The data definition file describes the format and content of the submitted datasets.
Source: Study Data Specifications (FDA)
Glossary
Data Definition File
Resources
Take advantage of the knowledge and best practices gained from more than 20 years of research, innovation and development for the health and life sciences sectors.
Glossary
The Life Sciences glossary with terminology, acronyms, for regulatory, quality, compliance, clinical trials, and pharmacovigilance software.
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