An overview of the project background, goals, and approach. Includes links to the project white paper and other related publications.
Details of project structure and methods including project data files, scripts, coding conventions, and data modeling decisions.
Github repository structure.
Data files, including source study files and project .TTL files generated from TopBraid.
Ontology details.
The approach to data conversion differs between MedDRA and the SDTM XPT files. Please see their respective sections for details. For methods using SAS, please see the "Hands-on" guides in the next section.
Step-by-step guides to working with the data.
A step by step guide to install required software, create data, load data and browse data.
A step by step guide to hands-on how to create triples based on an ontology using the Trial Summary as example.
A guide hot to use the SMS visualization app available in the repository.
A guide to understand the Adverse Event Ontology, how to investigate this and see data realated to one Adverse Event triplefied.
These instructions show how to setup an Apache Jena Fuseki triple store to locally upload triples and perform queries.