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

TACT Regulatory Requirements-Canada

Investigator Profile (SIS Form) (Word doc) (insert “TACT IIS 9-19-03.doc”)

Memorandum of Agreement MUST be typed and signed. Mail two (2) original copies to the CCC.

Memorandum of Agreement Amendment (pdf)

FDA Form 1572 (Word doc, IRB Services/central IRB version)

FDA Form 1572 (Word doc, local IRB version)

Financial Disclosure Form (pdf)

Conflict of Interest Form (pdf)

Protocol Signature Page for Protocol dated May 5, 2006 (pdf)

OmniComm Site Information Sheet (Word doc)

Site Responsibility and Signature Log (Word doc)

Electronic Signature Authorization Form (pdf)

FWA Application Form (Word doc)

Professional History Form (pdf)

Central IRB Registration Form (Word doc)

Qualified Investigator Undertaking Form (Word doc)

Laboratory Normals (pdf)

Sub-Investigator Profile (SIS Form) (Word doc)

When your site obtains IRB approval, begin screening your patient charts for potentially eligible patients by using the following Screening Log. Once you have started screening patients FAX your log to the CCC at (305) 674-3970

Screening Log (pdf)

TACT Data Entry System (Internet Case Report Form)