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Your progress 0 of 18 lessons complete · up next: Investigational Device Exemption [Start path](/terms/ide?from=clinical-trials-and-evidence) 1. 1 [ Clinical & Trials ## Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. Why this term here: Start here: the FDA authorization that lets a significant-risk device be studied in humans. ](/terms/ide?from=clinical-trials-and-evidence)Mark done 2. 2 [ Clinical & Trials ## IDE Supplement Amendment to an approved Investigational Device Exemption for protocol or device changes. Why this term here: How you modify a live IDE without pausing enrollment. ](/terms/ide-supplement?from=clinical-trials-and-evidence)Mark done 3. 3 [ Clinical & Trials ## IDE Annual Progress Report Annual report sponsors must submit to FDA summarizing the progress of an approved IDE study, including enrollment, deviations, and adverse events. Why this term here: The recurring reporting obligation that keeps the IDE in good standing. ](/terms/ide-annual-report?from=clinical-trials-and-evidence)Mark done 4. 4 [ Clinical & Trials ## Institutional Review Board(IRB) Board that reviews and approves human-subjects research at an institution. Why this term here: Local ethics oversight, distinct from FDA. Required at every US site. ](/terms/irb?from=clinical-trials-and-evidence)Mark done 5. 5 [ Clinical & Trials ## Informed Consent Voluntary, informed agreement to participate in research after disclosure of risks and benefits. Why this term here: The subject-facing protection that every study document flows into. ](/terms/informed-consent?from=clinical-trials-and-evidence)Mark done 6. 6 [ Commercialization ## Good Clinical Practice(GCP) International quality standard for designing and conducting clinical trials. Why this term here: The global umbrella practice standard for how a trial is conducted. ](/terms/gcp?from=clinical-trials-and-evidence)Mark done 7. 7 [ Standards ## ISO 14155 Good clinical practice for clinical investigations of medical devices. Why this term here: The device-specific implementation of GCP: read it if you sponsor a device trial. ](/terms/iso-14155?from=clinical-trials-and-evidence)Mark done 8. 8 [ Clinical & Trials ## Investigator Brochure(IB) Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. Why this term here: The single source of truth on device characteristics for investigators. ](/terms/investigator-brochure?from=clinical-trials-and-evidence)Mark done 9. 9 [ Clinical & Trials ## Protocol Deviation Departure from the approved clinical investigation plan. Why this term here: What counts, what must be reported, and what hurts data integrity. ](/terms/protocol-deviation?from=clinical-trials-and-evidence)Mark done 10. 10 [ Clinical & Trials ## Primary and Secondary Endpoints The pre-specified outcomes that determine trial success (primary), provide supporting evidence (secondary), or generate hypotheses (exploratory). Why this term here: The hierarchy that determines what your trial actually proves. ](/terms/primary-secondary-endpoint?from=clinical-trials-and-evidence)Mark done 11. 11 [ Clinical & Trials ## Surrogate Endpoint Biomarker or intermediate outcome used as a substitute for a clinical endpoint in regulatory decisions. Why this term here: When a proxy measurement is acceptable to regulators, and when it isn't. ](/terms/surrogate-endpoint?from=clinical-trials-and-evidence)Mark done 12. 12 [ Clinical & Trials ## Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. Why this term here: Detection, classification, and reporting duties during a study. ](/terms/adverse-event?from=clinical-trials-and-evidence)Mark done 13. 13 [ Clinical & Trials ## Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. Why this term here: The small early study that de-risks design before a pivotal. ](/terms/feasibility-study?from=clinical-trials-and-evidence)Mark done 14. 14 [ Clinical & Trials ## Pivotal Trial Definitive clinical study designed to establish safety and effectiveness for marketing authorization. Why this term here: The confirmatory study that supports a PMA or De Novo submission. ](/terms/pivotal-trial?from=clinical-trials-and-evidence)Mark done 15. 15 [ Clinical & Trials ## Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. Why this term here: Designs that pre-plan modifications based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)Mark done 16. 16 [ 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. Why this term here: How modern trials focus monitoring effort where risk actually is. ](/terms/risk-based-monitoring?from=clinical-trials-and-evidence)Mark done 17. 17 [ Clinical & Trials ## Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. Why this term here: Where the clinical evidence gets summarized for EU MDR conformity. ](/terms/cer?from=clinical-trials-and-evidence)Mark done 18. 18 [ Clinical & Trials ## Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. Why this term here: How post-market data can substitute for or supplement classic trials. ](/terms/real-world-evidence?from=clinical-trials-and-evidence)Mark done Finished the path? Test yourself with a quiz tailored to these 18 terms. [Take the Clinical Trials & Evidence quiz](/quiz?path=clinical-trials-and-evidence) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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