Representing CDISC Protocol Representation Model in RDF
Representing CDISC Protocol Representation Model (PRM) in RDF
|Geoff Low||Industry Co-Lead||Medidata||glow at mdsol.com|
|Ron Katriel||Medidata||rkatriel at mdsol.com|
|Kerstin Forsberg||AstraZeneca||kerstin.l.forsberg at astrazeneca.com|
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
There are four major components of the PRM v1.0—that is, four major areas of a protocol that the elements are related to:
- 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.
- Eligibility - Elements related to eligibility criteria such as minimum age, maximum age, and subject ethnicity.
- Study Design Part 1 - Elements related to a study’s experimental design, such as Arms and Epochs.
- 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:
- Study Design Part 2
- Study Design Part 1
- Clinical Trial/Study Registry
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:
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)
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
- CDISC - Protocol Design
- Study/Trial Design Model and SDM XML
- HL7 Study Design Structured Document Standard (SDSD)
- SPIRIT Statement website
|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|