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Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)
A HIPAA-specific term, denoting a dataset that contains PHI with only indirect HIPAA identifiers. Specifically, the following types of HIPAA identifiers may be included:
See Research A-Z webpage Limited Data Sets for guidance on the requirements for using or disclosing an LDS.
An event which occurs in a study under the supervision of the UM IRBMED and whose principal investigator is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UMHHC, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the adverse event. If interventions take place at several different UM locations, please specify at which location the event occurred.
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