November 2024 SOCRA Source Journal - Journal - Page 52
that is then used to meet the regulatory requirements and most importantly, monitor the safety of subjects.
The Adverse Event Log
The Adverse Events (AE) Log
is both vitally important and
very often misunderstood and
not completed appropriately.
Unlike other logs, speci昀椀c FDA
regulations and GCP guidelines
speak about the collection and
documentation of AEs that allows
for reporting to authorities.
These logs facilitate the capture
of data that is then used to meet
the regulatory requirements and
most importantly, monitor the
safety of subjects.
AE Logs (see Diagrams 16 and
17) are the dedicated space
for recording AEs that may
be documented in multiple
places throughout the subjects’
records (e.g., physician notes,
nursing / coordinator notes, lab
or procedure reports, subject
diaries, phone calls or emails).
Through careful documentation,
it can be determined whether
conditions, including those
present at baseline, are
worsening and whether events
across the subject and/or study
are becoming more frequent,
severe, or prolonged.
The protocol will determine when
of昀椀cial AE collection begins.
Some protocols will indicate
that collection begins at consent
and continues throughout
study participation. Others will
call events that occur between
consent and administration
of IP “Pre-Treatment Events,”
with AE collection coinciding
with 昀椀rst IP administration. This
is an important delineation,
as evidenced in a study
conducted at UAMS, in which
AE documentation began at
consent. There was a signi昀椀cant
delay in the study procedure,
so for many months, the study
team was forced to record all
AEs, including surgeries and
hospitalizations unrelated to
study participation.
AE Logs (see Diagrams 16 and 17) are the dedicated space for recording AEs that may be documented in
multiple places throughout the subjects’ records (e.g., physician notes, nursing / coordinator notes, lab or
procedure reports, subject diaries, phone calls or emails). Through careful documentation, it can be
Diagram
16
determined whether conditions, including
those present at
baseline, are worsening and whether events
across the subject and/or study are becoming more frequent, severe, or prolonged.
18
Diagram 17
The protocol will determine when official AE collection begins. Some protocols will indicate that
collection begins at consent and continues throughout study participation. Others will call events that
occur between consent and administration of IP “Pre-Treatment Events,” with AE collection coinciding
with first IP administration. This is an important delineation, as evidenced in a study conducted at UAMS,
in which AE documentation began at consent. There was a significant delay in the study procedure, so for
many months, the study team was forced to record all AEs, including surgeries and hospitalizations
unrelated to study participation.
If not otherwise specified in the protocol and/or ICF, consider subjects to still be on study during their
final 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.
52
SOCRA SOURCE © November
2024 the AE description, report a diagnosis rather than a list of symptoms, if possible (e.g.,
When documenting
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
final diagnosis once determined. See Table 5 for an overview of the documentation of AE start / stop
