--- title: "EDC, Electronic Data Capture | MedTech Terms" description: "Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/edc#term", "name": "Electronic Data Capture", "alternateName": "EDC", "description": "Electronic Data Capture (EDC) systems are validated software platforms used to design electronic Case Report Forms (eCRFs), collect clinical data from investigator sites, run edit checks, manage queries, and produce locked datasets for analysis. Common platforms include Medidata Rave, Veeva Vault EDC, Oracle InForm, and Castor. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Electronic Data Capture [All terms](/terms) Clinical & Trials [Software Lifecycle](/ecosystems/software-lifecycle)[Clinical Evidence](/ecosystems/clinical-evidence)EDC # Electronic Data Capture Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition [Electronic Data Capture](/terms/case-report-form) (EDC) systems are validated software platforms used to design electronic Case Report Forms (eCRFs), collect clinical data from investigator sites, run edit checks, manage queries, and produce locked datasets for analysis. Common platforms include Medidata Rave, Veeva Vault EDC, Oracle InForm, and Castor. EDC systems generate audit trails, enforce role-based access, and integrate with related systems, Clinical Trial Management Systems (CTMS), eConsent, ePRO, randomization (IRT/IWRS), safety databases, and electronic Trial Master Files ( [eTMF](/terms/trial-master-file)). What the regulation says 21 CFR Part 11 governs electronic records and signatures used in FDA-regulated activities. ICH E6(R3) and [ISO 14155](/terms/iso-14155) require validated systems for trial data collection with audit trails, access controls, and data integrity safeguards (ALCOA+). FDA's 'Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations' guidance (2023, draft) updates the agency's expectations. ## What this means in practice [EDC](/terms/case-report-form) is foundational to modern clinical trial conduct. Sponsors must validate EDC systems per 21 CFR Part 11 (electronic records and signatures), maintain audit trails, and demonstrate data integrity meets ALCOA+ principles. For [IDE](/terms/ide) device trials, EDC validation, user [training records](/terms/training-records), and [source data verification](/terms/sdv) approach are routinely inspected by FDA bioresearch monitoring inspectors. The shift toward [Risk-Based Monitoring](/terms/risk-based-monitoring) (RBM) and Decentralized Clinical Trials ( [DCT](/terms/decentralized-clinical-trial)) is built on EDC capabilities including remote source data review and real-time anomaly detection. Common pitfalls - • Treating EDC validation as a vendor responsibility, sponsors are accountable for the validation evidence in their environment, with their configuration. - • Skipping or shortcutting 21 CFR Part 11 audit-trail review during inspection readiness. - • Underestimating data migration risk when switching EDC platforms mid-study, FDA expects defensible mapping and re-validation. ## 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 Case Report Form(CRF) Structured paper or electronic forms used to capture protocol-required data for each enrolled subject. ](/terms/case-report-form)[ Clinical & Trials Decentralized Clinical Trial(DCT) A trial that uses telehealth, home-based assessments, wearables, and direct-to-patient logistics to reduce or eliminate site visits. ](/terms/decentralized-clinical-trial)[ Clinical & Trials Risk-Based Monitoring(RBM) Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification. ](/terms/risk-based-monitoring) ### More in Clinical & Trials · Same category [ Clinical & Trials Source Data Verification(SDV) Process of comparing data in case report forms against original source records. ](/terms/sdv)[ Clinical & Trials Trial Master File(TMF) The collection of essential documents that demonstrates the conduct of a clinical trial complies with GCP and applicable regulatory requirements. ](/terms/trial-master-file)[ 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) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Software Lifecycle](/ecosystems/software-lifecycle) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 NIH· 1 1. [1 21 CFR Part 11 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11) 2. [2 Electronic Systems in Clinical Investigations Guidance Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions-and) 3. [3 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) 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. 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On this term Category Clinical & Trials Acronym EDC Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=edc) Learn in 60 seconds Card Lesson Quiz Software systems used to collect, manage, and report clinical trial data electronically, replacing paper case report forms. - · EDC is foundational to modern clinical trial conduct. - · Sponsors must validate EDC systems per 21 CFR Part 11 (electronic records and signatures), maintain audit trails, and demonstrate data integrity meets ALCOA+ principles. - · For IDE device trials, EDC validation, user training records, and source data verification approach are routinely inspected by FDA bioresearch monitoring inspectors. Remember this Watch out: Treating EDC validation as a vendor responsibility, sponsors are accountable for the validation evidence in their environment, with their configuration. Related terms - [ALCOA+ ](/terms/alcoa-plus) - [Case Report Form(CRF) ](/terms/case-report-form) - [Trial Master File(TMF) ](/terms/trial-master-file) - [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring) - [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [ISO 14155 ](/terms/iso-14155) - [Source Data Verification(SDV) ](/terms/sdv) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Feasibility Study ](/terms/feasibility-study) - [First-in-Human Study(FIH) ](/terms/fih) - [Investigator Brochure(IB) ](/terms/investigator-brochure) - [Pivotal Trial ](/terms/pivotal-trial) - [Real-World Data(RWD) ](/terms/rwd) - [Contract Research Organization(CRO) ](/terms/cro) [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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