---
title: "Clinical &amp; Trials Terms - MedTech Terms"
description: "Clinical evidence, investigations, and human-factors studies. 49 vendor-neutral definitions with primary-source citations."
lang: en
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            "name": "Adaptive Trial Design",
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            "@type": "DefinedTerm",
            "name": "Analytical Sensitivity",
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            "@type": "DefinedTerm",
            "name": "Bayesian Trial Design",
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            "@type": "DefinedTerm",
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            "name": "Case Report Form",
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          {
            "@type": "DefinedTerm",
            "name": "Clinical Evaluation Plan",
            "alternateName": "CEP",
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            "@type": "DefinedTerm",
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            "@type": "DefinedTerm",
            "name": "Clinical Investigation Plan",
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            "name": "Data Safety Monitoring Board",
            "alternateName": "DSMB",
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            "@type": "DefinedTerm",
            "name": "Decentralized Clinical Trial",
            "alternateName": "DCT",
            "url": "https://medtechterms.com/terms/decentralized-clinical-trial",
            "termCode": "decentralized-clinical-trial"
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          {
            "@type": "DefinedTerm",
            "name": "Early Feasibility Study",
            "alternateName": "EFS",
            "url": "https://medtechterms.com/terms/efs",
            "termCode": "efs"
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          {
            "@type": "DefinedTerm",
            "name": "Electronic Data Capture",
            "alternateName": "EDC",
            "url": "https://medtechterms.com/terms/edc",
            "termCode": "edc"
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          {
            "@type": "DefinedTerm",
            "name": "Feasibility Study",
            "url": "https://medtechterms.com/terms/feasibility-study",
            "termCode": "feasibility-study"
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          {
            "@type": "DefinedTerm",
            "name": "First-in-Human Study",
            "alternateName": "FIH",
            "url": "https://medtechterms.com/terms/fih",
            "termCode": "fih"
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          {
            "@type": "DefinedTerm",
            "name": "Human Factors Engineering",
            "alternateName": "HFE",
            "url": "https://medtechterms.com/terms/human-factors",
            "termCode": "human-factors"
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          {
            "@type": "DefinedTerm",
            "name": "ICH E6 Good Clinical Practice",
            "alternateName": "GCP",
            "url": "https://medtechterms.com/terms/ich-gcp",
            "termCode": "ich-gcp"
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          {
            "@type": "DefinedTerm",
            "name": "IDE Annual Progress Report",
            "url": "https://medtechterms.com/terms/ide-annual-report",
            "termCode": "ide-annual-report"
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            "@type": "DefinedTerm",
            "name": "IDE Supplement",
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            "@type": "DefinedTerm",
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            "@type": "DefinedTerm",
            "name": "Investigational Device Exemption",
            "alternateName": "IDE",
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            "@type": "DefinedTerm",
            "name": "Investigator Brochure",
            "alternateName": "IB",
            "url": "https://medtechterms.com/terms/investigator-brochure",
            "termCode": "investigator-brochure"
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          {
            "@type": "DefinedTerm",
            "name": "Investigator-Initiated Trial",
            "alternateName": "IIT",
            "url": "https://medtechterms.com/terms/investigator-initiated-trial",
            "termCode": "investigator-initiated-trial"
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            "@type": "DefinedTerm",
            "name": "Limit of Detection / Limit of Quantitation",
            "alternateName": "LoD / LoQ",
            "url": "https://medtechterms.com/terms/lod-loq",
            "termCode": "lod-loq"
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            "@type": "DefinedTerm",
            "name": "Lost to Follow-up",
            "url": "https://medtechterms.com/terms/lost-to-followup",
            "termCode": "lost-to-followup"
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            "@type": "DefinedTerm",
            "name": "Master Protocol (Basket / Umbrella / Platform)",
            "url": "https://medtechterms.com/terms/master-protocol",
            "termCode": "master-protocol"
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          {
            "@type": "DefinedTerm",
            "name": "Minimal Clinically Important Difference",
            "alternateName": "MCID",
            "url": "https://medtechterms.com/terms/mcid",
            "termCode": "mcid"
          },
          {
            "@type": "DefinedTerm",
            "name": "Non-Inferiority Trial",
            "url": "https://medtechterms.com/terms/non-inferiority-trial",
            "termCode": "non-inferiority-trial"
          },
          {
            "@type": "DefinedTerm",
            "name": "Performance Study (IVDR)",
            "url": "https://medtechterms.com/terms/ivdr-performance-study",
            "termCode": "ivdr-performance-study"
          },
          {
            "@type": "DefinedTerm",
            "name": "Pivotal Trial",
            "url": "https://medtechterms.com/terms/pivotal-trial",
            "termCode": "pivotal-trial"
          },
          {
            "@type": "DefinedTerm",
            "name": "Pragmatic Trial",
            "url": "https://medtechterms.com/terms/pragmatic-trial",
            "termCode": "pragmatic-trial"
          },
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            "@type": "DefinedTerm",
            "name": "Primary and Secondary Endpoints",
            "url": "https://medtechterms.com/terms/primary-secondary-endpoint",
            "termCode": "primary-secondary-endpoint"
          },
          {
            "@type": "DefinedTerm",
            "name": "Propensity Score Methods",
            "url": "https://medtechterms.com/terms/propensity-score",
            "termCode": "propensity-score"
          },
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            "@type": "DefinedTerm",
            "name": "Protocol Deviation",
            "url": "https://medtechterms.com/terms/protocol-deviation",
            "termCode": "protocol-deviation"
          },
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            "@type": "DefinedTerm",
            "name": "Real-World Data",
            "alternateName": "RWD",
            "url": "https://medtechterms.com/terms/rwd",
            "termCode": "rwd"
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            "@type": "DefinedTerm",
            "name": "Real-World Evidence",
            "alternateName": "RWE",
            "url": "https://medtechterms.com/terms/real-world-evidence",
            "termCode": "real-world-evidence"
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            "@type": "DefinedTerm",
            "name": "Risk-Based Monitoring",
            "alternateName": "RBM",
            "url": "https://medtechterms.com/terms/risk-based-monitoring",
            "termCode": "risk-based-monitoring"
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          {
            "@type": "DefinedTerm",
            "name": "Sample Size and Statistical Power",
            "url": "https://medtechterms.com/terms/sample-size-power",
            "termCode": "sample-size-power"
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            "@type": "DefinedTerm",
            "name": "Serious Adverse Event",
            "alternateName": "SAE",
            "url": "https://medtechterms.com/terms/sae",
            "termCode": "sae"
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            "@type": "DefinedTerm",
            "name": "Sham Control",
            "url": "https://medtechterms.com/terms/sham-control",
            "termCode": "sham-control"
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            "@type": "DefinedTerm",
            "name": "Source Data Verification",
            "alternateName": "SDV",
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            "@type": "DefinedTerm",
            "name": "Surrogate Endpoint",
            "url": "https://medtechterms.com/terms/surrogate-endpoint",
            "termCode": "surrogate-endpoint"
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            "@type": "DefinedTerm",
            "name": "Trial Master File",
            "alternateName": "TMF",
            "url": "https://medtechterms.com/terms/trial-master-file",
            "termCode": "trial-master-file"
          },
          {
            "@type": "DefinedTerm",
            "name": "Unanticipated Adverse Device Effect",
            "alternateName": "UADE",
            "url": "https://medtechterms.com/terms/uade",
            "termCode": "uade"
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            "@type": "DefinedTerm",
            "name": "Use Error",
            "url": "https://medtechterms.com/terms/use-error",
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---

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# Clinical & Trials

Clinical evidence, investigations, and human-factors studies.

49 terms [Filter in glossary](/terms?cat=Clinical%20%26%20Trials)

## All Clinical & Trials terms

-   [Adaptive Trial Design ](/terms/adaptive-trial)
-   [Adverse Event(AE) ](/terms/adverse-event)
-   [ALCOA+ ](/terms/alcoa-plus)
-   [Analytical Sensitivity ](/terms/analytical-sensitivity)
-   [Bayesian Trial Design ](/terms/bayesian-trial)
-   [Blinding and Masking ](/terms/blinding)
-   [Case Report Form(CRF) ](/terms/case-report-form)
-   [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan)
-   [Clinical Evaluation Report(CER) ](/terms/cer)
-   [Clinical Investigation Plan(CIP) ](/terms/cip)
-   [Composite Endpoint ](/terms/composite-endpoint)
-   [Data Safety Monitoring Board(DSMB) ](/terms/dsmb)
-   [Decentralized Clinical Trial(DCT) ](/terms/decentralized-clinical-trial)
-   [Early Feasibility Study(EFS) ](/terms/efs)
-   [Electronic Data Capture(EDC) ](/terms/edc)
-   [Feasibility Study ](/terms/feasibility-study)
-   [First-in-Human Study(FIH) ](/terms/fih)
-   [Human Factors Engineering(HFE) ](/terms/human-factors)
-   [ICH E6 Good Clinical Practice(GCP) ](/terms/ich-gcp)
-   [IDE Annual Progress Report ](/terms/ide-annual-report)
-   [IDE Supplement ](/terms/ide-supplement)
-   [Informed Consent ](/terms/informed-consent)
-   [Institutional Review Board(IRB) ](/terms/irb)
-   [Intent-to-Treat vs Per-Protocol(ITT / PP) ](/terms/itt-pp)
-   [Investigational Device Exemption(IDE) ](/terms/ide)
-   [Investigator Brochure(IB) ](/terms/investigator-brochure)
-   [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial)
-   [Limit of Detection / Limit of Quantitation(LoD / LoQ) ](/terms/lod-loq)
-   [Lost to Follow-up ](/terms/lost-to-followup)
-   [Master Protocol (Basket / Umbrella / Platform) ](/terms/master-protocol)
-   [Minimal Clinically Important Difference(MCID) ](/terms/mcid)
-   [Non-Inferiority Trial ](/terms/non-inferiority-trial)
-   [Performance Study (IVDR) ](/terms/ivdr-performance-study)
-   [Pivotal Trial ](/terms/pivotal-trial)
-   [Pragmatic Trial ](/terms/pragmatic-trial)
-   [Primary and Secondary Endpoints ](/terms/primary-secondary-endpoint)
-   [Propensity Score Methods ](/terms/propensity-score)
-   [Protocol Deviation ](/terms/protocol-deviation)
-   [Real-World Data(RWD) ](/terms/rwd)
-   [Real-World Evidence(RWE) ](/terms/real-world-evidence)
-   [Risk-Based Monitoring(RBM) ](/terms/risk-based-monitoring)
-   [Sample Size and Statistical Power ](/terms/sample-size-power)
-   [Serious Adverse Event(SAE) ](/terms/sae)
-   [Sham Control ](/terms/sham-control)
-   [Source Data Verification(SDV) ](/terms/sdv)
-   [Surrogate Endpoint ](/terms/surrogate-endpoint)
-   [Trial Master File(TMF) ](/terms/trial-master-file)
-   [Unanticipated Adverse Device Effect(UADE) ](/terms/uade)
-   [Use Error ](/terms/use-error)

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