The Department of Veterans Affairs has released a NEW Version of Handbook 1058.01 (Research Compliance Reporting Requirements). The Office of Research Oversight (ORO) is requiring that all local Standard Operating Procedures be revised in order to incorporate these changes no later than October 1, 2015.
Research Service will be revising SOP 151-10 (Requirements for Reportable Research Events) as a result of the modification of this Handbook.
In the interim, effective immediately:
Local serious adverse events (SAEs) that are BOTH unanticipated AND related (caused by or probably caused by) the research are required to be reported, in writing, to the IRB within 5 business days.