--- title: "CRF, Case Report Form | MedTech Terms" description: "Structured paper or electronic forms used to capture protocol-required data for each enrolled subject. Plain-English Clinical & Trials definition for MedTech te" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/case-report-form#term", "name": "Case Report Form", "alternateName": [ "CRF", "eCRF", "Electronic Data Capture", "EDC" ], "description": "A Case Report Form (CRF) is the structured instrument, paper or, almost universally now, electronic (eCRF) within an Electronic Data Capture (EDC) system, used to record protocol-required data for each enrolled subject. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Case Report Form [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)CRF # Case Report Form Structured paper or electronic forms used to capture protocol-required data for each enrolled subject. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 9, 2026 ## Definition A Case Report Form (CRF) is the structured instrument, paper or, almost universally now, electronic (eCRF) within an [Electronic Data Capture](/terms/edc) (EDC) system, used to record protocol-required data for each enrolled subject. CRF design follows the Statistical Analysis Plan and CDISC CDASH standards so that data captured maps cleanly to SDTM datasets for regulatory submission. What the regulation says FDA 21 CFR Part 11 (electronic records and signatures), ICH E6(R3) [GCP](/terms/gcp), and CDISC standards (CDASH for collection, SDTM for submission). FDA requires SDTM for NDA/BLA and increasingly for device [PMA](/terms/pma) submissions. ## What this means in practice CRF design is one of the highest-leverage activities in trial planning, a poorly designed CRF generates queries, slows database lock, and impairs analysis. Source-data verification ( [SDV](/terms/sdv)) practices have shifted toward [risk-based monitoring](/terms/risk-based-monitoring) rather than 100% SDV. Common pitfalls - • Letting clinical operations design the CRF without statistician and data-management input. - • Capturing free-text where coded fields would suffice, generates downstream cleaning burden. ## 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)[ 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) ### 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 CDISC· 1 eCFR· 1 NIH· 1 1. [1 CDISC Standards Verified CDISC · cdisc.org ](https://www.cdisc.org/standards) 2. [2 FDA 21 CFR Part 11 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11) 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. [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 CRF Sources 3 Updated 5/9/2026 [Compare with another term](/compare?a=case-report-form) Learn in 60 seconds Card Lesson Quiz Structured paper or electronic forms used to capture protocol-required data for each enrolled subject. - · CRF design is one of the highest-leverage activities in trial planning, a poorly designed CRF generates queries, slows database lock, and impairs analysis. - · Source-data verification (SDV) practices have shifted toward risk-based monitoring rather than 100% SDV. - · CRF design follows the Statistical Analysis Plan and CDISC CDASH standards so that data captured maps cleanly to SDTM datasets for regulatory submission. Remember this Watch out: Letting clinical operations design the CRF without statistician and data-management input. Related terms - [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp) - [ALCOA+ ](/terms/alcoa-plus) - [Source Data Verification(SDV) ](/terms/sdv) - [Trial Master File(TMF) ](/terms/trial-master-file) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Electronic Data Capture(EDC) ](/terms/edc) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Clinical Investigation Plan(CIP) ](/terms/cip) - [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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