IMP-TRACK – Bristol Trials Centre

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 VICI, GAP 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