Making Changes to Enrollment
You may need to document changes in a patient's status in the MPS I Registry. This includes changing patient demographic information, transferring a patient to a new primary treating physician, withdrawing a patient from the MPS I Registry, as well documenting a patient's death.
Since physicians submit patient clinical information to the MPS I Registry, any patient requests for changes in his/her information should be made through you or your Study Coordinator by completing the appropriate data entry screens in EDCR or by contacting the MPS I Registry Staff for more information. This will assist in the routine maintenance that is required to keep the Registry database up to date.
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 MPS I Registry in writing of your patient's withdrawal of authorization by completing the appropriate data entry screens in EDCR.
If you withdraw a patient from the MPS I Registry, the patient's personal ID number, initials, and the physician link will be removed from the MPS I Registry database. Your patient's clinical data will remain in the database for use in aggregate data reports; however, this data will no longer be linked electronically with any identifying information. Also, if a patient withdraws from the MPS I Registry, new clinical data pertaining to the patient will not be included in the next data report. In other words, no new information pertaining to the patient will be entered into the database.