1. Analysis Results & Metadata in RDF Modelling Analysis Results & Metadata to Support Clinical and Non- Clinical Applications Development of standard models and technical standards for the storage and usage of analysis results data and metadata, to support clinical and non-clinical applications. Project Leads: Marc Andersen, StatGroup ApS; Ian Fleming, d-Wise http://www.phusewiki.org/wiki/index.php?title=Analysis_Results_Model

2. SAS output from RDF cube Courtesy of Marcelina Hungria, Dicore Group

3. RDF data cube observation Courtesy of Tim Williams, UCB Video http://youtu.be/9BH_hXmXklU

4. RDF data cube vocabulary http://www.w3.org/TR/vocab-data-cube/

5. Technical Guidance

6. R package using RRDF for creating RDF data cubes Package name: RRDFQBCRND0 R package RDF Data Cube (qb) for Clinical Research and Development 0 Located at GitHub repository: https://github.com/MarcJAnderse n/rrdfqbcrnd0 Uses R-package RRDF to interface to Apache Jena. Main author Marc Andersen, StatGroup ApS. Initial code and concepts Tim Williams, UCB. Input for programming of tests provided by Ippei Akiya, Data Driven

7. Setting the scene The Major Impacts of CDISC on Clinical Data Lifecycle – Article by Chengxin Li and Nancy Bauer, October 2012 http://www.cdisc.org/ejournal http://www.cdisc.org/system/files/all/article/application/pdf/major_i mpacts_of_cdisc_on_clinical_data_lifecycle_li__bauer.pdf

8. Create results as RDF !? Linked data to support Clinical and Non-Clinical Reporting, Marc Andersen https://semstats2014.files.wordpress.com/2014/10/semstats2014_submission_5.pdf Presented at SemStats 2014 | Second International Workshop on Semantic Statistics, https://semstats2014.wordpress.com/https://semstats2014.wordpress.com/

9. Under development / almost there Import results to RDF data cube Validate cube using W3C Integrity Constraints Other types of validation Visualization of cube Presentation of cube as table Vocabulary for Analysis Results & Metadata for clinical and non-clinical applications

10. Benefits of representing Analysis Results & Metadata in RDF Traceability Common structure Provide context to results through metadata Provide new ways for analyzing, combining and visualizing data Metadata available from standard sources (e.g. CDISC standards in RDF) and other steps in the development process (e.g. from protocol)

11. Plan for deliverables in 2015 Assessment of using RDF data cube vocabulary for representing Analysis Results & Metadata Proof of concept including – Creation of an R package that creates RDF Data Cubes and associated documentation – Adaptation of a PhUSE Code Repository SAS program to use as input into the R package – Creation of a SAS program that queries the RDF Data Cube using SPARQL to reproduce the original table Technical specification of the cube model White Paper for considerations and benefits of modeling Analysis Results & Metadata in RDF