--- title: "IB, Investigator Brochure | MedTech Terms" description: "Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/investigator-brochure#term", "name": "Investigator Brochure", "alternateName": "IB", "description": "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. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Investigator Brochure [All terms](/terms) Clinical & Trials [Clinical Evidence](/ecosystems/clinical-evidence)IB # Investigator Brochure Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## 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](/terms/ide) study. The IB describes the device, its [intended use](/terms/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](/terms/uade) determinations are made and must be updated as new safety information emerges. What the regulation says 21 CFR 812.25(g) requires the [IDE](/terms/ide) application to include an investigator brochure. [ISO 14155](/terms/iso-14155):2020 §6.3 and Annex C define IB content expectations for international device investigations. ICH [GCP](/terms/gcp) E6(R3) requires IBs for drug and biological product investigations with similar content. ## 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](/terms/uade). [ISO 14155](/terms/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. Common pitfalls - • 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. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Clinical & Trials Protocol Deviation Departure from the approved clinical investigation plan. ](/terms/protocol-deviation)[ Clinical & Trials Informed Consent Voluntary, informed agreement to participate in research after disclosure of risks and benefits. ](/terms/informed-consent)[ Clinical & Trials Investigational Device Exemption(IDE) FDA authorization to use an investigational device in a clinical study. ](/terms/ide)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### Clinical Trials & Evidence · From this learning path [ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?from=clinical-trials-and-evidence)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer?from=clinical-trials-and-evidence)[ Clinical & Trials Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. ](/terms/feasibility-study?from=clinical-trials-and-evidence) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 8 of 18 Ecosystems (1) - [Clinical Evidence](/ecosystems/clinical-evidence) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 ISO· 1 NIH· 1 1. [1 21 CFR 812.25 - IDE Application Content Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812/subpart-B/section-812.25) 2. [2 ISO 14155:2020 Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) 3. [3 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym IB Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=investigator-brochure) Learn in 60 seconds Card Lesson Quiz Compilation of clinical and nonclinical information on an investigational device given to clinical investigators, establishes what's 'anticipated' for UADE determinations. - · 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. Remember this Watch out: Treating the IB as a one-time submission, failing to update it as safety data emerges weakens UADE determinations and IRB confidence. Related terms - [Investigational Device Exemption(IDE) ](/terms/ide) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [ISO 14155 ](/terms/iso-14155) - [ICH E6(R3) Good Clinical Practice(E6(R3)) ](/terms/ich-e6-r3) - [Protocol Deviation ](/terms/protocol-deviation) - [Informed Consent ](/terms/informed-consent) - [Clinical Investigation Plan(CIP) ](/terms/cip) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [IDE Annual Progress Report ](/terms/ide-annual-report) - [Feasibility Study ](/terms/feasibility-study) - [Investigator-Initiated Trial(IIT) ](/terms/investigator-initiated-trial) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [General Safety and Performance Requirements (IVDR)(GSPR) ](/terms/ivdr-gspr) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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