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 2/17/2004(pdf)
Outline of changes made to Protocol 5/30/2003(pdf)
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 firstname.lastname@example.org
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 Form 1572: local IRB version (doc)
FDA Form 1572: Sterling/Central IRB version (doc)
TACT Recruitment Tools and Advertising
TACT Data Entry System (Internet Case Report Form)