Study Data Validation and Submission Conformance
This project replaces its predecessor "Going Translational With Linked Data (GoTWLD)", extending existing work in both clinical and preclinical areas by further developing the data models and instance data conversion. The project will include modeling FDA Technical Rejection Criteria to facilitate submission of data to the FDA. To view the project documentation page click here.
• Conformance errors for study data submissions to the FDA can be largely decreased using an ontology-based Linked Data model, including validation using Shapes Constraint Language (SHACL).
• The proof of concept will demonstrate creation of highly-compliant, high-quality preclinical and clinical study data for submissions, using a much more automated process than is currently available. Costs for data review, validation, and re-work will be greatly reduced.
• Separation of the results (instance) data from the standards data and metadata results in a version-free graph data structure for nonclinical studies and clinical trials results. CDISC-compliant data for submissions will be created by mapping the results data to the standards. Costs for recoding between CDISC versions will be drastically reduced.
• Metadata for submissions packages to the FDA can be standardised, validated, and semi-automated.
• The project provides a gateway for Knowledge Graph technology to support the FDA's Technology and Modernisation Action Plan (TMAP)
F.A.I.R. Principles will be followed with all work made available on GitHub, including a comprehensive website for documentation, explanation, and resources (https://phuse-org.github.io/SENDConform/ - currently under early construction, URL subject to change). Web Protégé will be used for collaborative ontology development.
• Participants with expertise in RDF creation and querying, including ontologies, SHACL, and related tools.
• CDISC SDTM and SEND terminology and domain knowledge.
• Participation from the FDA; specifically a sample or dummy eCTD file to support development of the prototype.
Team members from the GoTWLD project will roll-over into the new project. With involvement from the FDA, and potentially academia, the project hopes to avoid the lack of staff resources which have hampered past initiatives.
|Tim Williams||Co-lead||UCB Biosciencesemail@example.com|
|Giuseppe Di Monaco||Member||UCB|
|Lilliam Rosario||FDA||Lutz Weber||Member||Ontochem|
|Mark A Musen||Stanford University|
|Nicholas Jeremy Nugent||Industry|
|Tom Van der Spiegel||Member||JNJ|
Provide project updates in this section.
Date: Description of Update
Objectives and Timelines
|Supporting Ontologies||February 2021|
|Technical Rejection Criteria Proof of Concept||February 2021|
|Submission Metadata Collection Proof of Concept||February 2021|
|Documentation and Resources (website)||February 2021|
|Project Conclusion||February 2021|
This section can document project activities or serve as a jumping off point to other pages in the project.