Creation and Maintenance of an Investigator Brochure

The amended Regulations (SI 2006/1928) state that the Sponsor of a clinical trial is responsible for the Investigator Brochure (IB) and shall ensure that the trial IB presents the information it contains in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial; and shall validate and update the investigator’s brochure at least once a year.

The IB provides the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. The IB also provides insight to support the clinical management of the study subjects during the course of the clinical trial.

The purpose of this SOP is to describe when an IB is required, the minimum content required and when to update the IB.

SOP: Creation and Maintenance of an Investigator Brochure (.pdf 7MB)

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