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

Individual Components of revised Study Manual

Table of Contents

Study Manual Table of Contents (pdf)

Study Overview

Study Overview (pdf)

Consent Form, Agent Designation Form, and Confidential Patient Information Form

Agent Designation Form (pdf)

Confidential Patient Information (pdf)

Tools for Screening, Visits, and Recruitment/Retention

Screening Log (pdf)

Screening Worksheet, Revised June 22, 2006 (pdf)

Patient Visit Record (pdf)

Additional Vitamin Accountability Record (pdf)

Infusion Visit Worksheet for visits requiring labs (pdf)

Infusion Visit Worksheet for visits not requiring labs (pdf)

Recommended responses to symptoms during chelation infusion (pdf)

TACT Visit Projector Instructions (pdf)

TACT Intent to treat (pdf)

Recruitment and retention information (pdf)

Conquering retention of TACT patients (pdf)

Patient Recruitment Resources (pdf)

Economics and Quality of Life (EQOL)

EQOL Overview (pdf)

EQOL Data Flowchart (pdf)

EQOL Baseline Questionnaire Guidelines (pdf)

Standard Interviewing Guidelines (pdf)

Basic Annotated Quality of Life Questionnaire (pdf)

Adverse Events and Serious Adverse Events

Definitions of AE and SAE, Completion of iCRF AE page, and Adverse Event Flow chart (pdf)

Unmasking (unblinding) of treatment group (pdf)

Clinical Events Classification

Clinical Event Committee requirements for classification of endpoints (pdf)

iCRF Instructions

iCRF User Manual and TACT iCRF instructions (pdf)

Replace current pages with the following revised pages dated August 3, 2006

Screening iCRF page 3 (pdf)

Instructions page 4 (pdf)

Concomitant medications page 24 (pdf)

Adverse event page 26 (pdf)

Adverse event page 30 (pdf)

Pharmacy Information

Information on ordering, delivery, storage, preparation and disposal of study drugs (pdf)

Sample shipping/packing slip (pdf)

Illustration of chelation materials (pdf)

Illustration of vitamin packaging (pdf)

Lab Information

General Information and instructions (pdf)

Handling information - Specimen processing (pdf)

Shipping information - Labeling specimens (pdf)

Guidelines for abnormal lab results (pdf)

Sample requisition form (pdf)

Post-MI Guidelines

American College of Cardiology recommendations for post-MI therapy (pdf)

HIPAA and Protection of Human Subjects

HIPAA guidelines and references (pdf)

Information for completing protection of human research subjects training (pdf)

Where to Find Help

Helpline Information, Study Directory, and Website Information (pdf)

TACT Data Entry System (Internet Case Report Form)