August 2024 SOCRA Source Journal - Journal - Page 49
The Concomitant Medication
Log
Concomitant Medications (Con
Meds) are medicinal products
(i.e., prescription and over-thecounter [OTC] products, dietary
supplements) that a subject
takes while participating in a
study. These may be drugs
for the same indication being
studied OR for pre-existing or
concurrent conditions. Ideally,
the protocol should specify
concomitant medications that
are and are not allowed if drugdrug interactions are expected.
Like DOA Logs, there are no
regulations governing the 昀椀ling
and/or maintenance of Con
Med Logs. FDA guidances
do, however, mention
“Concomitant Medications”,
“Concomitant Therapy”, and
“Concomitant Treatments,”
and GCP guidelines mention
reporting Con Meds as per the
protocol on the CRFs.
Documentation of Con Meds
is imperative for many reasons.
Con Meds may interact with
the study treatment, leading
to faulty conclusions regarding
safety and ef昀椀cacy and
impacting a subject’s ability to
complete the trial or meet trial
obligations. Con Meds may
also indicate a condition (like
hypertension) which potentially
affects the pharmacokinetics
of the study drug. The earliest
indication of an adverse
event (AE) or serious adverse
event (SAE) may have been
self-treatment with an OTC
medication
TABLE 4
The Concomitant Medication Log
•
Record all medications the subject is taking, beginning at
baseline/screening
•
At subsequent visits:
o Record new medications
o Record changes or discontinuation of previous medications
•
Record the drug’s generic name:
o If unknown, record the brand name
•
Include only one medication per line
•
For 昀椀xed dose combination medications:
o Indicate the strength
•
For multiple indications:
o List medication again with each indication as a new line
or row
•
Record the reason for use:
o If unknown, enter “unknown”
•
For each medication and administration, record:
o Dose
o Unit
o Route
o Frequency
•
Record changes in dose, unit, route or frequency on a new line
•
Start, stop, and ongoing:
o Medications with lengthy historical use may have
incomplete dates
o Medications taken during the study should have
complete start dates
o Prior medications that are exclusionary should have
start and stop dates
o For medications where the exact date is unknown:
- If day is unknown: Enter the 昀椀rst day of the month
(e.g., 01MAY2022)
- If day and month are unknown: Enter the 昀椀rst day
of the 昀椀rst month for both 昀椀elds (e.g., 01JAN2022)
- If day, month and year are unknown: Use the best
estimate for the year
•
Indicate whether the drug is ongoing at the end of the study
Table 4 provides an overview
of the Concomitant Medication
Log.
SOCRA SOURCE © November 2024
49
