Reporting Requirements and Timeframes

Death Of An NU/NU Affiliate* Participant That Is

  • Unanticipated
  • Related
  • Reporting Timeframe: Within 24 hours of knowledge or notification

Reportable New Information

  • Information pertaining to an NU/NU affiliate* that fits into any of the categories listed on the Reportable New Information page.
  • Reporting Timeframe: Within 5 business days of knowledge or notification 
 *NU subject includes subjects enrolled at NU’s affiliate sites (RIC, NMH, NMG) or sites for which NU has agreed to serve as the IRB of Record through a signed IRB Authorization Agreement (IAA).
Note:  Information that does not fit into one of the categories listed on the Reportable New Information Page does not need to be reported to the IRB.