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. While ICH E6 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.
- Identify who contributes to the IB
- Determine the timing of construction of the IB
- Detail IB requirements per ICH E6 and effectively implement these requirements
- Conduct literature for the background section and re-use these in other documents
- Examine how a Target Product Profile or Draft Package Insert can be drafted based on the IB
- Get a physician to read an IB: The IB Summary
- Determine when the IB should be updated, by whom, and what documents the update effects
- Regulatory Affairs Professionals
- Medical Writers
- Clinical Research Professionals
- Research and Development Personnel
Meredith Brown-Tuttle, R.A.C.
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3 hours; 12:00 - 3:00 p.m. Eastern
September 26, 2011
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471