Study Team Changes


Exiting Study Team Member

Prior to departure from a study, the exiting study team member should complete the following:

  • Outstanding data entry and/or data queries
  • Incomplete source documentation
  • Notification to the sponsor of the study team changes
  • Notification to the active subjects of the study team changes if the research team contact information will change for the subjects.  Letters or other materials that will be distributed to all subjects must have IRB approval prior to sending.
  • Provide a list of study-specific contacts (e.g., sponsor, monitor, OCR analyst)
  • Provide a list of outstanding issues

Incoming Study Team Member

Prior to starting the research, the incoming study team member should complete the following:

  • All required training/certification items mentioned in Chapter 2, Emory Training Requirements, of this Guidebook.
  • Notification to the sponsor of the study team changes

Change in Principal Investigator

If there is a change in PI, the following documents need to be revised and completed;

  • Seek approval from the sponsor for the PI change
  • Seek IRB approval via eIRB Amendment for the new PI. Consider revising the protocol and informed consent form, as appropriate.  Also consider notifying current subjects; correspondence sent to all subjects must be approved by the IRB.
  • Update the Form FDA 1572 (drug studies) or the Investigator Agreement (device studies)
  • Update the DOA log
  • Ensure that the new PI has completed the Emory required training and study-specific training

Documentation of Study Handover

The exiting and incoming study team member should document the study handover in a note to file or other documentation for the regulatory binder.  The note should contain some of the items above and the date of the handover.  The incoming study team member should obtain documented study-specific training and any required approvals prior to being added to the delegation of authority log.