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Adverse Event Definitions and Reporting

  • Adverse Event Reporting
  • Definitions of AEs, Grading and Attribution and available systems for categorization: The Common Toxicity Criteria (CTC) Grading Scale v3.0
  • AIDS
    SAEs defined in Section 16.1
  • Documentation: RU AE Log or tracking form, SAE and UAE reporting forms
  • Reporting requirements:
Type of AEReport to:Timeframe for reportingWeb Reference
All AEs RU IRB Annually Section 16 and Section 12
Unexpected AEs grade 2; Serious AEs RU IRB Within 2 working days* Section 16.1
Unexpected (grading is protocol specific) AND/OR Serious AEs: read carefully as this is vague FDA, Sponsor As soon as possible (phone, fax writing), but within 7 days, full written report within additional 8 calendar days* http://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=312.32
Section 312.23

Any IND Safety Reports received from the Sponsor will be filed with the IRB promptly.