Multi-Institutional Research Application (MIRA)

The MIRA is a follow-up to the TRIA and is required whether you are participating in a multicenter clinical trial or just obtaining drug, device, equipment, donation/loan of equipment, pilot money, or other third party resources, etc.  UofL must have a contract completed with the respective company.  If you did not contact Office of Industry Contracts (OIC, 852-8359) via the TRIA, please do so immediately.  The protocol budget must be completed before submitting the MIRA.  The MIRA and IRB submission can be done at the same time.  To make applications to the respective regulatory offices, OIC and HSPPO (IRB), please contact OIC first to get the OIC number as it is used as a part of the IRB submission process, then contact the IRB for a protocol number, if you did not do so previously for the TRIA.  Having the OIC number and the IRB protocol number  makes tracking of your study easier.

Information on the development, Q&A, and the MIRA form can be found at:

http://louisville.edu/research/offices/industry-contracts/common/mira-multi-institutional-research-application-information.html .  If you have any questions, or need assistance please contact the OIC at 852-8359.

If your division/department/research group does not have a regulatory coordinator to assist you in the completion of the MIRA, you can obtain assistance at:

Clinical and Translational Sciences Institute: PCIR core, http://louisville.edu/ctsi

Office of Clinical Research Services and Support (OCRSS, https://louisville.edu/research/ocrss/about)

Guidance for IRB submissions can be found in the SOP templates:  http://louisville.edu/research/clinicaltrials/investigators/Guidelines%20for%20SOP.pdf/view