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Working Group Scope

Investigate how Linked Data, Semantic Standards, Property Graphs and Graph Analytics can support the clinical and non-clinical trial data life cycle from protocol to submission.

Projects Resources
Representing Clinical Program Design in RDF

2018: DIA Poster Presentation: The Clinical Development Design (CDD) Framework-Assisting and Improving Decision-Making for Product development

2017: Applied Clinical Trials Paper: Barriers and Solutions to Smart Clinical Program Designs

2016: White Paper: Introduction to the Clinical Development Design (CDD) Framework

2016: CSS Hirschfeld Clinical Trial Design Process. An Introduction

2015: Three Ws of Ontology

2015: Drafting the Information Model

CDISC Protocol Representation Model in RDF

2015: Draft version of model

SPIRIT Statement Website


Useful ContentResources
Study Design Questions
  1. Are the BRIDG extensions for the PRM included in the newer versions of the BRIDG Model?
    1. Yes, and more concepts
  2. EPOCH vs Period - A treatment EPOCH can include multiple periods - can this be handled with visit (StudyEventDef) Types (eg Washout, Baseline, etc)
  3. Alignment between PHUSE and CDISC
  4. Does/Should the RDF version include concepts of changes and roles?
  5. Need a selection of schedule of events to model
  6. What is the alignment of the odm:MetadataVersion to the sdm:Protocol - different versions of the schedule of assessments?
  7. What about modelling the actual text of the protocol?
Missing Elements in the Study Design Model

Each activity as defined by the SDM may have some associated sub-activities; as an example the Activity of measuring a blood chemistry value could have the associated sub-activities

* Subject at site
* Blood draw taken from Subject
* Date and time of Sample taken
* Blood sample labelled with a unique reference id
* Blood sample sent to lab
* Lab technician records comments on state of sample
* Blood sample analysed (multiple subsequent activities lie here)
* Result logged to Lab Information System
* Result shared or entered into CRF
* Result value checked against defined validation rule
* Comment entered on clinical significance of lab result 
* ....

Each of these sub-activities could enter in a study workflow system, and be useful for trial scheduling, etc.

Representation:

The representation of Roles in ODM is not expansive enough for a full workflow. BPMN heavily uses swimlanes for representation of workflows, but there is no way to catch the full gamut of requirements using the current SDM. Roles may apply to Organisms (such as Site Staff), but can also apply to non-Organisms (such as a machine). Indication of a Role of MRI Machine would provide valuable insight for study site selection or protocol planning; as an example say the executable SoA is entered into a workflow system, but the site knows that an important piece of equipment is out of service for scheduled maintenance at some point, then recruitment could be influenced by following the workflow back to the start.



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