(e.g., those that occurred the Sponsor, but no later than with participants that were the time of continuing review enrolled outside of the local during the approval period for site of the IRB jurisdiction). which the event occurred. Sponsored required N/A Deadline is determined by reporting. sponsor Kevin L. Nellis, MS, CIP Original Issue Date: 03.16.2017 Revision Date: N/A Date Revision Required Responsible Staff Name and Title Reviewed & Approved Yes No 03.16.2017 X Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protections and Quality Improvement 03.30.2017 X -Updated IRB Kevin L. Nellis, MS, CIP, Executive Director, Human reporting Research Protections and Quality Improvement requirements for SAE.
(e.g., those that occurred with participants that were enrolled outside of the local site of the IRB jurisdiction). the Sponsor, but no later than the time of continuing review during the approval period for which the event occurred. Sponsored required reporting. N/A Deadline is determined by sponsor Kevin L. Nellis, MS, CIP Original Issue Date: 03.16.2017 Revision Date: N/A Date Reviewed & Approved Revision Required Responsible Staff Name and Title Yes No 03.16.2017 X Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protections and Quality Improvement 03.30.2017 X -Updated IRB reporting requirements for SAE. Kevin L. Nellis, MS, CIP, Executive Director, Human Research Protections and Quality Improvement
GuidanceReportableEvents03.30.2017_000.docx