Representing CDISC Protocol Representation Model in RDF

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Contents

Project Overview

Representing CDISC Protocol Representation Model (PRM) in RDF

Project Leads

Name Role Organization E-mail
Geoff Low Industry Co-Lead Medidata glow at mdsol.com

Project Participants

Name Organization E-mail
Ron Katriel Medidata rkatriel at mdsol.com
Kerstin Forsberg AstraZeneca kerstin.l.forsberg at astrazeneca.com

Project Rationale

This protocol aims to copy the work done in the first phase, insofar as we want to be able to represent the concepts of the CDISC Protocol Representation Model using RDF

Project Deliverables

There are four major components of the PRM v1.0—that is, four major areas of a protocol that the elements are related to:

  1. Clinical Trial/Study Registry - Elements related to the background information of a study, based on the requirements from WHO and Clintrials.gov. Examples of elements in this area include Study Type, Registration ID, Sponsors, and Date of First Enrollment.
  2. Eligibility - Elements related to eligibility criteria such as minimum age, maximum age, and subject ethnicity.
  3. Study Design Part 1 - Elements related to a study’s experimental design, such as Arms and Epochs.
  4. Study Design Part 2 - Elements related to a study’s Schedule of Events and Activities.

We also have the Trial Design Model to include.

The suggested order is:

  1. Study Design Part 2
  2. Eligibility
  3. Study Design Part 1
  4. Clinical Trial/Study Registry

Status

We have a draft version of the model (in alpha-status). The model is located in GitHub in the phuse-org organisation and can be found via this link:

Schedule of Activities Model and Example

We spent some time working on the Protocol Concepts with CDISC, but have since decided to take a hiatus into the new year where we will re-engage and work on the next phase.

What has been suggested for further investigation:

  • Alignment with the Transcelerate Common Protocol Template
  • Model other components of the Protocol, to include
    • Modelling Inclusion/Exclusion Criteria using the RDF and including in the model (there has been work done on this previously)
    • Modelling of Endpoints and their relationship to Activities
  • Work on using topic maps to represent a protocol (with the underlying model being in RDF)


Project Meetings

We meet bi-weekly. The Meetings will in the most be recorded, and shared below.

The meeting room is at http://mdsol.adobeconnect.com/cdash2rdf/ (you can dial in with your computer or get the TC details from Geoff

Project Related Documents

Project Pages

Meeting Materials

Date Presentations Meeting Minutes Meeting Recording
1 Nov 2013 File:StudyDesignWeek1.pdf PRM_Meeting_01Nov2013
8 Nov 2013 TBC PRM_Meeting_08Nov2013 Meeting Recording
15 Nov 2013 TBC PRM_Meeting_15Nov2013 Meeting Recording
22 Nov 2013 TBC PRM_Meeting_22Nov2013
07 Dec 2013 TBC PRM_Meeting_07Dec2013
03 Jan 2014 TBC PRM_Meeting_03Jan2014
31 Jan 2014 TBC PRM_Meeting_31Jan2014

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