November 2024 SOCRA Source Journal - Journal - Page 51
prophylactics) or an AE is a gray area in the regulations. The industry standard, however, is to record all
medications that a subject takes in the interest of safety evaluations and potential drug interactions. Focus
should be placed on collection of Con Meds related to AEs, both treatment and non-treatment related (see
Diagram 15).
Diagram 15
If subjects take a medication while on study, include complete information about the medication. If
Collecting
on should call the
information
should
include
the
Depending
on the
necessary,information
the study team
subject for
details.
For example,
if the
subject notes
thatclinical
they
Con
Meds
considered
to
be
name
and
amount
of
medication
research
site
and
Sponsor,
took an OTC medication for a headache, the recorded information should include the name and amount ofthe
unrelated to the study treatment
and when it was used. This is
Con Med Log may have a 昀椀eld
medication
and when
a perfect
of the
phonecall
call summary
form!
(e.g.,
prophylactics)
or itanwas
AEused.
is Thisa is
perfect
useuse
of the
phone
for the
signature and initials of
a gray area in the regulations.
summary form!
the person completing the form.
If the
exact date
cannothowever,
be determined, enter information as closely as possible, narrowing down to the
The
industry
standard,
or the month
or at least that
the year. IfIf athe
medication
hascannot
been taken
of 昀椀ndings
time
isday
to record
all medications
exact date
be for a considerable
The mostamount
common
a prior
subject
in the
interest
of
enter
onunknown.
review ofHowever,
Con MedaLogs
to atakes
subject
starting
the study,
it determined,
is acceptable for
an information
exact start date to be
stop by
safety
evaluations
and
potential
as
closely
as
possible,
narrowing
monitors/auditors
are:
date is absolutely necessary for exclusionary medication (i.e., wash-out). Always indicate whether the
drug
Focusat
should
towent
the day
or the
month or
druginteractions.
remained ongoing
the time thedown
subject
off the
study.
• Baseline/Historical
be placed on collection of Con
at least the year. If a medication
medications not captured
Meds related to AEs, both
has been taken for a considerable
Depending on the clinical research site and Sponsor, the Con Med Log may have
a field for theespecially
signature
• Medications,
treatment and non-treatment
amount of time prior to a
and
initials
of
the
person
completing
the
form.
OTC,
missing
from
log
related (see Diagram 15).
subject starting the study, it is
• Unknown indications
acceptable for an exact start
If subjects take a medication
date to be unknown. However, a
• Incomplete start/stop dates
17
while on study, include
stop date is absolutely
necessary
• Vague unit, route, frequency
complete information about
for exclusionary medication
• Information captured does
the medication. If necessary,
(i.e., wash-out). Always indicate
not match source
the study team should call the
whether the drug remained
• Dose out of range/nonsensical
subject for details. For example,
ongoing at the time the subject
if the subject notes that they
went off the study.
• Medications not con昀椀rmed
took an OTC medication for
as ongoing at end of study
a headache, the recorded
SOCRA SOURCE © November 2024
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