February 2024 SOCRA Source Journal - Journal - Page 22
number of procedures to be
completed in a typical visit
led us to develop a worksheet
(Table 2) to ensure coordinators
do not neglect administrative
tasks in the midst of busy clinic
days. Tracking subject visits
on a shared calendar with
assigned colors for each clinic
helps our manager determine
at a glance which teams may
need additional staffing.
Recording visits in a clinical trial
management system (CTMS)
within 24 hours of the visit is
crucial to our finance team when
reviewing charges to be billed
to insurance or sponsors and
also helps reconcile payments
received from sponsors.
It is necessary to have proactive
communication not just within
the research department and
cancer center but also with
other hospital departments.
For instance, investigational
products that activate immune
cells and have the potential to
spark a systemic inflammatory
response may require an
inpatient stay to monitor
for such reactions. Prior to a
subject’s admission, we would
meet with inpatient nursing
staff to provide information
TABLE 2:
SAMPLE OF COORDINATOR VISIT CHECKLIST
Screening
• Consent process note in EMR
• Check of consent by 2nd coordinator
• Upload consent to EMR
• Update Clinical Trial Management System (CTMS)
• Update research tab in EMR
• Complete eligibility checklist (from prtocol or sponsorprovided form)
• Check of eligiblity by 2nd coordinator
• Schedule C1D1
• Request IP from Investigational Pharmacy
• Update shared Outlook calendar
On-Treatment Visit
• Document visit in EMR
• Schedule next visit(s)
• Update Aes and obtain investigator signature
• Update CTMS
• Request travel reimbursment
• Prep for next visit
○ Update Outlook calendar
○ Print subject diary
○ Request IP
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SOCRA SOURCE © May 2023
about the mechanism of
action of the drug as well as
the monitoring requirements,
including timed vitals, labs, and
ECGs and contact information
for the research coordinators.
Based on the acuity of care,
the nursing manager would
assign staff appropriately for
the anticipated admission. The
research coordinator would
also be available at the time
of treatment administration
to provide help with timed
vitals and ECGs, which meant
additional planning to ensure
both inpatient and outpatient
visits had a coordinator
assigned.
Targeted oncology agents
and immunotherapy have
revolutionized cancer treatment
in recent years, but many
of these agents have been
associated with ocular adverse
events and require monitoring
by an ophthalmologist.2 We
have contracted with a local
ophthalmologist who is affiliated
with our hospital network and
performs ophthalmologic exams
for our research subjects. This is
an additional procedure to be
scheduled by the coordinator
and is an additional site to
be visited by the subject,
but having a dedicated
ophthalmologist who is willing
to accommodate appointment
requests on short notice has
allowed us to quickly assess
adverse events and minimize
the time subjects are holding
their dose.
In addition to the typical
challenges of complex, fastpaced trials, we were also
dealing with the challenges
of the COVID-19 pandemic.
Most of our subject visits had
returned to in-person visits at