This project is a proof of concept investigating the use of Linked Data for validation and submission of non-clinical study data submitted to the FDA. The work is comprised of two initiatives:

  1. Modeling and validating SEND (nonclinical) data
  2. FDA Submission Criteria

This project deconstructs FDA SEND rules and submission criteria into their constituent components. Each rule is interpreted, transformed to its corresponding SHACL shape, applied to example data to generate a validation report, then confirmed independently using SPARQL.

When both study sponsors and regulatory agencies use common data models and rules across the entire data lifecycle, data quality is greatly improved and the submission and approval process is more efficient. Linked Data’s high precision leads to better data, better analysis, and better medicines for patients.

Work in Progress!

The project is in active development with many pages under construction. Please contact us to report errors and omissions - and to join our team of volunteers!