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Clinical Trials & Evidence

Name: Clinical Trials & Evidence
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The vocabulary of medical device clinical investigation, from IDE and IRB through endpoints, GCP, and real-world evidence.

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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

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.
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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

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.
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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.
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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.
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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

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.
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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

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.
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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.
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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.
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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.
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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.
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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

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.
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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

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.

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Clinical Trials & Evidence

Investigational Device Exemption(IDE)

IDE Supplement

IDE Annual Progress Report

Institutional Review Board(IRB)

Informed Consent

Good Clinical Practice(GCP)

ISO 14155

Investigator Brochure(IB)

Protocol Deviation

Primary and Secondary Endpoints

Surrogate Endpoint

Adverse Event(AE)

Feasibility Study

Pivotal Trial

Adaptive Trial Design

Risk-Based Monitoring(RBM)

Clinical Evaluation Report(CER)

Real-World Evidence(RWE)