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Source Data Verification
Process of comparing data in case report forms against original source records.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
SDV is a quality activity where monitors verify that data captured in eCRFs accurately reflect source documents (typically the EHR, lab reports, or paper records). Traditional 100% SDV is costly, so ICH E6 and FDA's risk-based monitoring guidance support targeted SDV focused on critical data, such as primary endpoints, eligibility and serious adverse events, combined with central statistical monitoring. Monitoring plans state the SDV approach, and findings become queries the site must resolve before database lock. What the regulation says
Source Data Verification (SDV) is a crucial process in clinical trials, ensuring the reliability and integrity of trial data. Regulatory bodies like the FDA (21 CFR Part 312) and ICH E6(R2) emphasize the importance of data accuracy and verification, though they also support risk-based approaches to monitoring. The ICH E6(R3) guideline further encourages sponsors to implement a system of quality management that includes risk-based monitoring, allowing for a more targeted SDV approach.What this means in practice
Risk-based monitoring approaches under ICH E6(R3) reduce the volume of SDV in favor of targeted verification of critical data and processes.Examples
- A clinical research associate compares the reported adverse event dates in the electronic Case Report Form (eCRF) with the corresponding entries in the patient's hospital medical record to verify accuracy.
- During a site audit, the monitor confirms that the dosage of an investigational drug recorded in the eCRF matches the dosage documented in the pharmacy dispensing logs.
- A data manager reviews a random sample of patient demographic data in the eCRF against the source documents to ensure consistency and identify any entry errors.
Common pitfalls
- •Over-reliance on 100% SDV can be inefficient and may not improve data quality as much as risk-based approaches.
- •Inadequate documentation of source data can complicate or invalidate SDV efforts.
- •Failure to define critical data elements can lead to misdirected SDV activities.
- •SDV should not be the sole method for ensuring data quality, as it does not detect all types of errors or fraud.
Frequently asked questions
Risk-based monitoring focuses SDV efforts on critical data and processes most essential for patient safety and study integrity, rather than verifying all data points. This approach, endorsed by ICH E6(R3), optimizes resource allocation.
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3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
Link health: 3 verified· last checked 2026-06-20
ICH·2ISO·1
- 1ICH E6(R3)Tier 2 VerifiedICHdatabase.ich.org
- 2ICH GuidelinesTier 2 VerifiedICHich.org
- 3ISO 14155 Standard PageTier 1 VerifiedISOiso.org
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