Seven “everyday” benefits of using an IRT

IRT Essentials

Major players in clinical trials have acknowledged the important role of early-input data from Interactive Response Technology (IRT/IVR/IWR) for Risk-Based Monitoring (RBM) assessments. (See previous hot topics on the subject by selecting All Hot Topics from the Main Menu.) A few examples of the IRT data available to the Site Monitor or Clinical Research Associate (CRA) for RBM are:

  • Visit window violations
  • Drug shipment issues
  • Drug expiry problems
  • Temperature control problems

But in addition to these vital RBM considerations, decision makers tasked with selecting an IRT package should ensure that a robust range of “everyday” benefits are available to the CRAs in the normal course of their site monitoring activities. Examples from Veracity Logic’s VLIRT® system include:

  1. Email and on-screen alerts when activities are past due
  2. One-stop, at-a-glance table views providing the status of all Subjects, Activities, Shipments, Kits, and (blinded) Site Inventories
  3. Summary Roll-up Reports that pull together subject data and activities within and across subjects and sites
  4. A capacity for keeping up with any special authorizations required by protocol – for example, instances of unblinding, age range deviations, out-of-window deviations, etc.
  5. Site record of drug accountability at a kit or content level, including returns (and failure to return)
  6. Easy access to Help aids for Site Users. For example, obtaining a new password; reaching the Help Desk (by email or phone); reviewing User Manuals, Quick Reference Guides, and any project-specific instructions, and so on
  7. Easy access to Site, User, and Warehousing information and preferences

And more!

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