Source data verification is the process of comparing data recorded in the case report form with the original source documents to confirm it is accurate and complete.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Changed by Data manager · reason: critical safety value added
In short
Explained
For many years monitors verified every data point against source at every site visit. Analyses of monitoring practices found that this exhaustive approach changed very little data, and that most of the errors it caught had no effect on the study's conclusions. At the same time, it was one of the largest costs in running a trial.
Modern guidance, including FDA's guidance on risk-based monitoring and ICH E6, encourages sponsors to identify the data and processes critical to participant safety and result reliability and focus verification there. Remaining data is covered by centralised review, edit checks and targeted SDV based on risk. See risk-based monitoring.
When sites can give monitors secure remote access to source records, SDV can happen without travel. It depends on local rules about access to medical records and on the site's systems. Remote SDV and on-site visits are often combined.
In Capture
Tick the fields that need verification on each form. Only fields in the critical set show an SDV marker; monitors verify field by field or all at once and submit. The SDV set can change after approval, creating a new SDV configuration version with a reason, and calculated fields are excluded automatically.
Changed by Data manager · reason: critical safety value added
Source data verification.
SDV checks that CRF data matches source. SDR reviews source documents more broadly for protocol compliance, quality and issues that may not be in the CRF.
No. Regulators accept risk-based approaches that focus verification on critical data, supported by centralised monitoring.
Typically consent, eligibility, primary and key secondary endpoints, dosing and safety data, based on your risk assessment.
Per-field SDV configuration in a free sandbox.