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The drug reconciliation process
The sponsor is accountable for all drug units shipped or dispensed in a study. At the end a study, the field monitor and site user must confirm:
- The drug units shipped to sites during the study.
- The whereabouts of each drug unit.
- The drug units that are left over at the end of the study (which must be destroyed).
In IRT, the results of this process are recorded in these steps:
- The site user enters drug reconciliation details.
- The field monitor enters drug reconciliation details.
You can over-label the expiration date for unused drug supply during this process. For more information, see Over-labeling of unused drug units.
