
Where the agent shows up in the day-to-day of a live trial — the moments the grind usually lives in.
An amended protocol supersedes the prior version. The agent enforces effective and superseded status so retrieval always returns the current approved document, closing the GCP and safety risk of a site using an outdated form.
A reviewer needs to know what moved between two ICF versions. Side-by-side comparison highlights every addition, deletion, and edit with author and reason-for-change, instead of a manual line-by-line read.
An inspector asks to see a superseded version from a year ago. Because prior versions are archived under retention rules rather than deleted, the reconstructable lineage is there to retrieve.
Proof
Figures shown are pre-launch targets based on internal benchmarks, not guaranteed outcomes.
Veeva Vault
EDC
Who it's for
A BPMN-driven workflow engine that routes, approves, and lifecycles Trial Master File documents against the TMF Reference Model v3.3.1.
Learn moreA review and approval workflow with 21 CFR Part 11-compliant electronic signatures and a complete audit trail.
Learn moreAn intelligent dump-folder that auto-assigns metadata and files documents to the correct TMF location behind a review-and-approve gate.
Learn morePeace of mind
Every output is generated inside a validated, audit-ready platform, kept under human-in-the-loop control, and mapped to the regulatory and CDISC standards this agent supports.
Walk through it on your own workflow with a clinical-trials expert — no pressure, no obligation, and honest answers, including on the limits.
