Mission and History
Description of the Clinical Facilities and Center for Clinical and Translational Science
Administration
Advisory Committee on Clinical and Translational Science
Institutional Review Board
Research Groups (Laboratories)
Principal Investigators
Clinical Studies and Protocols
Clinical Research Seminar
The Rockefeller University Hospital Departments
Virtual Tour
Center for Clinical and Translational Science
Center for Clinical and Translational Science e-Newsletter
Understanding Clinical Research
Clinical Studies and Protocols
Virtual Tour
Directions to The Rockefeller University Hospital
Clinical Scholars Program
Tri-Institutional MD-Ph.D. Program
Ph.D. Program
Post-Doctoral Program
High School Students and Internships
Required Training for the Conduct of Human Research
Site Map
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Overview
Requirements
Application Procedures
Research Opportunities
Electronic Clinical Research Resources
Recent Clinical Scholars
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
http://clinfo.rockefeller.edu/irb/IRB_Procedures.pdf
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
http://clinfo.rockefeller.edu/irb/
IRB_Procedures.pdf
Section 16 and Section 12
Unexpected AEs grade 2; Serious AEs
RU IRB
Within 2 working days*
http://clinfo.rockefeller.edu/
irb/IRB_Procedures.pdf
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
http://www.ich.org/pdfifpma/e2a.pdf
Part B, no 1
Any IND Safety Reports received from the Sponsor will be filed with the IRB promptly.
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