SPARC

Study of Perfusion and Anatomy’s Role in CAD

Divisions of Nuclear Medicine/PET

Brigham and Women’s Hospital

75 Francis Street

Boston, MA 02115

Telephone: (617) 732-6291

Fax: (617) 582-6056

www.sparctrial.org

 

Monday, April 24, 2006

 

Dear SPARC Investigators,

 

In order to insure that all SPARC sites receive IRB approval, we have had to amended the SPARC protocol. The requested minor administrative change to the protocol includes adding a new SPARC Imaging Repository section. This administrative protocol change has resulted in a protocol amendment (Amendment 2, dated 20 APRIL 2006).   

 

ATTACHMENT

A PDF copy of the SPARC Protocol Amendment 2, dated 20 APRIL 2006

Please contact Jeselle Gierbolini directly for a copy of the amendment protocol.

 

ACTION ITEMS:

 

FOR SITES WITH IRB APPROVAL

1.    Due to the fact that the protocol change is administrative, study start-up and subject enrollment will not be contingent on approval of the amendment.

2.    REVIEW the protocol change and submit to your local IRB/EC for administrative review and approval.

3.    Principal Investigators need to sign and date Amendment 2 Protocol signature page. 

4.    SUBMIT the IRB approval letter to SPARC Project Manager.

 

FOR SITES WITHOUT IRB APPROVAL

1.    REVIEW the protocol change and submit to your local IRB/EC for initial review and approval.

2.    Principal Investigators need to sign and date Protocol signature page.  Send signed protocol signature pages to address listed below.

 

A copy of the amended protocol has been submitted to Western Institution Review Board on behalf of the sites using a central IRB.

 

 

Study of Myocardial Perfusion and Coronary Anatomy Imaging Roles in CAD