What is Source Data Verification?

Source Data Verification (SDV) is the process of comparing data entered into the clinical trial system (like an EDC) with the source records, such as medical charts, lab reports, or device outputs, to confirm that the data is accurate, complete, and consistent with what was originally recorded.

Source Data Verification is carried out as part of trial monitoring activities to confirm the reliability and accuracy of participant data collected during a study. Clinical monitors conduct SDV at investigational sites, either through on-site visits or remote review, by comparing data entered in the EDC with source documents. The focus is typically on critical data points such as informed consent documentation, subject eligibility, primary and secondary endpoints, safety events, and essential laboratory results. By identifying and resolving discrepancies early, SDV helps maintain data integrity, supports credible study outcomes, and strengthens sponsor confidence in the overall quality of trial data.

Clinion facilitates Source Data Verification  (SDV) through integrated features that allow monitors to validate study data effectively. Its EDC and eSource functionalities provide secure access to both source documents and captured data for on-site and remote monitoring. Monitors can review key data points, create and resolve queries, and log SDV status directly within the platform. Role-based permissions, audit trails, and real-time system updates support transparency and oversight. By supporting focused and risk-based SDV workflows, Clinion streamlines monitoring activities while preserving high standards of data quality.

All source data is automatically linked to the participant’s profile and integrated with Clinion EDC, enabling seamless source-to-EDC data flow, source data verification (SDV), and complete audit trails. With secure, centralized access for monitors and study teams, Clinion ensures data integrity, real-time visibility, and compliance with regulatory requirements throughout the trial lifecycle.

In practice, Source Data Verification with Clinion involves monitors accessing the system to review selected subject records during on-site or remote monitoring. They compare EDC entries with available eSource documents, focusing on critical data such as consent dates, eligibility, safety events, and key assessments. Any discrepancies are raised as queries within the system and resolved by site staff. Verification status is updated in real time, with all actions captured in audit trails, creating a clear and well-documented monitoring workflow.

Source Data

Monitoring

CRA

Data Verification

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