Intestinal Registry’s Scope

Mission
The mission of the ITR is to provide data on the outcomes of intestine transplantation to the international intestine transplant community in order to support their efforts and improve outcomes as well as inform policy development.

Background
The Intestinal Transplant Registry (ITR) is currently managed by the Intestinal Transplant Association (ITA) under the direction of Matthew Everly. Analyses are directed by the Research Committee of the Association.

The Registry has collected data on the world-wide outcomes of intestine transplantation since 1985. Data are provided every two years by participating centres. It is compiled, verified, analyzed, and presented in aggregate form only at the Bi-Annual meeting of the ITA. Specific queries about outcomes are provided to participating centres upon request.

Data Collected
Currently, the Registry collects the following information:

• Donor information
• Recipient demographics, such as gender and age
• Pre-transplant diagnosis leading to transplant
• Pre-transplant status (the patient’s condition before transplant)
• Type of transplant (bowel; bowel & liver; or “cluster transplant”)
• Post-transplant status and complications
• Anti-rejection drugs taken by patients

Analyses

• Descriptive reports of donor and recipient profiles; and transplant outcomes
• Inferential Analyses to determine factors affecting outcomes by means of:
  1. Pre-transplant diagnosis leading to transplant
  2. Pre-transplant status (the patient’s condition before transplant)
     • Univariate analyses (data checking and validation)
     • predictive multinomial model building

Privacy and Confidentiality
Data are presented in aggregate form only, and international privacy and data security have been met ensure patient data and centre confidentiality.

To visit the Intestinal Transplant Registry website, please visit www.intestinaltransplant.org

It is highly advisable that the update be done electronically, through the Microsoft Access file sent to each centre. If this is not possible, we have set up an online form on this site that allows paper based centres to update without the need to physically mail the forms or fax them.

Please fill out the online form for each patient, AND attach the corresponding PDF* form for each patient for verification purposes.

• For patients Transplanted after May 31, 2007 - New Patient Forms (BETA)


• For patients Transplanted before May 31, 2007 - Patient Update Form (BETA)

In case of any doubts or inquiries regarding ITR patient forms please contact:

Max Marquez, MD
max.marquez@uhn.on.ca

Our Commitment to Privacy and Security

Data Use Policy
The Intestinal Transplant Association (herein “recipient”) collects and utilizes a limited patient data set from its participating centres (herein “sender”) as described in the Statement of Agreement.

Privacy Agreement

1. The sender agrees to be in compliance of the Health Insurance Portability and Accountability Act of 1996 (HIPPA) or other relevant national legal standards including but not limited to adequate institutional approval from the sender.


2. The recipient agrees that it shall not use or disclose Personal Health Information (PHI) or Limited Data Set (LDS) information except as permitted under this Statement of Agreement.


3. The recipient may use the LDS information received or created by it (a) to perform its obligation under this Agreement consistent with research connected with statistical determination of aggregate outcomes after Intestinal Transplantation as is the mission of the Recipient, and/or (b) to carry our its legal responsibilities if the disclosure is required by law, and/or (c) for data aggregation functions, as defined by HIPPA.


4. The recipient is sole entity that is permitted to use or receive the LDS.


5. The recipient provides assurance that:
   1. It shall not use or disclose PHI or LDS information except as permitted under this agreement.
   
   
   2. Appropriate procedural, physical, and electronic safeguards, sufficient to comply and exceed with the requirements of HIPPA, are currently in use in order to prevent any use or disclosure of LDS information other than as permitted or required by this agreement. See Annex A.
   
   
   3. Any information regarding unapproved use or disclosure of PHI or LDS that is neither permitted by this Agreement nor HIPPA shall immediately be reported to Covered Entity.
   
   
   4. PHI and LDS for all subjects will be held confidentially and used or further disclosed only as required by law or for the purpose for which it is disclosed.
   
   
   5. The recipient will use statistical methods to effectively de-identify individual subjects and participating centers. The statistical analyses will examine data in the aggregate form only. There is no conceivable risk that the information will allow identification of a specific study subject or centre.
   
   

Annex A
IRTA undertakes reasonable efforts to ensure that all personally identifiable information collected on our site remains secure. The database is within a Secure Server in a Private Network, under strict electronic security measures including: (a) mirrored drives; (b) daily backups; (c) firewall; (d) record level data made anonymous; (e) entire database encryption; (f) password protected server, directory and database file; (g) limited aggregated data set used for analysis in standalone computer. Physical security measures include, but are not limited to: (a) restricted access area with individually logged key entry; (b) locked file cabinets for physical records (if any).

Questions
Questions about the IRTA privacy policy should be addressed to the IRTA web site through the following link .