Participation Process

The Fabry Registry Protocol, the Patient Authorization, and relevant supporting information may be submitted to an Institutional Review Board or Independent Ethics Committee for review and approval at the discretion of the participating physician. Since no experimental procedures are included in the protocol, expedited review by the committee chairperson is often the only requirement necessary to approve the Patient Authorization.

Patients/parents must complete Patient Authorization before data are submitted to the Fabry Registry. A patient's completed authorization is necessary for participation in the Fabry Registry.

Upon your physician enrollment in the Fabry Registry program and initiation, you will submit to the Fabry Registry your patient's initials, date of birth (DOB), and gender along with specific clinical data as defined by the patient enrollment section of this site.

You will prescribe the frequency of your patient's follow-up visits as part of his/her regular treatment program. After these follow-up visits, you should provide updated clinical information to the Fabry Registry as defined by the Fabry Registry Protocol.

Members of Genzyme Corporation's Fabry Registry Team and designated computer support staff - as well as representatives from public health regulatory agencies (such as the Department of Health and Human Services or other authorized government agencies) - may review the information in the Fabry Registry. In addition physicians may review aggregate data in the Fabry Registry.

The Fabry Registry will provide you with a summary of your patient's clinical information (identified by patient ID number, initials, gender, and DOB) to assist in monitoring your patient's treatment program. You will also have access to the aggregate database, data reports, and publications.