What is a Clinical IRT?

The Basics: IRT stands for Interactive Response Technology; it uses the web or phone to allow users to interact with a system. A Clinical IRT is a web-based tool for managing subjects and inventory during a clinical trial/study.

It allows the clinical research site users (including Primary Investigators, Sub-Investigators, and Study Coordinators) to:

  • add subjects to a study (screening)
  • randomize subject to a treatment group
  • record subsequent drug/kit assignments
  • record screen failure before or withdrawal after randomization, and
  • record subsequent activities for those subjects
  • receive shipments
  • indicate when shipments have been received and make the study medication available for assignment to subjects
  • track drug accountability and reconciliation

Activities that can be recorded are configurable, based on the needs of your study.

It allows users at the Warehouse and/or Regional Depots supporting the study to:

  • receive shipment requests for each clinical site (or for the regional depots)
  • indicate when a shipment request has been sent to the sites

Clinical IRT also allows the project team at the Sponsor and/or CRO to:

  • review the progress of the study (number of subjects at each status during the study)
  • update certain configurable settings (such as limits on the number of subject allowed to be screened or randomized during the study, with a country, or at each site, again, depending on the needs of the study)
  • manage sites and users (add, activate, update, and deactivate) as needed throughout the study

Your team may include Clinical Project Managers, Clinical Research Associates (Site Monitors), Clinical Trial Assistants, Medical Monitors, Data Managers, Biostatisticians, and other as needed.

A Clinical IRT is a key tool for quickly and easily managing your clinical trial. We’ve listed some of the primary functions you should expect to see in any IRT system. Other functions are available based on your project’s needs.

 

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