Sample Investigator's Brochure Template

Version No: Page 1 of 6
Confidential
This template has been devised to be consistent with ISO 141555-2011 GCP for medical devices
Background for template:
The purpose of the investigator’s brochure (IB) is to provide the principal investigator(s) with
sufficient safety or performance data from pre-clinical investigation(s) and/or clinical
investigation(s) to justify human exposure to the investigational device specified in the clinical
investigational protocol. The IB shall be updated throughout the course of the clinical
investigation as significant new information becomes available. The principal investigator(s)
shall acknowledge the receipt of the IB and all subsequent amendments and keep all
information confidential.
Document Reference Number:
Name of Investigational Device:
Sponsor Name:
Sponsor Address:
Version No:
Date:
Revision History
Version Number
Date
_________________________________________ ______________
Authorised company signatory Company Name Date
This document contains confidential information and proprietary information and may not be
copied or reproduced in whole or part without the written permission of ___________
Investigator’s Brochure (IB) template
for Device XXX
Page 1/6
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Sample Investigator's Brochure Template PDF

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