Drug accountability and the problems associated with it remain key issues for clinical trial management as we move into 2018.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of investigational product (IP) is now a well established practice. Most IRTs these days also include some method of managing and documenting the return and destruction of IP consistent with federal guidelines which require Sponsors to account for all of their trial’s unused drug.
But IRTs differ in the functionality they offer with regard to accountability. This puts the burden on Sponsor/CRO outsourcers to develop a comprehensive checklist of requirements for accountability.
The following is a quick list of features which should be included when vetting an IRT system. All of these capabilities should be available and easily configurable, with no custom coding required:
- The ability to select between two levels of accountability – ie., at the kit (vial, bottle, etc.) level or at the level of the contents (tablet count, liquid weight remaining, etc.).
- Edit checks which challenge the logic of conditional options – that is, drug that has been assigned to a subject, drug that is available at the site to be assigned, or IP that is damaged can be returned, whereas temporarily quarantined or missing IP cannot.
- The ability to specify date returned, and categories of count – for example, in the case of tablets, the number used vs. the number missing. Edit checks should confirm the logic of the total count.
- The ability for authorized users to conduct independent verification of the return data, or to correct the data as required.
- The system should prevent inclusion of unverified returns in a shipment request.
- The ability to create return shipments on demand to specify the precise units to be included in each shipment.
- The ability to easily spot at a glance units which have not been returned but should have been, and units remaining to be verified.
- The ability to designate units as ‘not returned’ and provide a reason and date.
- The ability to select by site and country the specific warehouse/depot to which each return shipment will be sent.
- The ability to record shipping tracking information in the system.
- The ability to designate by site whether destruction of IP will occur at the site or the warehouse/depot.
- The ability for warehouse/depot to confirm receipt and record status vis a vis destruction.
- The system should allow recording of shipment anomalies – e.g., IP missing from the shipment.
- The ability for sites to record destruction by unit or by shipment of IP destroyed at the site, with date.
- The ability to add free text comments/explanations at the level of individual IP units.
- The system should provide automated notifications to all designated study team personnel for each aspect of drug accountability activity.
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