|
|
|
|
Drug reallocation
Drugs are reallocated when drug units that have not been assigned by IRT are provided to the subject during a visit. During reallocation, you identify the drug units that were provided to the subject, and reallocate the drug units that should have been supplied to the subject.
Drugs must be reallocated when:
- The subject is given the wrong drug units.
- The subject is given drug units that were not first identified by IRT.
These changes often require acknowledgment. A subject affected by a request for acknowledgment is locked (
) until the request is reviewed and either approved or rejected.
Drugs can be reallocated in any visit that drugs are dispensed. Before starting the reallocation, make sure you have all of the documentation available (examples: logs of drugs received, visit notification emails). You must have the IDs for the specific drug units that were provided during the visit.
During drug reallocation, you do the following:
- Verify the subjects' identity against the basic demographic information gathered during screening.
- Identify the drug units IRT allocated, which should have been given to the subject.
- Identify the drug units given to the subject.
- Confirm whether the drug units allocated by IRT are still at the site.
- Provide a reason for the reallocation, which must include the current location of the drug units.
