Monitoring & Reporting Requirements Questions/Answers
Investigators assess and report unanticipated problems occurring during a research study in accordance with applicable federal, state, and local regulations and the Organization's policies and procedures.
Answers
What are examples of events/issues that you report to the IRB?
The Investigator Quick Guide [PDF] is a one-page handout listing categories of events/issues to report including unanticipated problems, violations, unresolved subject complaints, federal agency inspections, data and safety reports, subject incarceration, etc.
What unanticipated problems or adverse events are investigators required to promptly report to the IRB?
The UK IRB Policy on Unanticipated Problems and Safety Reporting [PDF] requires investigators to promptly report Unanticipated Problems Involving Risks to Subjects or Others (UPIRSO) as well as other safety-related information important to human subject protection or study integrity. See the policy for reporting timeframe requirements for each category. The Prompt/NonPrompt Reporting [PDF] guide was developed to help research teams understand the differences between an internal prompt event and an internal non-prompt event, based on the first three prompt reporting criteria in the UK UP Policy.
