UTHSCSA Internal/External AE/UP Tracking Log
The policy of UTHSCSA IRB is that investigators must promptly submit any problem or event which in the opinion of the local investigator was unanticipated,
probably, or definitely related to the research procedures and physical or psychological harm was serious or the event suggests that the research places
subjects or others at greater risk than was previously known or recognized. Most IND safety reports and many internal events do not meet these criteria and do
not require submission to the IRB individually, but must be reported in summary form at the time of the next continuing review. If the event is increases risk due to an
unanticipated problem related to the study, you must submit a UPIRSO Report form for each event or set of events (if increased frequency for example).
Name
Dept/ Office
Email
Phone
Pager
1. Protocol Number:
2. Title:
3. Events:
EVENT
ID
Identifying Number
(AE number, subject
number or UPIRSO
Unique ID Number
(I) = Initial report
(F)= Follow-up
I
F
Brief Name of Event
THREE CRITERIA
AMENDMENT
PI
MAKES FINAL
DETERMINATION
If any yes is answered in all three questions, you must report this event to
the IRB promptly defined as within 7 days for internal and 14 for external -48
hours if local life threatening or fatal using an UPIRSO Reporting Form.
Otherwise use of this form is appropriate for tracking-PI initial each row.
Was the event
Was the event
Was physical or
unanticipated: unexpected
probably, or
psychological harm
(in terms of nature,
definitely
serious?
severity, or frequency)
related to
Does the event suggest
given (a) the research
participation in
that the research places
procedures in the protocolthe research
subjects or others at a
related documents, e.g.,
e.g., related to
greater risk of harm than
informed consent
procedures?
was previously known or
document; and (b) the
Yes/No
recognized (if serious
characteristics of the
physical, psychological,
subject population being
economic, or social harm
studied?
this is more likely yes too)?
Yes/No
If so,
Based on your
judgment as PI,
should the consent
form/process or the
protocol be revised?
Yes/No
(If Yes, submit an
amendment request
if not already
submitted)
(If No, the other
three questions
to the left should
not all be yes:
Change one or
explain.)
PI Initials/ Date
(Or in some way
indicate that the
PI made all
determinations)
Insufficient Information
Insuff. Info
Yes
Yes
Insufficient Information
Serious
No
No
Yes
No
No
If yes, was event related to:
Drug
I
F
Insufficient Information
Insuff. Info
No
Yes
No
Device
NA
Yes
No
Amendment:
Not Required
Requested
Insufficient Information
Serious
Yes
Greater risk
Yes
Greater risk
Yes
Yes
No
No
If yes, was event related to:
Drug
Device
NA
Yes
No
Amendment:
Not Required
Requested
If insufficient
information for
any
determination do
not submit follow and
consider
submitting when
more information
is available.
I
F
Insufficient Information
Insuff. Info
Insufficient Information
Serious
Yes
No
Yes
No
Yes
Yes
No
No
If yes, was event related to:
Drug
I
F
Insufficient Information
Insuff. Info
Yes
Yes
No
F
Insufficient Information
Insuff. Info
Yes
No
No
No
No
If yes, was event related to:
F
Insufficient Information
Insuff. Info
No
Yes
No
F
Insufficient Information
Insuff. Info
No
Yes
No
No
If yes, was event related to:
Amendment:
Not Required
Requested
Yes
No
Amendment:
Not Required
Requested
Device
NA
Yes
No
Amendment:
Not Required
Requested
Insufficient Information
Greater risk
Yes
Yes
No
No
If yes, was event related to:
Device
NA
Yes
No
Amendment:
Not Required
Requested
Insufficient Information
Greater risk
Yes
Yes
No
No
If yes, was event related to:
Drug
5. Summary of events in light of the entire study in the opinion of the local investigator:
Greater risk
No
Serious
Yes
NA
Yes
Drug
I
Device
Yes
Serious
Yes
No
Insufficient Information
Drug
I
Greater risk
Yes
Serious
Yes
NA
Yes
Drug
I
Device
Yes
Insufficient Information
Serious
No
Greater risk
Device
NA
Yes
No
Amendment:
Not Required
Requested