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.

Philosophy

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 Tim.Williams@ucb.com
Armando Oliva Project Lead Industry AOlivamd@gmail.com

Project Participants

Name Role Organisation E-Mail
Daniel Choi Participant FDA Daniel.Choi@fda.hhs.gov
Amit Jain Participant ICON Amit.Jain@iconplc.com
Andrew Miskell Participant Lilly Andrew.Miskell@lilly.com
Anna Wong Participant Meddra Anna.Zhao-Wong@meddra.org
Carla Santillan Participant Chiltern carla.santillan@chiltern.com
Dave Iberson-Hurst Participant Assero Dave.Iberson-Hurst@assero.co.uk
Drashtti Vasant Participant Bayer drashtti.vasant@bayer.com
Eric McGill Participant Accenture Eric.J.McGill@accenture.com
Eric Antezana Participant Bayer erick.antezana@bayer.com
Frank Menius Participant Chiltern Frank.Menius@chiltern.com
Frederik Malfait Participant IMOS Frederik.Malfait@imos-consulting.com
Guy Garrett Participant Achieve Intelligence guy.garrett@achieveintelligence.com
Hanming Tu Participant Accenture hanming.tu@gmail.com
Hans Van-Tricht Participant GSK Hans.x.van-Tricht@gsk.com
Imran Syed Participant Bayer imran.syed1@bayer.com
Ippei Akiya Participant DataDriven Ippei.Aki@datadriven.jp
Jeno Pizarro Participant Industry jenopizzaro@gmail.com
Johannes Ulander Participant S-Cubed JU@s-cubed.dk
Mike Hamidi Participant PRA Health Sciences hamidimike@prahs.com
Kannan Nagureddi Participant Amgen Knagured@amgen.com
Kerstin Forsberg Participant AstraZeneca Kerstin.L.Forsberg@astrazeneca.com
Kathleen Ferguson Participant UCB kathleen.ferguson@ucb.com
Nicolas Dupuis Participant Novartis nicolas.dupuis@novartis.com
Magnus Wallberg Participant Who-UMC Magnus.Wallberg@who-umc.org
Marc Andersen Participant Stat Group MJA@Statgroup.dk
Parag Shiralkar Participant Independent pcshiralkar@gmail.com
Phil Ashworth Participant Industry pashworth6@gmail.com
Scott Bahlavooni Participant d-Wise Scott.Bahlavooni@d-wise.com
Simon Lundberg Participant AstraZeneca Simon.A.Lundberg@astrazeneca.com
Suhas Sanjee Participant Merck Suhas_Sanjee@merck.com
Sujit Khune Participant Novonordisk Sjtk@Novonordisk.com
Susheel Arkala Participant MMS Holdings Sarkala@mmsholdings.com
Vishnu Kollisetti Participant PPDI Vishnu.Kollisetti@ppdi.com
Michael Stackhouse Participant Chiltern Michael.Stackhouse@Chiltern.com
Jinyi Wang Participant Worldwide Clinical Trials jwang43@ncsu.edu

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