GCP Considerations: The Investigator’s Brochure (IB)
Guidance on the Purpose, Design and Management of an Investigator’s Brochure (IB): EU & UK
Questions are often raised by clinical study team members regarding the use of an Investigator’s Brochure (IB), an IB supplemented by a Summary of Product Characteristics (SmPC), or an SmPC to support products that are already registered. This requires further elaboration and discussion in order to provide meaningful and specific guidance.
This short report was produced in response to such questions and provides Guidance on the purpose, design and management of an Investigator’s Brochure (IB) with particular emphasis on the UK requirements.
Please click on the image above to download a complimentary copy of the GCP Considerations report on the Investigator’s Brochure (IB).
Please note that you will need to a have a ‘PDF Reader ‘ installed to view the report.
Last Updated on: 12th March 2011
Reason for Update:
- Updated the ICH E6 links to capture the recent changes to the ICH Website (i.e. change of web address)
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