Documentation


Appendices

Appendix A - Adverse Event Definitions


Appendix B - IRB Guidelines


Appendix C - Patient Information Sheets and Consent Templates


Appendix D - Site Regulation Agreements


Appendix E - Financial Disclosure and Conflict of Interest


Appendix F - Quality of Life Questionnaires

EQ-5D-3L

English Adult Quality of Life Questionnaire

Spanish Adult Quality of Life Questionnaire

Appendix G - Trail Making Test (Part B)


Appendix H - Kansas City Cardiomyopathy Questionnaire (KCCG)


Appendix I - Stroke Scales


Appendix J - Data Access Request

One of Intermacs/Pedimacs deliverables to the MCSD community is to provide statistical analyses and/or registry data to established recipients including the Federal partners (FDA, CMS and NHLBI), and collaborating investigators. Intermacs makes data and analytical resources available for research purposes through a process overseen by the Data Access, Analysis, and Publications Committee (DAAP).  This committee, chaired by Dr. Frank Pagani,  reviews all research proposals and is now meeting bi-quarterly.

There are two analysis options for a researcher interested in requesting registry-wide data:



Please be sure to  review our Existing Research and Statistical Summaries to avoid the submission of redundant requests.


Confidentiality and Privacy Policy
Intermacs is committed to maintaining the confidentiality and privacy of its membership. We do not sell or give out our membership data or contact information for our PI's and Coordinators. Any requests to obtain information from our membership require an interested party to submit a proposal to our Data Access, Analysis and Publications Committee for approval and pay any associated costs of having Intermacs directly collect information from our membership. Please contact Grant Studdard by email at grantstuddard@uabmc.edu or by phone at (205) 996-7761 for more information.

Appendix K - Device Brand List


Appendix L - Roster and Contact Information


Appendix M - Intermacs Users' Guide


Appendix N - Pedimacs Users' Guide

Pedimacs only. Click here for Pedimacs appendices.

Appendix O - Profiles of Advanced Heart Failure


Appendix P - Intermacs Data Collection Forms


Appendix Q - Pedimacs Data Collection Forms

Pedimacs only. Click here for Pedimacs appendices.

Appendix R - Clinical Center Responsibilities for Medical Device Reporting