Smart Data Quality (SDQ)
Protocol Deviations
Review query-based and non-query-based protocol deviations collaboratively inside SDQ — with duplicate detection and downstream CTMS integration.
Protocol deviation management, without the duplicates
Rule-based Protocol Deviation (PD) management lets clinical reviewers and other roles review protocol deviations efficiently through collaborative workflows and modern UI components. The workflow covers both non-query-based and query-based deviations in one place.
Previously raised PDs are surfaced during review to prevent duplicates, and every change is logged to the audit trail — keeping PD management collaborative, de-duplicated, and inspection-ready.
Why teams choose Protocol Deviation management
Dual workflow support
Identify query-based PDs from site responses, and create non-query-based PDs directly from the To-Do list, IRL, Discrepancy Management, and Missing Pages.
Duplicate prevention
Existing PDs are surfaced based on study context — subject, visit, and more — to stop duplicate entries.
Role-based review
Clinical reviewers, medical monitors, and data managers get tailored access with an inline review-and-approval interface.
CTMS integration and audit readiness
PD details are available via API for downstream systems like CTMS, with structured export for traceability.
Zero duplicates
How Protocol Deviation management works
PD management runs as a four-step workflow, from definition to dashboard review.
Features
Define PD checks and listings and add custom fields like PD Classification, Category, and free-text description.
Query-based and non-query-based PDs handled in one module.
Existing PDs detected and surfaced by study context.
Enable or disable PDs at account or study level and add study-specific fields shown during review and CTMS sync.
Visualize PDs by status, navigate by category, and view summary metrics and aging.
API access for downstream systems and structured export for audit readiness.
