Who is responsible for each step in the kit reconciliation process?

The workflow is flexible so that you can opt to use the parts that are required for the protocol and any relevant SOPs. All of these steps are available in Oracle Clinical One Platform when you require kit reconciliation, but they're not required.

1. Reconcile and verify kits:
   1. A subject returns a kit to the site.
   2. A site user changes the status of the kit to Returned to Site and indicates the number of returned and missing units.
   3. A CRA verifies the kit.
2. Destroy kits:
   1. A CRA marks kits that are ready for destruction, including the returned kits that the CRA verified as well as damaged, expired, and undispensed kits.
   2. The next step depends on the location of the drug destruction facility:
      • If a site is drug destruction capable, the site user destroys the kits and changes the status of the kits to Destroyed according to the protocol and relevant SOPs.
      • If a site can't destroy drugs on site, either the CRA or someone at the site sends the kits that are ready for destruction to a depot that is a drug destruction facility, where they are destroyed according to the protocol and relevant SOPs. The receiving depot can be either the depot that shipped the product to the site or a tertiary depot that provides destruction capabilities. If required, the clinical supply manager can change the status of the kits to Destroyed, or sponsors can opt to skip this final step.