November 2024 SOCRA Source Journal - Journal - Page 73
are proving invaluable in terms
of sites being able to upload
redacted source documentation
expeditiously and safely for
review by the site monitors
while preserving Protected
Health Information/personally
identi昀椀able information (PHI/
PII). Virtual meeting platforms
such as BlueJeans® and
ZoomTeleHealth® can be used
with con昀椀dence for debrie昀椀ngs
given their compliance with
the Health Insurance Portability
and Accountability Act (HIPAA).
Study leadership teams and data
coordinating centers may be able
to harness this new era in data
sharing/data access to move
beyond standard querying and
edit checks to a point of verifying data accuracy in close to
real time.
From a cost and material resource
standpoint, traditional onsite
clinical monitoring is resource
intensive when considering not
only labor hours but costs of
travel, lodging, and per diem for
the monitor(s); time away from
work; and increased burden
on site study staffc. Remote
monitoring also allows for
additional staff who otherwise
may not have attended a
“visit” because of logistical or
budgetary constraints, but whose
attendance and expertise may
prove invaluable in addressing
site-speci昀椀c concerns, to partake
(i.e., lead data managers,
protocol PIs, and study sponsors).
It is worth noting that onsite
monitoring does not provide
any guarantees with respect to
effectiveness of data quality,8
as items and issues can still be
missed or overlooked whether
a monitor is on site or not. In
their 2021 paper, Yamada et al.8
compared the effectiveness
of risk-based monitoring with
a remote monitoring system
with that of traditional onsite
monitoring. Their research
concluded that remote riskbased monitoring presents
as an effective alternative to
traditional onsite monitoring
with remote monitoring able to
detect critical data and process
errors just as well as onsite
monitoring with 100% source
data veri昀椀cation.
Fu et al.9 conducted similar
research comparing hybrid
monitoring (inclusive of a
remote monitoring component)
with onsite monitoring alone
and concluded that the hybrid
model succeeded in ensuring
timely detection of monitoring
issues, improved ef昀椀ciency,
and reduced clinical trial costs,
thus suggesting that this mode
should be applied more broadly
in future clinical trials research.
In terms of overall ef昀椀ciency
of trial conduct, remote
monitoring offers numerous
bene昀椀ts including the ability
to access and evaluate visual
data more quickly and more
often, generate needed queries,
and identify instances where
subsequent onsite monitoring
may be necessary.9
The ACT NOW leadership team
recognizes that some clinical
site monitoring activities may be
challenging to assess remotely.
These include assessing
facility security, storage of
investigational product(s) and
other study supplies, sample
storage (if biospecimens are
involved) adequacy of research
facilities, and demonstrated
performance.
Navigating various site EMR/
EHR systems independently
without guidance from the
local site staff can pose unique
challenges for monitors. Some
sites had intensive training
requirements that each monitor
needed to complete before
gaining access to the system.
Even with the training, each site
system may have its own unique
operating and navigating
features that require familiarity
with the system to utilize the
system. These functionalities
may not be intuitive to the new
monitor user accessing this
system for the 昀椀rst time, and
therefore may be more time
intensive compared to having a
local staff member navigate the
system on site.
Not all sites were able to
provide direct access to their
EMR/EHR system and those
sites could only provide
snapshots of their source
documentation (e.g., PDF 昀椀les,
screenshots, handwritten forms,
or documents). This increases
site burden and creates
vulnerabilities like uploading
unredacted source documents
and causing unintended PHI/
PII disclosures. Upon review of
the submitted documentation,
monitors discovered that they
were unable to verify some
data points on the Case Report
Form as omitted in the original
submission. As a result, there
were some delays in continued
veri昀椀cation of data points
against source documents as
sites were requested to submit
additional documentation.
Inevitably, there will be
instances in which research
sites will be unable to provide
site monitors with either
remote access to their EMR/
EHR or with access to redacted
SOCRA SOURCE © November 2024
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