Stay Ahead of the Curve: How to implement New FDA Recommendation Study Data Standardization Plan (SDSP) in your organization?

Aakar Shah1 and Heather Riley2
1Nektar Therapeutics, 2Pfizer


Abstract

The Study Data Standardization Plan (SDSP) is a living document and assists the Food and Drug Administration (FDA) in identifying potential data standardization issues early in the development program. As the FDA has begun to request sponsors to provide a SDSP, it may not be that long until this new FDA recommendation becomes a new FDA requirement. Initial recommendations have been provided through a PhUse sponsored limited duration team. We have taken these recommendations and expanded the tools and process necessary to help the sponsor implement the SDSP within their organization.