Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template

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Date Sep 20, 2016
Time 12:00 PM EDT
Cost $299.00
Understanding & Implementing The New NIH & FDA Draft Clinical Trial Protocol Template
Date: September 20, 2016
Time: 1:00pm-2:30pm, EDT US
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

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.  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

Who Should Attend:

This course will be of benefit to anyone who is involved in drafting, reviewing, amending, and submitting clinical protocols for Phase II and/or Phase III clinical studies (e.g. investigators; clinical research staff including Medical Writers, Study Managers etc.; Quality Assurance staff and Regulatory Affairs staff who review protocols).


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