Course Description

During the course of clinical research, the Investigator’s Brochure (IB) is the data repository for an investigational product; effectively this is the product’s “label” during the investigational stage. The IB is a dynamic document which changes as the information changes. It is critical in clinical research as physicians and Institutional Review Boards (IRBs) refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing, manufacturing, and clinical and nonclinical study results. To facilitate the transfer of information, the IB must be concise, well-written, and provide a summary for a physician to quickly reference. ICH GCP E6 Guideline provides an outline of the requirements, how companies address these requirements and the degree of information provided differs. The required contents will be reviewed in this web seminar. Tips and techniques for effective writing, including pulling together the needed information, working with a team, and writing a summary will also be discussed.

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Learning Objectives

• Identify who contributes to the IB
• Determine the timing of construction of the IB
• List IB requirements per the ICH GCP E6 Guideline and effectively implement these requirements
• Perform a research literature review for the background section, and reuse it in other documents
• Examine how a Target Product Profile or Draft Package Insert can be drafted based on the IB
• Examine approaches that support physician’s reading of the IB: The IB Summary
• Determine when the IB should be updated, by whom, and what documents the update effects

Who Should Attend

• Regulatory Affairs Professionals
• Medical Writers
• Clinical Research Professionals
• Research and Development Personnel

Instructor

Cheryl Vitow

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.