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:
- 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
Got questions not covered in this list?
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