IMP-TRACK

Efficient management of Clinical Trials of Investigational Medicinal Products (CTIMPs) requires systems to track the supply and accountability of study drug throughout the lifecycle of a trial. With NIHR CTU support funding Bristol Trials Centre has developed an IMP management system, IMP-Track, to fulfil this purpose. IMP-Track is available to CTUs and research groups and can be customised to suit a wide range of trial designs.

Features

  • Web-based application
  • Set-up is configurable independently by CTU users
  • Accommodates a range of trial designs e.g. 2+ group parallel, factorial and cross-over trials
  • Single and multi-centre trials
  • Role and site-restricted permissions
  • Secure server
  • Custom modifications on request

Stock Control

  • Ordering stock
  • Logging dispatch of stock orders e.g. from the manufacturing pharmacy
  • Logging receipt of stock orders e.g at site pharmacies
  • Cancel orders
  • Monitoring stock levels

Randomisation

  • In-built randomisation system
  • API – integrates with external randomisation or other systems (on request)

Drug Pack Accountability

  • Allocating drug packs to participants, inc. replacements for lost drug packs
  • Recording dispensing of drug packs
  • Participant prescription history
  • Recording drug pack returns
  • Recording drug pack destruction
  • Logging lost drug packs
  • Quarantining drug packs
  • Audit trail

Masked RCTs

  • Masked and unmasked user permissions
  • Unmasking of participant allocations

Other Features

  • Configure automated notifications e.g. of low stock or when drug packs are allocated
  • Cancel or undo actions e.g. cancel drug pack allocation or undo drug pack return if performed in error

CTIMPs utilising the IMP-Track management system are VICIGAP and Prompt2

IMP-TRACK Frequently Asked Questions

IMP-TRACK User Manual V10

Contact Us

If you are interested in using IMP-Track for management of IMP for your trial, please contact us on ctimp-manager@bristol.ac.uk or phone 0117 3423151

IMP-Track V2.0 Bristol Trials Centre University of Bristol, Level 7, Bristol Royal Infirmary, Upper Maudlin Street, Bristol, BS2 8HW Copyright © 2018 University of Bristol