What is Source Data?

Source data refers to the original, first-hand information collected about a participant during a clinical trial. This includes records in medical charts, lab reports, imaging results, patient diaries, or electronic devices that document observations, measurements, or other trial-related information. Source data serves as the foundation for all trial records and is used to verify accuracy, ensure data integrity, and support regulatory compliance.

Source data is used throughout clinical trials as the primary reference for all participant information and study results. It is collected during screening, enrollment, study visits, procedures, and follow-ups, including lab tests, vital signs, imaging, and patient-reported outcomes.This data is the primary reference for verifying case report forms (CRFs), supporting monitoring, audits, and regulatory submissions, and maintaining the overall integrity of trial results.

Clinion implements source data management through its eSource and ePRO solutions, capturing original participant data directly from sites, connected devices, and participants themselves. Clinical data such as vital signs, lab results, clinician-entered source data, and patient-reported outcomes are recorded electronically at the point of origin, reducing transcription and manual errors.

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, site staff enter and capture data directly at the point of care using Clinion eSource and ePRO, making these electronic entries the primary source of truth. The data is immediately linked to the participant’s study record and flows into Clinion EDC without re-entry.

Monitors access the same source records remotely to verify that submitted study data aligns with the original entries, with full audit trails capturing who entered, reviewed, or updated the data and when. This streamlined approach reduces transcription errors, supports efficient SDV, and maintains data accuracy and regulatory compliance throughout the study.

Source Documentation

Source Data Verification (SDV)

Original Data

eSource

Direct Data Entry

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eSource