MedTech Terms
    The authoritative reference
    All pathsClinical · RA · Biostats · 18 terms

    Clinical Trials & Evidence

    The vocabulary of medical device clinical investigation, from IDE and IRB through endpoints, GCP, and real-world evidence.

    Your progress
    0 of 18 lessons complete · up next: Investigational Device Exemption
    Start path
    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Finished the path? Test yourself with a quiz tailored to these 18 terms.

    Take the Clinical Trials & Evidence quiz