💊 Pharma & Life Sciences · Sequence
Clinical Trial Randomisation Sequence
How a site enrols a patient into a clinical trial: eligibility, consent, randomisation through the IRT and drug kit assignment.
Drawing diagram…
What this diagram shows
- Consent is recorded before any trial procedure
- The IRT assigns the arm and kit without revealing it to the site
- Kit shipments are triggered when site stock runs low
Prompt used
Clinical trial enrolment sequence: the site coordinator screens a patient against eligibility criteria in the EDC, records electronic informed consent, then calls the interactive response technology (IRT) to randomise. The IRT assigns a blinded treatment arm and a drug kit number from site inventory; if site stock falls below threshold it triggers a resupply from the depot. The visit is recorded in the EDC.
Mermaid code
sequenceDiagram
actor CRC as Site Coordinator
participant EDC as EDC System
participant ECON as eConsent
participant IRT as IRT / RTSM
participant DEP as Drug Depot
CRC->>EDC: Screen patient against criteria
EDC-->>CRC: Eligible
CRC->>ECON: Record informed consent
ECON-->>EDC: Consent signed
CRC->>IRT: Randomise subject
IRT->>IRT: Assign blinded arm
IRT-->>CRC: Kit number 0457
IRT->>IRT: Check site stock
alt Stock below threshold
IRT->>DEP: Resupply order
end
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