Importance of Clinical Investigator´s Brochure (IB)
This intuitive course on Importance of Clinical Investigator´s Brochure serves up key explications and insight as to why it is important to provide the investigator with crucial information supporting your medical device´s use in a clinical investigation. This document along with the instructional training regarding content that you provide will directly impact the establishment of trust and cooperation with your investigator.
A large section of this course is dedicated to the content and level of detail that the investigator’s brochure must present and includes discussion on the role of instructions for use and product training, balancing the information within this document and protecting a company’s intellectual property as well as how risk management pulls investigational device information and preclinical/clinical data together to provide a compelling argument to the investigator as to the safety of the investigational device.
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Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend the purpose and function of the investigator’s brochure and how it impacts the ongoing relationship with your investigator
- Determine the content and level of detail the investigator’s brochure must exhibit.
- Recognize the requirement of keeping the investigator brochure current and how a good document control system and risk management system allows you to accomplish this requirement
- Describe key investigator’s brochure terminology.
Monitors, clinical trial assistants, study coordinators, investigators in need for understanding the content of an investigator´s brochure (IB).
Basic understanding of GCP (ID 42) with a knowledge of the overall organization and documentation of a clinical investigation as well as an understanding on the logistics to implement these documents to the clinical investigation site (ID 43, ID 46, ID 48).