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1 Prepare protocol. Investigator writes protocol and determines what type of data set is required.
Prior consent from the patient is required when the data set calls for specific identifiers. The IRB may issue a waiver of informed consent for certain types of studies. Contact the IRB for more information.
2 Submit protocol to the UF Institutional Review Board (IRB) for approval. Note: Regardless of the type of data (de-identifiable or identifiable), the investigator submits a protocol to UF IRB. The Dental Clinical Research Unit (DCRU) can provide assistance with preparing IRB documents.
3 Once IRB has approved, submit an IT Helpdesk ticket to obtain data from AxiUm. Reference in the request the IRB approval number. IT requires a copy of the IRB approval document before accessing data. A HelpDesk ticket is created with an identifying number for follow-up.
4 IT retrieves the data and is submitted to UFCD’s “Honest Broker (currently Gigi Lipori)”. The Honest Broker reviews the data set for IRB approval specifications.
5 After receiving the Honest Broker’s approval the data is provided to the investigator.