Technical Rejection Criteria
Information can be found on the FDA Website: https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources
- FDA Study Validator Rules (Excel)
- Validator Rules, FDA source: https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources (then follow “Validator Rules” spreadsheet)
- Technical Rejection Criteria (PDF)
- FDA Source: https://www.fda.gov/media/100743/download
- Providing Regulatory Submissions In Electronic Format - Standardized study Data (PDF)
An introduction to SHACL is beyond the scope of this project. The following resources may be helpful:
Validating RDF Data. Website version of the excellent book.
What is SHACL?. Articles and Webinars at TopQuadrant.
- Data Validation and SHACL. Webinar by Stardog Union illustrating their implementation of SHACL and their Stardog Studio environment.
- Designing Resusable SHACL Shapes and Implement a Linked Data Validation Pipeline
OntologyAdd: References about ontology and ontology development.
Project PublicationsA list of publications related to the project.
- Building a F.A.I.R. Foundation for Pharma (Section: Roofshot 3: A Linked Data Approach to SEND Conformance )