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Lead Clinical Research Associate

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

Legally Authorized Representative (LAR)

  1. Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. (FDA)
  2. A person authorized either by statute or by court appointment to make legal decisions on behalf of another person. In human subject research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

Limited Data Sets

Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual's relatives, employers, or household members. Limited data sets may be used or disclosed for purposes of research with a data use agreement as described by the HIPAA Privacy Rule at 45 CFR 164. For more information, including the list of identifiers that must be removed from health information in a limited data set, see HIPAA and Human Subjects Research.

Local Event / UM Event

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.