November 2024 SOCRA Source Journal - Journal - Page 53
If not otherwise speci昀椀ed in the
protocol and/or ICF, consider
subjects to still be on study
during their 昀椀nal study visit,
meaning that events noted at
this time should be added to
the log for assessment. Further
follow-up would depend on the
seriousness and relatedness of
the AE.
When documenting the AE
description, report a diagnosis
rather than a list of symptoms,
if possible (e.g., upper
respiratory infection vs. runny
nose, coughing and shortness
of breath; C. Diff vs. diarrhea,
fever and abdominal pain). If
you can only report individual
symptoms, that is acceptable,
as long as you record 昀椀nal
diagnosis once determined.
See Table 5 for an overview of
the documentation of AE start/
stop dates and description.
Depending on the protocol,
the clinical research site and
the Sponsor, the study team
may not be required to report
abnormal laboratory values
unless they are deemed to be
“Clinically Signi昀椀cant”. As with
all research, “not documented,
not done,” so, the clinical
investigator or designee should
review the lab report/values,
record their assessment and
add this source documentation
to subject 昀椀les.
As discussed, our clinical
research sites use the Medical
History CRF exclusively to
document baseline conditions
at screening, however, other
clinical research sites add
these baseline events to AE
Logs as well, allowing for
grading/assessment for future
comparisons. Each clinical
research site should comply
with the procedures indicated
by the Sponsor.
If baseline events worsen during
the study, best practice is to
TABLE 5
The Adverse Event Log (Start-Stop-Description)
•
•
Follow AE collection period outlined in the protocol
Start of AE collection will either begin at:
o Consent
or
o IP administration
- Some studies de昀椀ne a Pre-Treatment Event as: “Any
untoward medical occurrence in a patient or subject who
has signed informed consent to participate in a study but
before administration of any study [treatment].”
•
Final AE collection will continue through the end of the study
period as stated in the protocol
o Final study visit is considered on study, so events discovered
during this visit should be documented
o If event is stable and/or unrelated, no further follow-up
is required
Description of AE:
o Document the diagnosis or syndrome, not the sign or
symptom
o If the constellation of signs and/or symptoms cannot be
characterized as a single diagnosis or syndrome, document
the information currently available
o If diagnosis is subsequently established, report as follow-up
o Use consistent terminology, based on the protocol
o Document abnormal laboratory results if clinically signi昀椀cant
(some studies), along with evidence of clinical investigator
review, assessment and determination; add to subject 昀椀le/
source
•
add the event to the AE Log as
a new event with the start date
as the date severity increased.
This also applies to AEs that
worsen during the study. Add
the end date for the previous
grade and create a new event
with the start date as the
date the condition worsened.
Always enter AEs to the highest
possible level of detail or
granularity.
When determining severity
of an event, it is important to
remember that “severe” does
not equal “serious”. Severity
is equivalent to intensity or
grade, while seriousness, based
on outcome of the event or
the action taken, is the driver
behind reporting to the Sponsor
and the FDA.
The assignment of “serious” is
usually associated with events
that threaten life or functioning.
For example, visiting the
emergency department for a
laceration, receiving stitches,
and going home might be
severe in terms of intensity/
grade, however, it does not
meet the threshold for a
“serious” event. If, however,
that laceration also came with
fractures and signi昀椀cant blood
loss requiring surgery and an
overnight hospital stay, this
event would become serious
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