Dental Research Informatics-Requesting AxiUm Records

 Dental Research Informatics-Requesting AxiUm Records

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Step one:

Prepare protocol. Investigator writes protocol and determines what type of data set is required.  Note: AxiUm data is available beginning January 2011.

Types of Data Sets:

De-identifiable: Data does not require a patient’s consent. For more information and a description of de-identified data visit this website: http://irb.ufl.edu/irb01/hipaa/hipaa-identifiers.html

Identifiable: Prior consent from the patient is required when the data set calls for specific identifiers.  May include variables such as: names, chart number, birthdate, etc.

The IRB may issue a waiver of informed consent for certain types of studies.  Contact the IRB for more information.

Step two:

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.

Step three:

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.

 

Step four:

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.

 

Step five:

After receiving the Honest Broker’s approval the data is provided to the investigator.