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 [email protected]

 

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

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Print Advertisement Template (pdf)

English Radio Advertisement Template (Word doc)

Spanish Radio Advertisement Template (Word doc)

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Sterling Sample Submission Letter Requesting IRB Review (Word doc)

Sterling Investigator and Site Questionnaire Form (Word doc)

Sterling IRB Justification Form (Word doc)

Sterling Financial Disclosure Form (Word doc)

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Links for Sterling Application:

Click here to print the application

Click here enter information directly into the application from your computer

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TACT Data Entry System (Internet Case Report Form)