If you’re assigned to review a reportable new information report (RNI), here are a couple of reminders and resources that may be helpful:
- Please look over the entire CLARA form and any additional documents submitted with it. If you’d like more information about the event before the meeting, you can either contact the study team directly, or contact the IRB office, either directly or through the chair, to have the office contact the study team on your behalf. The office sees these reports before the reviewers do, and we try to get all the information you’ll need for the meeting before sending the report to the full board. However, we’ve noticed our reviewers pick up on aspects we in the office hadn’t considered, so we’re happy to help do more digging in time for the meeting.
- RNI reports require the IRB to determine whether the reported event meets the definition of an unanticipated problem involving risk to subjects or others (UPIRTSO) or represents a level of noncompliance (minor, serious, or continuing). More information about UPIRTSOs is available in IRB Policy 10.2. Noncompliance is discussed in IRB Policy 12.6. Note that the IRB can determine that a particular event is neither a UPIRTSO nor an incidence of noncompliance. Whatever the IRB determines should be adequately supported by notes entered into CLARA and the meeting discussion, as recorded in the study minutes.