The study teams may encounter situations where the intended change is one-time, impacts only one or two subjects, and is not a study-wide change. For these situations, the ORIO reporting process can be utilized to obtain IRB approval. As applicable and feasible, the sponsors and/or coordinating centers should be contacted for their concurrence. The study team should carefully evaluate whether the intended change is a one-time or a permanent study-wide change before using this ORIO process.
Example(s) of scenarios where this process may be permitted:
Example(s) of scenarios where this process will NOT be accepted:
When submitting the ORIO:
Once submitted, the ORIO will be reviewed by IRBMED staff to ensure that the proposed changes are in compliance with this guidance. The submission will then be assigned for either expedited (if the changes meet the regulatory definition of “minor”) or full board review (if the changes are substantial and/or may impact subject safety).
NOTE: If IRBMED notes that a study team is submitting frequent one-time/urgent ORIOs for an individual IRB application, IRBMED may require a protocol amendment to permanently address inclusion/exclusion criteria or protocol procedures that are not addressing current/recurrent circumstances.