IRB Version Date: 2/2012
Saint Louis University
Institutional Review Board (IRB)
INSTRUCTIONS FOR COMPLETING THE SERIOUS ADVERSE EVENT (SAE)
Guidelines require study investigators to report any fatal or life-threatening event within 3
calendar days and any serious or unanticipated event within 7 calendar days.
NOTE: The SAE form is to be completed for events related (possible, probable or definite) to a particular
human research protocol approved by the SLU IRB. For questions on reporting SAEs to the IRB, please
refer to the Requirements for Reporting Events Relating to Subject Safety.
Step 1:
Download the SAE report form. Handwritten forms are not acceptable. Add the IRB# at the top right
corner. Fill in the date you are completing the report. Complete the contact and study title information.
Step 2:
Question #1 pertains to the type of SAE reporting information that is being submitted.
If you answer “yes” to questions 1a, 1b, or 1c, the IRB will require the investigator completing this form to
provide the details about the SAE. In addition to completing the table in Appendix A, question #2 will
need to be answered for each event being reported. The relevant information used to determine whether
an adverse event is related must be provided in a “MedWatch” type of format, discharge summary, ER
report, or clinical summary. For an example of the type of information in a MedWatch form, see the
following website: http://www.fda.gov/medwatch/getforms.htm
Check the box in 1c if the SAE is an Unanticipated Problem. An Unanticipated Problem (UP) is an
adverse event that is:
 Any unexpected serious adverse event or problem reasonably related to a SLU
protocol that was not previously identified in the informed consent document,
research protocol, or investigator’s brochure, AND
a. The event is not consistent with or exceeds the nature, severity or
frequency described in the protocol, consent form, or investigator’s
brochure,
OR
b. The event relates to the rights, safety, or welfare of the subjects .
Step 3:
Question #2 pertains to SAEs that occurred within our institution or where a SLU investigator is the head
or coordinator of a multicenter study and is responsible for reporting SAEs or if the event is an
Unanticipated Problem. Provide a) the event number from the table and b) a description of each event
and a description of medical actions taken and the findings. Please include the timeline of events,
whether the event occurred while the subject was actively receiving treatment, relevant medical history,
as well as any other contributing information to support the designated relationship (column H on table) of
the SAE. Attached documentation does not replace an answer to this question.
Step 4:
Questions 3 and 4 pertain to informed consent.
FDA does not require re-consenting of subjects who have completed their active participation in the
study, or from subjects who are still actively participating when the changes occur, if the changes will not
affect their participation. According to FDA regulations, 21CFR 50.25(b)(5): “Those subjects who are
presently enrolled and actively participating in the study should be informed of the change if it might relate
to the subject’s willingness to continue their participation.
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IRB Version Date: 2/2012
Step 5:
Questions 5 and 6 pertain to SAEs that occur at a Tenet or SSM property.
While the SLU IRB serves as the IRB of record for all research of SLU personnel at these locations, each
individual property provides administrative research oversight to that research. All SAEs that occur at
these locations must be reported for administrative oversight.
Appendix A
The following are instructions for completing the boxes in the table in Appendix A.
Note: The text boxes will expand as needed.
A)
B)
C)
D)
E)
F)
G)
H)
Please number the events in consecutive order (e.g., 1, 2, 3). The most recent events should be
placed last. When adding events to the table, highlight in yellow so that the IRB reviewer will
know which event(s) are new.
Follow-Up SAEs: If you are submitting a follow-up to a previously submitted SAE, insert a row
into the table directly below the original SAE that is being followed-up. To insert a row, place your
curser in the row of the original SAE. Then click on Table in the windows toolbar on the top of
your screen. Next, select “Insert” from the drop down menu, then select “Rows Below”. If the
original SAE is numbered 1, you should number the follow-up 1.1, 1.2, 1.3, and so on.
Enter the original date of occurrence of the SAE.
Check the appropriate site of occurrence, SLU or other institution.
Check the appropriate option of submission: initial or follow-up
Follow-up would only be marked if the original SAE had been previously submitted to the IRB
office for the same subject.
Fill in the unique subject ID number for each subject submitted.
List the code letter for the appropriate item(s).
H = Hospitalization
PH = Prolonged Hospitalization
PD = Resulted in permanent disability
DISC = Discontinuation of drug/device for medical reasons
DCA = Development of a congenital anomaly
BD = Development of a birth defect
CA = Cancer
A = Autopsy performed
LT= Life Threatening
D = Death
P = Pregnancy
SME = Other Important/Significant Medical Event (Examples of such events include
allergic bronchospasm requiring intensive treatment in an emergency room or at home,
blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the
development of drug dependency or drug abuse.)
Indicate “Other” and provide description for events that do not fall under one of the above
categories.
Indicate the “key words” of the SAE (pneumonia, renal failure, rash, etc.) There may be several
key words. List all that are applicable.
Choose option 1-4 to represent the relationship of causality of the SAE to the study (which may
include the study drug or ancillary drugs, study procedures, the use of placebo, or randomization
procedure). If sponsor reports do not use these designations of causality (for example, the
reports state “yes” or “no”), then state their designation.
 If (3) “probable” or (4) “definite” is chosen, or the investigator believes that there is a
“sufficient number of similar AE’s” of (1) “not likely” or (2) “possible” events to cause
concern, then a change-in-protocol form should be submitted within 3 weeks. The risk
section of the protocol (#11) and parts of the consent form, including the discussion of
risks (item #4), should be modified. The IRB may query the investigator to ascertain
further details of the SAE’s that would determine the necessity of protocol and consent
modifications.
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IRB Version Date: 2/2012
Include the number of previously submitted similar SAE’s (information from this cumulative table
including the current event being reported).
J) Indicate if this SAE is already mentioned as a possible side effect in the consent form.
K) Indicate whether the protocol and consent form need to be modified to include the new
information.
L) Indicate whether the SAE is also an Unanticipated Problem (UP).
IMPORTANT: Indicate which events are new by highlighting in yellow or by (lightly) shading the
applicable row(s). If the highlighting or shading is too dark, the text will be unreadable on copies made of
the report. Since the table is cumulative, only new events should be highlighted each time the SAE report
is submitted. Add boxes as needed by putting the cursor in the last box of the table and hitting the ‘tab’
key. This will add a new row to the table.
I)
Step 6:
The principal investigator should sign and date the SAE form.
Step 7:
Attach any supporting documentation for the SAEs. Please attach them in the order that the new
(highlighted) SAEs are listed in the table.
Step 8:
Attach any revised materials. Be sure to highlight where revisions were made.
Step 9:
Submit materials to the IRB office. Once reviewed, the form will be returned to the investigator. If the IRB
requires additional information, the investigator must respond within 3 weeks.
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