The Patient Status Report is the most detailed report for every patient in the system.

1. Treatment Group Description – This column will default to a value of "Blinded" unless the study is open-label where the patient's actual treatment group name will be displayed.



2. Package Information – The package information will show the package number that was dispensed to the patient. If the date is different than the Patient Visit Date this could indicate special package maintenance was required. The dispense date is part of the e-CTS audit trail and cannot be updated.



3. Patient Visit and Status Information – This information reflects the date the site called into the system to process the patient's visit. The date should match the visit date in the data collection database. It also shows the current status of the patient at the last completed visit. To ensure the Site Enrollment Report and data transferred to the unconfirmed fields in IMPACT is accurate the data should be reconciled against the data collection database. The Patient Visit Date is part of the e-CTS audit trail and cannot be updated.



4. Visit Incomplete – The *!* in this column indicates where visit processing has not been completed. The system will not allow for the next visit to be processed until all previous visit activities are complete. Monitoring the completion of the visit will help avoid future site confusion when processing the subject's next visit.



5. Package Not Confirmed – The *!* in this column identifies any packages that was not confirmed in the system. This field needs to be monitored daily to ensure sites are confirming the packages before dispensing the IP to patient. Failure of the sites to confirm packages have resulted in incorrect IP assignment and subsequent patient safety risks. The system will not allow for the next visit to be processed until all packages are confirmed.