It is the submitter's responsibility to ensure that any restricted Patient Identifying Information (PII) contained within a document is removed, deleted or fully redacted before that document is transferred to eTMF. It is also the submitter's responsibility to ensure that documents containing information that may result in unblinding the treatment randomization should be filed in the appropriate restricted section. This information system supports research projects sponsored by both private sector clients and the U.S. Government. Access to this system is limited to authorized users, and any user activity on this system may be monitored or recorded and is subject to audit. Anyone using this system expressly consents to such monitoring and is advised that if such monitoring reveals unauthorized or improper use, system personnel may provide evidence to assist in investigative activities, including providing evidence of possible criminal activity to law enforcement professionals.