Study Data Validation and Submission Conformance

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Project Overview

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.

Value Proposition
• 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 ( - currently under early construction, URL subject to change). Web Protégé will be used for collaborative ontology development.

Project Dependencies

• 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.

Project Leads

Tim Williams Co-lead UCB Biosciences

Project Members

Andy Richardson || Zenetar
Abdul Kadir Member Industry
Aku Kallioniemi Member Aastat
Amit Jain Member GSK
Aung Htun FDA
Andy Iverson Member Medtronic
Arpitha Hanumanthaiah Member
Dave Iberson-Hurst Member Assero
Dragomir Draganov Member Roche
Erick Antezana Member Bayer
Gaspare Mellino Member Roche
Giuseppe Di Monaco Member UCB
Hanming Tu Member Frontagelab
Ilaria Maresi Member TheHyve
Iraj Mohebalian Member Bayer
Jeremy Teoh Member Industry
Johannes Ulander Member S-cubed
Katja Glass Member Industry
Kerstin Forsberg Member Astrazeneca
Kurt Dauth Member Boehringer-Ingelheim
Lilliam Rosario FDA Lutz Weber Member Ontochem
Mike Hamidi Member CDISC
Marc Andersen Member StatGroup
Mark A Musen Stanford University
Matthew Wiley FDA
Matthew Travell Member GSK
Naouel Karam Member Fraunhofer
Nicolas Dupuis Member Sanofi
Nolan Nichols Member Gene
Nicholas Jeremy Nugent Industry
Raphaël Noirfalise Member JNJ
Rashed Hasan Member FDA
Siddharth Arthi Member Zifornd
Suhas Sanjee Member
Sujit Khune Member Novonordisk
Susheel Arkala Member MMSHoldings
Todor Primov Member
Tom Van der Spiegel Member JNJ
Vishnu Kollisetti Member PPDI

Project Updates

Provide project updates in this section.
Date: Description of Update

Objectives and Timelines

Objective Timeline
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

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Meeting Minutes

Archived Content