November 2024 SOCRA Source Journal - Journal - Page 71
eased/lifted, the research team
monitored seven additional sites
in the ACT NOW Weaning Trial
in person.
Remote monitoring activities
were successful in identifying
discrepancies between the
electronic data capture and the
EHR/EMR, reasons for study
consent refusal, subject eligibility
issues, and missing/incomplete/
outdated regulatory and study
documents. Additionally, the
remote monitoring process
helped the ACT NOW
leadership team to identify
several protocol violations that
the site did not realize had
occurred. The team was able
to pinpoint misunderstandings
and confusion regarding
critical protocol elements and
documentation of study-speci昀椀c
procedures, especially in the
pharmacy visits regarding drug
administration for the ACT NOW
Weaning trial. By comparing
source documents remotely
monitors discovered that some
sites were not documenting
some protocol procedures
according to the guidance
provided in the study manual
of procedures.
Discovery of these additional
previously undocumented
deviations from the protocol
prompted the ACT NOW
leadership team to employ
additional techniques to monitor
for protocol compliance for the
ACT NOW Weaning protocol
remotely. The study team now
conducts a monthly audit of
the data for every randomized
subject to check for protocol
compliance and accurate data
documentation. Findings from
the audit are reviewed by the
ACT NOW leadership team and
additional measures such as
scheduling additional conferences
with the sites to discuss the issues
have been undertaken to address
issues that may arise during
the interval between full site
monitoring visits.
Through this experience, the
ACT NOW leadership team
identi昀椀ed the following best
practices to be considered when
remote monitoring visits are
being conducted in lieu of
onsite monitoring visits:
•
•
•
Remote monitoring should
focus heavily on participant
safety, data reliability, and
data points essential to
achieving the study’s primary
endpoints or outcomes.
A risk-based approach should
be employed to prioritize
sites for remote monitoring
and should include as
many sites as feasible and
occur at a frequency that
mirrors that of the onsite
monitoring plan.
o Monitor(s) should ensure
that documentation is
robust and meets the
expectations of FDAregulated studies (e.g.,
clear documentation and
rationale provided if/when
monitors must perform
remote monitoring in
place of onsite monitoring,
documentation of protocol
deviations, or other GCP
noncompliance issues that
may have been missed/
delayed in identifying
as a result of the remote
monitoring process).
Corrective action plans
must be developed and
implemented to address
failed performance/improper
study conduct identi昀椀ed
via remote monitoring to
facilitate proper assessment
and resolution.
Discussion
Remote monitoring allows for
clinical research activities to
continue as planned, even during
challenging circumstances,
with the assurance that data
quality and integrity and overall
site accountability can still be
supervised and maintained
until such time as normal
onsite monitoring activities
may resume. Moreover, lessons
learned and best practices
identi昀椀ed via remote site
monitoring have broader
implications for conducting
enhanced routine central
monitoring. See Figure 2 on
next page, Remote Clinical
Monitoring - Lessons Learned.
For example, increased willingness of sites permitting remote
access to the EMR/EHR can
greatly increase the depth,
breadth, and scope of activities
that may now be achievable via
central monitoring.
Waterhouse et al.2 noted
that the COVID-19 pandemic
illustrated the ability of clinical
trials to leverage technology
to reduce the number of inperson visits for trial participants.
The authors reported that
during the pandemic, onsite
monitoring and other related
operational oversight activities
(e.g., site feasibility assessments,
site initiation visits, clinical
monitoring) transitioned to
being conducted remotely or
abandoned altogether. The
ability of most trials to continue
operating despite this led
the authors to suggest that
such in-person visits should
not be a requirement in this
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