November 2024 SOCRA Source Journal - Journal - Page 50
Beginning at baseline/screening,
use the Con Med Log to
document all medications the
subject is currently taking, using
one line per medication (see
Diagram 14). At subsequent
visits, record new meds, and
document changes in or
discontinuation of previously
listed meds, adding a new
entry/row, if necessary, to
capture changes.
It is important to record an
accurate indication (reason
for use), as this could be tied
to AEs. Indication, de昀椀ned
as, “A medical condition
that a medicine is used for;
a sign, symptom, or medical
condition that leads to
the recommendation of a
treatment….” should not be
confused with intended use,
which is synonymous with
labeling of the product. If the
reason for use is truly unknown,
enter “unk” or “unknown” to
avoid a blank 昀椀eld. For multiple
indications, some recommend
listing the medication again
with each indication as a new
line or row.
•
•
•
Dose and Unit - amount of
medication taken at one
speci昀椀c time, it is most
often expressed in metric
mass units (e.g., milliliters,
milligrams) vs. the apothecary
system (e.g., teaspoons,
ounces).
Route - the way by which
a substance is taken into
the body
Frequency - number of
times something should
be administered/taken
In order to eliminate confusion,
it is recommended to document
medications using generic
Just as indication should not
names (e.g., ibuprofen). If the
be confused with intended use,
generic name is unknown,
dose should not be confused
record the brand name (e.g.,
with dosage, which is the broader
Advil, Midol, Motrin). For 昀椀xed
term to encompass intended
dose combination medications,
use, speci昀椀c
amount, route
Beginning
at baseline
/ screening,
Con Med
Log to document
all medications
theand
subject is
indicate
the strength
if known.
For use
eachthe
medication
and
frequency (i.e., instructions).
administration,
record:
currently taking, using one line per medication (see Diagram 14). At subsequent visits, record new m
and document changes in or discontinuation of previously listed meds, adding a new entry / row, if
necessary, to capture changes.
Diagram 14
50
SOCRA SOURCE © November 2024
In order to eliminate confusion, it is recommended to document medications using generic names (e
