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.

Why it matters

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.

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.

Sources

21 CFR 812.25 - IDE Application Content · eCFR
ISO 14155:2020 · ISO
ClinicalTrials.gov · NIH

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