Clinical Research Resources
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 AE | Report to: | Timeframe for reporting | Web 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.