Hospital for Special Surgery ¤ Institutional Review Board
EXTERNAL SAFETY REPORT SUBMISSION COVER SHEET
Submit an original and 1 copy of the entire submission packet (inc. supporting documentation)
Date
HSS IRB#:
Protocol Title:
Principal Investigator:
Sponsor:
Sponsor Protocol#:
IND/IDE # (if applicable):
Safety Reports regarding events at sites other than HSS must be reported to the HSS IRB as follows:
Drug: Adverse event is (1) SERIOUS and UNEXPECTED and ASSOCIATED WITH THE USE of the
experimental study drug, or (2) an unanticipated problem involving risks to subjects or others.
Device: Adverse event is unanticipated.
**** To facilitate submission, you may list up to 10 separate EXTERNAL reports on this form. ****
Please attach corresponding reports to this form.
Date of Report
Adverse Event
Unique Identifier
or Manufacturer’s
Report #
Are you requesting
a consent revision
as result of this
report?
[Must complete]
Yes*
No
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10
*If you are requesting an informed consent form revision, you must specify language.
Please provide a copy of the consent form with changes indicated.
__________________________________________________________________________________
PI Signature
Date
IRB Reviewer Use Only
IRB Requested Modifications (if any):
No Requested changes as a result of this submission
Jacques Yadeau, MD, PhD – ViceChairman, IRB
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