Going Translational with Linked Data

Project Overview

This project builds on previous successful modeling of the SDMT domains DM, VS, EX, TS, and AE and conversion instance data to Linked Data as Resource Description Framework (RDF). The original follow-on project was approved to extend the concept to additional domains. At the CSS 2019 conference, the team recognised that the project goals should change to focus on smaller, modular projects that can be released over time to demonstrate incremental value in a shorter time frame (instead of merely extending to additional SDTM domains). The proposed new focus increases cooperation with the Food and Drug Administration and the Maintenance and Support Services Organisation (MSSO, for MedDRA).

This new proposal includes (but is not limited to) the following sub-projects:

a) MedDRA as RDF Development and release of R and SAS scripts that convert MedDRA ASCII files to RDF. Due to licensing limitations, only the MedDRA RDF instance data that supports a subset of the test project (CDISCPILOT01) will be released online. The conversion scripts will be available publicly from a dedicated Github repository that will include documentation and usage instructions. The project team has the interest of and permission from the MSSO for this subject.

b) Automating Conformance Checks for DM and TS domains in SEND and SDTM The team will update existing SDTM ontology for the TS and DM domains to accommodate SEND. SPIN, SHEX, and SHACL will be evaluated for their potential to model conformance checks for both SEND and SDTM, working in cooperation with the Centre for Drug Evaluation and Research, with Dr. Lilliam Rosario as FDA sponsor. The project will evaluate the efficiency of replacing manual conformance checks using an automated Linked Data approach, with potential efficiencies for both FDA and industry.

c) Unique Identifiers for Pharma A sub-group was formed after the PHUSE EUConnect18 to further develop the concept of "Study URI" presented by Kersin Forsberg and Daniel Goude from AstraZeneca. The group will develop methods and guidance for unique, universal, persistent identifiers for the pharmaceutical industry based on the RDF URI concept. Work is already underway (https://github.com/phuse-org/LinkedDataEducation/blob/master/doc/URIsForPharma.md) and a poster is planned for EUConnect19.

d) Study Ontology & Data Conversion Work on Study ontology development may continue as time allows, with primary focus on deliverables for sub-projects a) , b) and c).

Project Leads

Tim Williams	Co-lead	UCB Biosciences	tim.williams@phuse.eu
Armando Oliva	Co-lead	Semantica LLC	aoliva@semanticallc.com

Project Members

Abdul Kadir	Member	Industry
Aku Kallioniemi	Member	Aastat
Amit Jain	Member	GSK
Andy Iverson	Member	Medtronic
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
Lutz Weber	Member	Ontochem
Mike Hamidi	Member	CDISC
Marc Andersen	Member	StatGroup
Matthew Travell	Member	GSK
Naouel Karam	Member	Fraunhofer
Nicolas Dupuis	Member	Sanofi
Nolan Nichols	Member	Gene
Raphaël Noirfalise	Member	JNJ
Rashedul Hasan	Member	FDA
Siddharth Arthi	Member	Zifornd
Suhas Sanjee	Member	Merck.com
Sujit Khune	Member	Novonordisk
Susheel Arkala	Member	MMSHoldings
Todor Primov	Member	Ontotext.com
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
Project Initiation/Restart	February 2019/July 2019
MedDRA as RDF	PhUSE CSS 2020
Automating Conformance Checks	PHUSE CSS 2020
Unique IDs for Pharma	PhUSE CSS 2020
Conclusion	PHUSE CSS 2020

Project Activities

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