The Treatment and Unblinding Report shows the history of all patients who had their treatment or package assignment unblinded in the system. The actual unblinded results do not show up on the report. Unblinding actions taken by Global Patient Safety will be recorded on this report but do not result in the patient being discontinued from the study unless reason entered was Emergency Treatment or Other.

1. Unblinding Personnel – The date and name of the person who unblinded a patient's treatment or package assignment is recorded in this section. Site personnel who unblind a patient will typically have a User ID that is a 7-digit number (IVRS) or an email address (IWRS). Alphanumeric User IDs are usually Global Patient Safety personnel or possibly medical personnel.



2. Unblinding Reason – This is the descriptive information as to why the unblinding occurred. Additional documentation for the unblinding is only required when the unblinding is done through e-CTS and the reason entered was "Other".



3. Package – This field will show the package number that was unblinded. An unblinding record with a blank package indicates personnel only requested the subject's treatment assignment to be unblinded.