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Roadmap: Drug accountability

Step #

Action

What happens?

1

The site user and field monitor reconcile the inventory

The site user and field monitor review the drug supply records for the study, discuss any discrepancies, and then reconcile the discrepancies.

This process is tracked by IRT.

2

Excess supplies are destroyed

Leftover drugs are shipped to the drug destruction facility (DDF) after reconciliation.

Upon receipt, the DDF user must check the shipment to confirm the security of the packaging and the contents.

3

The destruction of supplies is confirmed

After the drug units are destroyed, the DDF user notifies the sponsor. The result is recorded in IRT.

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