Drug accountability is important to gathering quality data as well as for insuring patient safety. The problems associated with it remain key issues for clinical trial management in 2021.
Using an IRT (IVR/IWR) system to manage the distribution and assignment of an investigational product (IP) is now a well-established practice. Most IRTs include some method of managing and documenting the return and destruction of IP consistent with federal guidelines (ICH E6) that require Sponsors to account for the disposition of unused investigational product.
But IRTs differ in the functionality they offer to assist in accountability. This can put the burden on the Sponsor/CRO to develop a comprehensive checklist of requirements for accountability.
A smart IRT system can prevent user data entry errors and can be used for documentation of the disposition of the unused study drug
- Only drugs that were dispensed to a subject will have the option to be recorded in the returned accountability. For example, if a bottle contains 30 tablets, the system should be smart enough to only accept the entries that add up to 30. (28 used, 1 not used, and 1 missing.)
- The system will also be smart enough to not accept a returned date that was prior to the date the drug was dispensed.
- Once the tablet accountability is completed, typically the site monitor is expected to verify the entry made by the pharmacist.
- After the verification step has been completed, then the site may have the option of destroying drug at site or may be required to return it back to the depot for destruction. The IRT can be programmed for either or both options.
- Drug that was never dispensed to a subject can have a different status (available, damaged, or expired) and may or may not need to be verified by the site monitor.
- The IRT can be customized as required for each study.
IRT Checklist — Options to meet your study needs
- Accountability for both numbered Clinical Trial Material (CTM) or Bulk Drug
- 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.).
- Allow the warehouse/depot to confirm receipt and record status once destruction occurs.
- Allow sites to record destruction by unit or by shipment of IP destroyed at the site, with a date.
- Add free text comments/explanations at the level of individual IP units.
- Allow authorized users to conduct independent verification of the return data, or to correct the data as required.
The IRT system can save time
- Easily spot units that have not been returned but should have been, as well as units remaining to be verified.
- Quickly create return shipments on demand to specify the precise units to be included in each shipment (For example, the kit numbers are already pre-loaded on to the return window, you can check them off individually as needed, or select “all” to include them all into the same return shipment in one keystroke.
- Designate units as ‘not returned’ and provide a reason and date.
- Select by site and country the specific warehouse/depot to which each return shipment will be sent.
- Record shipping tracking information in the system.
- Record shipment anomalies – e.g., IP missing from the shipment.
- Send automated notifications to all designated study team personnel for each aspect of drug accountability activity.
Veracity Logic includes all these functions in an easy-to-read and use dashboard. Users can also download this information into a spreadsheet for further analysis or reporting.
Your IRT (IVR/IWR) system should include features that simplify processes and help avoid potential problems. If that’s not the case, contact us to see how we can support your next clinical trial.