StudyBuilder Documentation Portal

# Conceptual Architecture

This section describe the conceptual architecture for StudyBuilder and Clinical-MDR with upstream and downstream systems.

Conceptual architecture for the clinical-MDR and the StudyBuilder

  • StudyBuilder Documentation Online documentation for the StudyBuilder solution including introduction, user guides, system documentation and data model documentation.
  • StudyBuilder App Vutify based Web application with the UI for creating the study definition specification.
  • Protocol Metadata add-in Microsoft Word add-in tool holding the Protocol Template and import features of the structured study specification metadata that relates to the protocol content.
  • Up-stream integrations Integrations to up-stream clinical systems like CTMS, Trial Supplies, EDC, Study Registries, etc.
  • Down-stream integrations Integrations to down-stream clinical data systems for SDTM, ADaM, analysis and reporting.
  • Explore data FAIR based study search and explore tool utilising the StudyBuilder metadata with reference to systems holding study data.
  • StudyBuilder API and Standards Library API Python based web application based on FAST API framework supporting all CRUD actions to the database, access control, versioning, workflows and data integrity rules.
  • Integration Service Integration to UNIX based Statistical Computing Environment (SCE) with SAS and R.
  • Clinical MDR Neo4j linked graph database and data model supporting the library standards, study definitions including fine granularity of versioning, audit trail, workflows and access control.
  • Standards Management Integrated into the StudyBuilder App as the Library module managing concepts, dictionaries, code lists, syntax templates, project and TA standards.

← System Component Architecture →