💊 Pharma & Life Sciences · C4 Architecture · Pro
Clinical Trial Management Architecture
The systems that run a clinical trial: trial management, electronic data capture, randomisation, drug supply and safety reporting.
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Drawing diagram…
What this diagram shows
- Sites enter patient data in the EDC system
- Randomisation and drug supply (IRT) assign treatment kits
- Serious adverse events flow to the safety database
Prompt used
Clinical trial architecture: the sponsor's clinical trial management system (CTMS) tracks sites and milestones; site staff enter patient visit data in the electronic data capture (EDC) system; an interactive response technology (IRT) system randomises patients and manages investigational drug supply; ePRO apps collect patient-reported outcomes; serious adverse events go to the safety database; data managers clean data and export CDISC datasets for statistical analysis.
Mermaid code
C4Container
title Clinical Trial Systems
Person(site, "Site Investigator", "Enrols and treats patients")
Person(patient, "Trial Patient", "Reports outcomes")
Person(cra, "Clinical Monitor", "Oversees sites")
System_Boundary(trial, "Trial Platform") {
Container(ctms, "CTMS", "Web", "Sites, milestones, monitoring")
Container(edc, "EDC", "Web", "Case report forms")
Container(irt, "IRT", "Web", "Randomisation and drug supply")
Container(epro, "ePRO App", "Mobile", "Patient diaries")
Container(safety, "Safety Database", "Web", "Adverse events")
Container(dm, "Data Management", "SAS", "Cleaning and CDISC exports")
}
System_Ext(depot, "Drug Depot", "Ships kits to sites")
Rel(site, edc, "Enters visit data")
Rel(site, irt, "Randomises patient")
Rel(irt, depot, "Resupply orders")
Rel(patient, epro, "Uses")
Rel(epro, edc, "Syncs")
Rel(edc, safety, "Serious adverse events")
Rel(cra, ctms, "Uses")
Rel(ctms, edc, "Monitors data")
Rel(edc, dm, "Exports")Related templates
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