- -Friday, 11 November 2011 19:00
Consistent with FDA and OHRP guidance on Adverse Event Reporting to IRBs, effective November 11, 2011, Sterling IRB no longer requires the submission of IND safety reports (“External Adverse Events”) unless the event(s) may represent an unanticipated problem involving risks to subjects or others. Please see Chapter 7 – Reportable Events of the Sterling IRB Investigator Handbook for additional information regarding Safety Reporting guidelines.
All IND safety reports that may represent an unanticipated problem involving risks to subjects or others must be submitted to Sterling IRB within 10 business days of receipt using the IND Safety Report Cover Page. This form is available on the Sterling IRB website and may be accessed here.