Making Changes to Enrollment

Changes in a patient's status should be documented in the Registry database. This includes changes in patient demographic information, transfer of a patient to a new primary treating physician, the withdrawl of a patient from the Registry, and a patient's death.

Since physicians submit patient clinical information to the Pompe Registry, changes in patient’s information should be made through you or your Study Coordinator by completing the appropriate data entry screens in the EDCR or by contacting the Pompe Registry Staff for more information.

Patient Withdrawal from the Registry

Patients have the right to withdraw their authorization at any time. Requests to withdraw authorization must be made in writing to you, the physician. You must then notify the Registry in writing of your patient's withdrawal of authorization by completing the appropriate data entry screens in the EDCR.

If you withdraw a patient from the Registry, the patient's personal ID number, initials, and the physician link will be removed from the Registry database. Your patient's clinical data will remain in the database for use in aggregate data reports, including reports to regulatory authorities; however, this data will no longer be linked electronically with any identifying information. If a patient withdraws from the Registry, no new information pertaining to the patient can be entered into the database.