The National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are suggesting a standardized format for protocols utilized in conducting Phase II and III clinical trials under an IND (Investigational New Drug) or IDE (Investigational Device Exemption). Investigators applying for NIH grants must use this template. However, since FDA is involved, they are suggesting that sponsors and investigators also follow the template and retain the sections in the order provided. Since the template was revised last year, there are subtle and nuanced changes that you should understand before applying to your studies.
This course will discuss the template and review the various sections to provide course attendees with an understanding of the required format as well as preparing for implementation.
During this interactive, 90-minute session, you will learn:
- Important pieces of the template, and how it differs from conventional protocols
- How to interpret the template requirements, and marry them to your current efforts
- Important pitfalls to avoid and risk mitigation strategies
- Implementation of the template and strategies for continuous improvement