Going Translational with Linked Data
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.
|Tim Williams||Co-lead||UCB Biosciencesfirstname.lastname@example.org|
|Armando Oliva||Co-lead||Semantica LLCemail@example.com|
|Drashtti Vasant||C0-lead||Bayer Business Services GmbHfirstname.lastname@example.org|
|Giuseppe Di Monaco||Participant||UCB|
Provide project updates in this section.
Date: Description of Update
Objectives and Timelines
|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|
This section can document project activities or serve as a jumping off point to other pages in the project.