This document outlines the key components and functions of a clinical trial management system, including modules for data exchange, core data management, investigational product management, randomization, supply management, and tracking subjects and products throughout the clinical trial process from manufacturing to distribution to patient use. It presents a conceptual reference architecture showing how different sites, vendors, and user groups would interact with the system's various modules and applications.
Conceptual Framework for a Clinical Supply Chain solution stack
1. External Associations
In house Associations
Data Exchange Services
Core Data
EDI Java Web Services ETL Archival Media FTP
Randomization Supply
Subject
Identification
Master Data
Management
(MDM)Investigational
Product
DemandLabel
Modular Functions and Direct Applications
Sourcing Manufacture Distribution
Real World
Tracking
Packaging,
Labeling
Forecasting
Reconciliation
and Return
Conceptual Reference Architecture (A state view to be built towards)
Which
sites,
Vendors
Controls,
On
Demand
Batch,
Lot, Time
Point,
Visit
Shelf Life
Reissue
Tracking
Shipment
Supplies,
blister or
vial
Reports
Destructi
on,
Notificatio
n
Interactive
Randomization
(IVRS, IWRS)
Clinical Trial
Management
(CTMS)
Commercial
Manufacturing
(MRP)
Facility / Depot
Investigational Product Inventory Management User Interface
Real world outlet
- Internet portal
SSH or DMZ
enveloped
Intranet or VPN
accessed portal
User Groups
Regulatory
Affairs
Quality
Assurance
Clinical
Inventory
Management
Manufacturing Clinical Ops
Study Managers,
CRAs, Medical
Advisors
Partners
(CSOs, CROs)
CMOs
Depots
Country Units,
International RA
