Unanticipated problem definition:  An unanticipated problem (UP) is an event or discovery of new information that is (1) unanticipated¹, (2) involves new or increased risk of harm² to research participants or others and (3) is related to the research³.

¹Unexpected/unanticipated in terms of severity, nature or frequency than previously known, when compared to the Protocol, Study Product Information, ICD and the population being studied.
²New or increased risk of harm to participants or others suggests that the research places the participants or others at a greater risk of harm [including physical, psychological, economic or social] than previously known, when compared to the Protocol, Study Product Information, ICD and the population being studied.  New or increased risk may be further defined as one that may require action (e.g. modifying the ICD).
³Related to the research reasonably thought to be caused by the procedures involved in the research.

Reporting of these events should occur regardless of whether the event/information is discovered during or after study completion, after participant withdrawal or completion of the research. 

Submission of Safety Reports that do not meet RCRC reporting criteria, but reporting is required by Sponsor or Site policy. 

RCRC understands that most Sponsors have a policy which requires submission of all safety reports to the IRB. If you must submit to satisfy Sponsor or site policy, please send the report along with a cover letter/email stating, "The submitted report does not meet RCRC reporting criteria; submitting to satisfy sponsor requirement".  RCRC staff will review the report to be sure that it does not meet RCRC reporting requirements and will acknowledge receipt and return the acknowledgment.