Managing Drug With IRT

Case Studies, IRT Essentials

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?

Here’s a quick checklist of things to consider:

  • Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include:
    • Site
    • Sequence number (blinded unit randomization)
    • Study-specific IP unit label – i.e., kit, bottle, vial, etc.
    • Drug/treatment type - ability to make available only to unblinded users
    • Shipment in which the unit was included
    • Batch or lot in which the unit was included
    • Subject to whom the unit was assigned
    • Activity/date at which the unit was assigned – including ability to assign at unscheduled visits. Disallow changing assignment dates.
    • Current unit status – e.g., options should include: assigned, available to be assigned, missing, in transit, unusable, damaged, mis-administered (and to whom/when), quarantined/subjected to temperature excursion
    • Drug accountability: e.g., unit returned, returned contents verified (tablets used, unused, missing), unit destroyed, designate inclusion in a return shipment
    • Unit status history – dates at which other statuses applied (e.g., previously quarantined for temperature excursion, now re-available)
    • Expiration date – editable and enforceable at the individual unit level
    • Ability to handle both individually numbered kits and ‘non-numbered’ bulk, ancillary, or supplemental materials
  • Easy access to batch/lot information:
    • Batch ID
    • Expiration date – editable and enforced by system
    • Region/countries to which batch/lot applies
    • Drug types included in batch/lot
    • Quantity in batch/lot
    • Ability to issue reminders when a batch/lot is close to expiration
  • Separate datasets for Planned and Manufactured drug units to reduce system overhead
  • Ability to load drug and batch information individually or to import en masse, within and across sites
  • Ability to review a shipment’s temp tale (shipment temperature tracking) information in the IRT, to flag shipments with Temperature Deviations/Excursions, and to flag shipments already reviewed
  • Ability to update kits marked as potential Temperature Deviation as Available (for assignment to subjects) or Damaged (which are automatically replaced)
  • Resupply: ability to resupply drug both automatically and manually, and be able to designate which sites will utilize predictive resupply algorithms
  • Ability to assign offset values (number of days) for not assigning, distributing, or including in inventory drug that is too close to expiration
  • Blinded and unblinded notifications relating to drug assignments and shipments

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