References and Resources

FDA

Technical Rejection Criteria

SEND Validation

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

• The eCTD Backbone File Specification for Study Tagging Files (PDF)

• Providing Regulatory Submissions In Electronic Format - Standardized study Data (PDF)

CDISC

• SEND information on the CDISC website

SHACL

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.

• W3C SHACL Spec

• Designing Resusable SHACL Shapes and Implement a Linked Data Validation Pipeline

Ontology

• Web Protege Wiki

Project Publications

• Building a F.A.I.R. Foundation for Pharma (Section: Roofshot 3: A Linked Data Approach to SEND Conformance )