Welcome to the Trial to Assess Chelation Therapy (TACT) Portal

TACT Institutional Review Board Materials

Sterling IRB will serve as the IRB for TACT clinical sites that do not have an affiliation with a local IRB.
For further information regarding Sterling IRB, please visit their website at www.sterlingirb.com.

Instructions for Applying to Sterling/central IRB (pdf)

Protocol

If you are a new clinical site you ONLY need to submit the most recent version of the protocol to your IRB.

TACT Protocol 5/5/2006 (pdf)

TACT Protocol 5/30/2003 (pdf)

TACT Protocol 2/17/2004 (pdf)

Outline of changes made to Protocol

Outline of changes made to Protocol 2/17/2004(pdf)

Outline of changes made to Protocol 5/30/2003(pdf)

Informed Consent Forms(ICF):

Informed Consent Form 5/5/2006 - English(doc)

The Informed Consent Form is also available in Spanish, Korean, and Russian. Contact the Clinical Coordinating Center, (305) 674-2703 or tactnih@msmc.com

Investigator’s Brochure (IB):

TACT Investigator’s Brochure 2/24/2006 (pdf)

TACT Investigator’s Brochure 3/14/2005 (pdf)

TACT Investigator’s Brochure 2/19/2003 (pdf)

FDA 1572:

Submit a COPY to your IRB and MAIL ORIGINAL to:
Research Assistant
Mount Sinai Medical Center
TACT, Clinical Coordinating Center
Department of Cardiovascular Research
4300 Alton Road, Butler Building
Miami Beach, FL 33140

FDA Form 1572: local IRB version (doc)

FDA Form 1572: Sterling/Central IRB version (doc)

TACT Advertisement Templates:

Click on the link below for a listing of all available advertising templates.

TACT Recruitment Tools and Advertising

TACT Data Entry System (Internet Case Report Form)