Difference between revisions of "Study Data Validation and Submission Conformance"

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|Giuseppe Di Monaco || Participant || UCB  
|Giuseppe Di Monaco || Participant || UCB  
|Katja Glass || Participant || Bayer

Revision as of 04:13, 27 February 2019

Project Overview

This project builds on the successful completion of the "Clinical Trials Data as RDF" project where four SDTM domains (DM, VS, EX, TS) were modeled in RDF, and the ontologies used to create RDF instance data.

Existing domains will be broadened to include non-clinical concepts, thus extending the impact of the project further along the data lifecycle. A minimum of two additional domains will be added, starting with AE (and non-clinical AE equivalent observations).

The project team will focus on the following topics:

  • Non-clinical - expertise added to the team, including an additional project co-lead.
  • Ontology - focussing on ontology developed and concepts
  • Data Derivation - converting data to match the ontology
  • Define XML - creation of SDTM Define for the domains in the study
  • Linked Data Education - Creation of a GitHub repository for learning resources, including the StudyURI subteam that will promote URI's as unique identifier for clinical trials.

The value proposition for the project includes:

  • Separation of the results (instance) data from the Standards data and metadata, resulting 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 standards data to the results data. Costs for recoding between CDISC versions will be drastically reduced.
  • Generation of highly-compliant, high-quality SDTM domains for study submission using a much more automated process than is currently available. Costs for data review, validation and re-work will be greatly reduced.
  • Support for nonclinical data (SEND)
  • Participants with expertise in RDF creation and querying, including ontologies and related tools.
  • CDISC SDTM/SEND terminology and domain knowledge, including DEFINE.
  • Example Data: CDISCPILOT01 for SDTM. Non-clinical data will located or created in order to support the project.
  • Project team members actively working on CTDasRDF will roll-over into the new project, ensuring adequate staffing and consistency of approach.

Project Leads

Tim Williams Co-lead UCB Biosciences tim.williams@phuse.eu
Armando Oliva Co-lead Semantica LLC aoliva@semanticallc.com
Drashtti Vasant C0-lead Bayer Business Services GmbH drashtti.vasant@bayer.com

Project Members

Name Role Organisation
Iraj Mohebalian Participant Bayer
Giuseppe Di Monaco Participant UCB
Katja Glass Participant Bayer

Project Updates

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

Objectives and Timelines

Objective Timeline
Project Initiation February 2019
Supporting Ontologies PhUSE CSS 2020
Instance Data, Define XML PhUSE CSS 2020
Communications (Presentations) PhUSE CSS 2020 and PhUSE EU 2019
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.

Meeting Minutes

Archived Content