Modifications for study changes and reports

Investigators are responsible for reporting any changes to the protocol to the IRB before the changes are instituted. These can include adding or removing study personnel, adding or revising study advertisements, updating FDA form 1572s, sponsor protocol amendments and revisions to investigator brochures, modifications to the consent and assent documents, new investigator financial or other personal interests, etc.

  • Changes which are not substantive and do not affect the risk to benefit ratio for subjects may qualify for expedited review.
  • Changes that are substantive and affect the risk to benefit ratio for subjects must be reviewed by the full board.

Click here to access your study electronically in eIRB

  • Your 1st step is to open your study in eIRB:
    Click on "New Modification" for proposed changes, amendments, and study modifications. 
    Click on "New Reportable Event" for unanticipated problems, adverse events, protocol deviations, DSMB reports, and acknowledgement requests.

Appendices for applications are located here