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.

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Smart Data Quality (SDQ) Protocol Deviations

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

Zero duplicates

Existing PDs surfaced before you create a new one

Query-based and non-query-based PDs managed together and synced to CTMS

How Protocol Deviation management works

PD management runs as a four-step workflow, from definition to dashboard review.

Define

Define PD-related checks and listings as part of the data review plan — as DQ checks or interactive review listings.

Implement

Program the checks and listings via the Co-Pilot, based on inputs from medical monitors and data managers.

Identify and Flag

In the non-query workflow, clinical reviewers mark records as PD during review; in the query workflow, a Data Discrepant = Yes flag on a closed query drives the PD.

Review on Dashboard

Clinical reviewers approve or reject PDs from an interactive dashboard that visualizes deviations by category and aging.

Built to prevent duplicates. Before a new PD is created, SDQ surfaces previously raised PDs for the same study context, so the same deviation isn’t logged twice across the query and non-query workflows.

Features

PD definition and customization

Define PD checks and listings and add custom fields like PD Classification, Category, and free-text description.

Dual workflow support

Query-based and non-query-based PDs handled in one module.

Duplicate prevention

Existing PDs detected and surfaced by study context.

Configurable PD controls

Enable or disable PDs at account or study level and add study-specific fields shown during review and CTMS sync.

Interactive PD dashboard

Visualize PDs by status, navigate by category, and view summary metrics and aging.