International Society for Heart and Lung Transplantation
Initial Application
For A
New ISHLT Registry
Instructions and Application Process Overview:
NOTE: Discussion with the R&DC Chair is strongly encouraged before completion and submission of
a new registry application.
1. This Initial Application must be completed in collaboration with the leadership of one of more
ISHLT Scientific Councils.
2. Once final and approved by the appropriate Scientific Council Operating Board(s), the
application should be submitted by the Council-designated Project Lead to the Registries and
Databases Committee (R&DC) Chair via the ISHLT office (amanda.rowe@ishlt.org)
3. The R&DC will perform a review of the application and will request additional information
from the applicant if needed.
4. The R&DC will submit the Initial Application with its review and recommendation to the
ISHLT Board of Directors (BoD) at its next meeting (usually held in January, April, and
October).
5. For applications of interest, the BoD will request that a Follow-up Application be submitted.
This document will assist in the securing of a cost estimate. Please do not submit the Followup Application until requested by the ISHLT R&DC to do so.
6. Once the Follow-up Application has been submitted, staff will work with the applicants, the
Finance Committee, and the R&DC to develop a preliminary cost estimate for the development
and operation of the proposed Registry.
7. The R&DC and BoD will evaluate the Follow-up Application in conjunction with the cost
estimate and will make a final decision regarding approval of the proposed Registry.
Completed applications should be submitted to Amanda.Rowe@ishlt.org.
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Initial Application for a New ISHLT Registry
Proposed Name of Registry:
Date of Submission:
Submitted by:
Project Lead Name (must be an ISHLT member):
Name of Sponsoring Council(s):
Date of Council Approval(s):
1. What are the Scientific Objectives of the proposed Registry?
2. What are the main scientific questions the Registry would be designed to answer?
3. Why it is a good time to start the Registry now?
4. Are similar data already being collected or available elsewhere?
5. What are the inclusion criteria for patient entry into the Registry?
6. What is the desired time of initial entry into database?
[ ] At time of transplant
[ ] At time of device implant
[ ] Other (please specify):
7. Are follow-up data to be collected?
[ ] Yes
[ ] No
8. If follow-up data are to be collected, please specify the timing:
[ ] Annually
[ ] Event initiated (please specify event(s) and frequency(ies):
[ ] Other (please specify):
9. What entities will data be collected from?
[ ] Individual centers
[ ] Collectives (regional/national data collection organizations)
[ ] Both
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10. Who will participation in the Registry be open to?
[ ] Limited number of institutions
[ ] All interested institutions
11. If open to only a limited number of institutions, how will those institutions be selected?
[ ] Invitation
[ ] First-come/First-served
12. What is the total anticipated number of institutions you expect to enroll in the first 5 years?
13. How many institutions (if any) have expressed an interest in participating in the Registry?
14. How many patient entries would be needed to have an 80% power to answer the key
scientific questions?
15. How many years do you anticipate data collection will be necessary in order to answer the
relevant scientific questions of the Registry?
[ ] 1-3
[ ] 4-6
[ ] >6
16. Please provide a justification for your answer to question 15:
17. Please indicate the relationship of this Registry to other ISHLT Registries:
[ ] Stand-alone
[ ] Integrated into the ISHLT Thoracic Transplant Registry (i.e. capture additional
information on patients already being entered in the Transplant Registry
[ ] Integrated into IMACS Registry (i.e. capture additional information on patients
already being entered in the IMACS Registry)
[ ] Other (please specify):
18. Do you believe there is a potential to secure funding for this Registry from sources other
than ISHLT?
[
[
[
[
] No
] Participating institutions
] Industry
] Other (please specify):
19. Please provide specifics regarding funding sources indicated in question 18:
20. Please provide a rough estimate of the number of data fields the Registry would collect:
At time of registration and initial entry:
At time of follow-up:
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