Importance of Clinical Investigator´s Brochure (IB)

This course focuses on clinical Investigator’s Brochures (IBs) and offers key insight into the importance of providing investigators with information supporting a medical device’s use in clinical investigations. This document, along with personal instructional training, directly impacts the establishment of trust and cooperation with investigators.

A large portion of this course is dedicated to detailing the type of content an IB must present to investigators. It covers the following topics:

• A discussion on the role of Instructions for Use (IFU) and product training
• The importance of protecting company intellectual property
• How risk management uses investigational device information and pre-clinical and clinical data to form compelling arguments regarding the safety of investigational devices