1. Change Log
  2. Releases in 2018
  3. Oracle Clinical One Platform 1.1 (March 2018)
  4. What's new?
  5. Drug accountability and reconciliation

Drug accountability and reconciliation

Great news for clinical supply managers! You can now manage the return or destruction of any unused product from within Oracle Clinical One Platform.
  • Clinical supply managers: The new drug accountability features allow you to demonstrate that the study drug was dispensed and administered according to the protocol.
  • Clinical supply managers: The new drug accountability features allow you to demonstrate that the study drug was dispensed and administered according to the protocol.
  • CRAs: You can now verify site returns and confirm that each site followed appropriate procedures for product destruction. In addition, you can approve either destruction or return of the drug, thus ensuring that sponsor and regulatory requirements for product handling are met.

Who is responsible for each step of kit reconciliation?

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.

New kit status: Returned to Site

When a subject returns a kit to the site, site users can now change the status of the kit to Returned to Site when they reconcile the kit. CRAs can filter for kits with this status when they do source data verification (SDV) of kits during their site visits.

The Pending Destruction status (renamed from Processed for Destruction) and Destroyed status aren't new but are now used for kit reconciliation.

Any other related changes?

There's a new report named Kit Reconciliation. For details, see the changes to reports.

Parent topic: What's new?