Importance of Clinical Investigator´s Brochure (IB)
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
ID: 117
85 minutes
2 modules
Learning Objectives
Upon successfully completing this course, learners will be able to:
- Comprehend the purpose and function of an IB and how it impacts the ongoing relationship with investigators
- Determine the content and level of detail an IB must exhibit
- Recognize the importance of keeping an IB current and how good document control and risk management systems can facilitate this requirement
- Describe key IB terminology
Who Should Enroll
Clinical research associates (monitors), senior clinical research associates, clinical project and compliance managers, clinical quality associates and managers, clinical affairs directors, regulatory affairs managers, quality assurance managers and engineers, notified body and lead auditors, and regulator and R&D engineers are all welcome to participate in this course.
Prerequisite Knowledge
The following material is required:
- A basic understanding of the overall organization and documentation of a clinical investigation
- Introduction to Good Clinical Practice (ID 42)
- Introduction to Medical Device and Clinical Investigation Planning (ID 43)
- Ethics Committee (EC)/Institutional Review Board Requirements (ID 46)
- Initiation Visit (ID 48)