Investigator Brochure
Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations.
Definition
An Investigator Brochure (IB) is a comprehensive document summarizing all available clinical and nonclinical data on an investigational device, prepared by the sponsor and provided to every clinical investigator participating in an IDE study. The IB describes the device, its intended use, manufacturing summary, preclinical and prior clinical experience, known and potential risks (including anticipated adverse events with frequency estimates), guidance for managing adverse events, and a summary of the protocol's hypothesis and design. The IB is the reference document against which UADE determinations are made and must be updated as new safety information emerges.What this means in practice
The IB plays a load-bearing role in clinical trial safety governance. It defines the anticipated risk profile, anything outside that profile may qualify as a UADE. ISO 14155 requires sponsors to provide investigators with the equivalent of an IB. Sponsors should treat the IB as a living document with controlled-revision procedures, annual updates at minimum, and prompt updates whenever safety information materially changes.Examples
- Before a clinical trial for a new cardiac stent begins, the sponsor compiles an Investigator Brochure detailing all preclinical test results, prior human experience, and expected adverse events for the device.
- During the study, an unexpected serious adverse event occurs; the investigator refers to the Investigator Brochure to determine if the event falls outside the device's anticipated risk profile and requires expedited reporting as a UADE.
- The Investigator Brochure is updated by the sponsor midway through the trial to incorporate new safety information learned from ongoing animal studies, ensuring all investigators have the most current risk data.
- •Treating the IB as a one-time submission, failing to update it as safety data emerges weakens UADE determinations and IRB confidence.
- •Confusing the IB with the protocol, the protocol describes how the study is conducted; the IB describes what is known about the device.
- •Omitting frequency estimates for anticipated adverse events, without them, UADE classification is much harder to defend.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsDeparture from the approved clinical investigation plan.
Voluntary, informed agreement to participate in research after disclosure of risks and benefits.
FDA authorization to use an investigational device in a clinical study.
Good clinical practice for clinical investigations of medical devices.
Clinical Trials & Evidence
· From this learning pathTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Small clinical study evaluating initial safety, usability, and design parameters of an investigational device.
Where this term appears across MedTech Terms.
- Clinical Trials & EvidenceLesson 8 of 18
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Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 121 CFR 812.25 - IDE Application ContentTier 1 VerifiedeCFRecfr.gov
- 2ISO 14155:2020Tier 1 VerifiedISOiso.org
- 3ClinicalTrials.govTier 3 VerifiedNIHclinicaltrials.gov
Inline markers like [1] jump to the matching reference above.