Managing subject states (e.g., “Enrolled”, “Randomized”, “Discontinued”, etc.) is critical for study integrity—but mistakes can happen.
This update introduces clear guidance, visual cues, and compliance checks to make transitions safer and more transparent.
Here's What's New at a Glance:
Visual Dropdown Enhancements
All possible states are displayed, with previously reached states grouped under a Previous States section at the bottom—helping users avoid accidental reselection.
Guidance Throughout
Informational messages guide clinical staff at every step, including when reverting states, so decisions are informed and aligned with study protocols.
Warnings Before Every Change
A prominent message appears before any state update, reminding users to proceed only if the change is truly necessary.
Controlled State Reversions
When reverting to a previous state, users must provide a Reason for Change, and a Data Change Request (DCR) is automatically generated for audit purposes.
Valid Date Enforcement
Users must enter a valid date for any state change to ensure accurate and compliant data.
Let's Dive Deeper Into These Updates
A Smarter, Cleaner Dropdown
We’ve redesigned the Change Subject State dropdown to make it easier for site users to navigate. All possible states are displayed in a clear, structured list.
At the bottom, you’ll now see a dedicated Previous States section showing any states that have already been reached. These are ordered from most recent to oldest, so users can quickly understand the subject’s history and avoid accidental reselection.
Real-time indicators ensure the dropdown always reflects valid states and compliance rules.
Guidance Before You Act
Before making any subject state change, users now see a prominent warning message explaining the potential impact. This reminder encourages users to proceed only if the change is truly necessary.
And if you’re reverting a subject to a previous state, the system provides additional guidance—so decisions are informed and aligned with study protocols.
Going Back to a Previous State
Reverting a subject’s state is a sensitive action, so we’ve added safeguards:
Reason for Change Required: Users must provide a reason before confirming the update. There will be some standard pre-configured selections. If Other is selected, a mandatory free-text field appears (minimum 5 characters, maximum 1000 characters).
Automatic Audit Trail: Every reversion creates a Data Change Request (DCR) for compliance and traceability.
Flexible Approval Workflow: Depending on study settings, DCRs can be approved via self-service or require manual review by Data Management.
What This All Means for You
These safeguards reduce risk, improve compliance, and keep subject data accurate—while giving site users clear guidance and visibility so they can act confidently without worrying about unintended changes.
Additional Information
Category: New feature
Product: eCOA Swift
Version: 8.0
Release Date: December 21, 2025
Impact: eCOA
