Sponsors and study investigators are required to report information that may represent unanticipated problems involving risks to participants and others to Goodwyn Institutional Review Board within 10 working days.

An unanticipated problem is one that is (1) unforseen and (2) indicates that participants or others are at increased risk of harm. Unanticipated problems involving increased risk might be indicated in the following:

•IND safety letter
•breach of confidentiality
•summary of interim analyses and DSMB reports
•new publications and labeling changes
•subject compaints that indicate unexpected risks
•audit reports
•reported or observed non-compliance
•other events that may represent unanticipated problems