Clinical Trials Data as RDF

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Project Overview

Why are we doing this project?

A recent survey showed 26% pf CDER SDTM applications had at least one error. This doesn't even cover data quality or correctness. The current data models are clearly not sufficient. We will look at the data models for these standards so we can move into the future.

High level project goals

Future proof data models that will lead to highly compliant SDTM domains and Integrated DEFINE - having the data and meta data available directly within the data to create the DEFINE based on a query. So create validated SDTM domains by query, and rule sets.


We will model to the data and not to the standards. We are not taking SDTM and modelling to SDTM, we are taking the data that makes up the SDTM domains and modelling those appropriately. We will then use some of the existing rule sets and terminology files like SDTM terminologies, RDF plus others to bring that validated SDTM domain data out as a deliverable from the query, using things like SPARQL/SPIN rules. We'll be using data that is within existing SDTM domains, convert it to linked data then roundtrip it back out to an SDTM domain and do a comparison, in the hope it will be as good, if not better.

Project Leads

Name Role Organization E-mail
Tim Williams Project Lead UCB
Armando Oliva Project Lead Industry

Project Participants

Name Role Organisation E-Mail
Daniel Choi Participant FDA
Amit Jain Participant ICON
Andrew Miskell Participant Lilly
Anna Wong Participant Meddra
Carla Santillan Participant Chiltern
Dave Iberson-Hurst Participant Assero
Eric McGill Participant Accenture
Frank Menius Participant Chiltern
Frederik Malfait Participant IMOS
Guy Garrett Participant Achieve Intelligence
Hanming Tu Participant Accenture
Hans Peter-Schreiter Participant Entimo
Hans Van-Tricht Participant GSK
Ippei Akiya Participant DataDriven
Jeno Pizarro Participant Industry
Johannes Ulander Participant S-Cubed
Mike Hamidi Participant PRA Health Sciences
Kannan Nagureddi Participant Amgen
Kerstin Forsberg Participant AstraZeneca
Kathleen Ferguson Participant UCB
Nicolas Dupuis Participant Novartis
Magnus Wallberg Participant Who-UMC
Marc Andersen Participant Stat Group
Parag Shiralkar Participant Independent
Phil Ashworth Participant Industry
Scott Bahlavooni Participant d-Wise
Simon Lundberg Participant AstraZeneca
Suhas Sanjee Participant Merck
Sujit Khune Participant Novonordisk
Susheel Arkala Participant MMS Holdings
Vishnu Kollisetti Participant PPDI
Michael Stackhouse Participant Chiltern
Jinyi Wang Participant Worldwide Clinical Trials

Project Updates

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

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Objective 1 Timeline 1
Objective 2 Timeline 2
Objective 3 Timeline 3

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