The Phase 1 data elements and controlled terminology have been published in the 2017 FRN. This is a high-level conceptual model covering the phase 1 groups/domains. The model is represented as a Unified Modeling Language (UML) Class diagram/data model. FDA is publishing this conceptual model to help provide context to the list of data elements and represent the relationships between the concepts. It is to only promote understanding of the domain. It is important to note that this is a high-level conceptual model; it is not a logical data model.
- For additional information/support from PQ/CMC Team, please contact PQ-CMC@fda.hhs.gov.