Managing data edits shouldn’t be a manual burden. This update introduces automated safeguards that keep your study data accurate, auditable, and compliant—without slowing you down.
Here's What's New at a Glance:
Accelerated DCR Creation
Whenever you edit, deactivate, or add data, the system now generates a Data Change Request (DCR) automatically—no extra steps required.
Pre-Populated Details
Each DCR includes context-specific information such as previous and new values, reason for change, user credentials, and timestamps.
Audit-Ready Workflow
Once you sign off using your Clario Global Account credentials, the DCR closes automatically, and all actions are logged for full traceability.
Structured Change History
Every update is captured in the DCR history with clear descriptions, ensuring compliance with study protocols and regulatory standards.
Let's Dive Deeper Into These Updates
More Control, Less Waiting
Previously, any data change required a formal Data Change Request (DCR) handled by Clario’s Data Management team—adding time and complexity. Now, site users can make certain changes themselves, directly in context, without leaving the dashboard.
Three Permission Modes
Direct Edit (Self-Service): Site users can edit and save data immediately—ideal for studies that prioritize speed and trust site-level control.
Submit for Review: Changes are held in a pending state until approved by a designated reviewer. Reviewers can approve, reject, or query for clarification.
By Request Only: Site users submit a formal request; changes are applied manually after review.
How It Works
Navigate to the participant or form where the change is needed.
Make your edit, provide a reason, and sign off using your Clario Global Account credentials.
The system auto-generates a DCR, logs all details, and applies the configured workflow (immediate, pending, or request-only).
Users can submission status and cancel requests if needed—cancellations require a reason and are logged for compliance.
Compliance Built In
Every change is pre-populated with context (study, site, participant, form).
Electronic sign-off ensures 21 CFR Part 11 compliance.
Full audit trail with timestamps, user IDs, and version history.
Why It Matters
The flexibility of self-service DCRs empowers clinicians—something we heard repeatedly during on-site visits and user research. This means:
Faster Resolutions: No waiting for Data Management approval for routine changes.
Greater Flexibility: Handle updates when they’re needed, without breaking workflow.
Full Compliance: Every change is tracked and auditable, meeting regulatory standards.
Additional Information
Category: New feature
Product: eCOA Swift
Version: 8.0
Release Date: December 21, 2025
Impact: eCOA
