Participation Process

The Gaucher Registry Protocol, the Patient Authorization, and relevant supporting information should be submitted to an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for review and approval at the discretion of the participating physician. Since no experimental procedures are included in the protocol, approval of the Patient Authorization may be all that is required by the committee chairperson.

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

Upon your physician enrollment in the Gaucher Registry program and initiation, you will submit to the Gaucher 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 Gaucher Registry as defined by the Gaucher Registry Protocol.

Members of Genzyme Corporation's Gaucher 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 Gaucher Registry. They will not, however, have access to any identifying patient information.

The Gaucher 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 information from the aggregate database, data reports, and publications.