iSTAR – integrated System for Trial Allocation and Randomisation

integrated System for Trial Allocation and Randomisation (iSTAR) is a mobile-friendly web-based platform, developed by UBC PRE-EMPT, used to streamline the processes of double-blind randomised controlled trials (RCT). iSTAR is designed to be flexible so that it can be customised as per specification.

iSTAR offers the following features:

Screening & Randomisation

  • Customised screening questions
  • Randomisation (random blocks and stratification)
  • Participant Discontinuation – Stopping drug dispensing for participant

Drug Dispensing

  • Multiple dispensing
  • Information about bottles inventory per site
  • Bottle/kit/lot number customisation

Bottle Management

  • Setting bottle expiry date
  • Inactivating bottles due to damage or loss, etc.
  • Transferring bottles between sites

Bottle Shipment

  • Creating, editing, and voiding shipment orders
  • Shipment order summary report

Reporting Tool

  • Screening, Randomisation, and Drug Dispensing reports
  • Record filtering and sorting
  • Report exporting in Excel

For Offline Procedures

  • Manual entry of offline randomisation
  • Contingency bottles dispensing

Email Notification

  • Confirmation of randomisation and drug dispensing
  • Notification of low inventory of study drug

Input Validation

  • Real time validation
  • Build-in algorithms for data validation
  • Build-in algorithms for check of invalid data

User Access

  • User groups assignment
  • Separation of roles
  • Access authentication and authorization

Configuration

  • Email notification list
  • Settings for randomisation/dispensing
  • Settings for clinical trial/study

Error Handling

  • Log of errors
  • Log of security threats
  • Log of locations and timestamps

Mobile View – Eligibility Evaluation

Mobile View – Drug Dispensing

Randomisation Summary

Shipment Order