Module 12 2019

Exceptions to Standardized Study Data Submissions

“Data standards are evolving at different rates for varying study types, and they are not being adopted at the same rate throughout the FDA”

Refer to the Study Data Standards Resources Web page:

• http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm

This site will describe:

•Which types of studies should be submitted in standardized format •Which offices are accepting standardized study data submissions

The Organisation for Professionals in Regulatory Affairs