--- title: "SDV, Source Data Verification | MedTech Terms" description: "Process of comparing data in case report forms against original source records. 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This approach, endorsed by ICH E6(R3), optimizes resource allocation." } }, { "@type": "Question", "name": "What are common sources for SDV?", "acceptedAnswer": { "@type": "Answer", "text": "Common source documents include electronic health records (EHRs), laboratory reports, pharmacy records, and paper charts. Any document where original clinical observations are recorded can serve as a source." } }, { "@type": "Question", "name": "Can SDV be automated?", "acceptedAnswer": { "@type": "Answer", "text": "While fully automated SDV is rare due to the need for human judgment in interpretation, technology can facilitate the process. Electronic data capture systems with built-in edit checks can identify discrepancies, and some tools can compare select data points from different sources." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Source Data Verification [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)SDV # Source Data Verification Process of comparing data in case report forms against original source records. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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). 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](/terms/risk-based-monitoring), allowing for a more targeted SDV approach. ## What this means in practice [Risk-based monitoring](/terms/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 How does risk-based monitoring affect SDV? [Risk-based monitoring](/terms/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. What are common sources for SDV? Can SDV be automated? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ ALCOA+ ](/terms/alcoa-plus) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials ALCOA+ Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available). ](/terms/alcoa-plus)[ Clinical & Trials ICH E6 Good Clinical Practice(GCP) International standard for the design, conduct, and reporting of clinical trials. ](/terms/ich-gcp) ### More in Clinical & Trials · Same category [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event)[ Clinical & Trials Analytical Sensitivity An IVD's ability to detect small quantities of an analyte. ](/terms/analytical-sensitivity)[ Clinical & Trials Bayesian Trial Design Trial design that uses Bayesian statistics, often incorporating prior data from related studies or registries. ](/terms/bayesian-trial) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ICH· 2 ISO· 1 1. [1 ICH E6(R3) Verified ICH · database.ich.org ](https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym SDV Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=sdv) Learn in 60 seconds Card Lesson Quiz Process of comparing data in case report forms against original source records. - · Risk-based monitoring approaches under ICH E6(R3) reduce the volume of SDV in favor of targeted verification of critical data and processes. Remember this Watch out: Over-reliance on 100% SDV can be inefficient and may not improve data quality as much as risk-based approaches. Related terms - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [ALCOA+ ](/terms/alcoa-plus) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Case Report Form(CRF) ](/terms/case-report-form) - [Electronic Data Capture(EDC) ](/terms/edc) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Clinical Evaluation Report(CER) ](/terms/cer) - [IDE Annual Progress Report ](/terms/ide-annual-report) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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