November 2024 SOCRA Source Journal - Journal - Page 74
medical records through online
昀椀le-sharing platforms. In these
cases, site monitoring should
take place in person as remote
monitoring would not be able
to ensure the same degree of
quality assurance. Finally, there
were also some challenges for
sites in technological information
security practices, and several
sites were not permitted to use
certain HIPAA-compliant webinar
platforms so alternate measures
were required. These limitations
should always be weighed
against the evidence of other
activities to ascertain overall
risk(s) to study conduct and
integrity before deeming remote
monitoring an acceptable
alternative activity.
•
For studies in which there is
increased risk to subjects or
inexperienced personnel, an
onsite monitoring visit should be
conducted prior to consideration
of remote monitoring. Should
remote monitoring need to
occur, it is imperative that the
monitor work in concert with
study leadership to ensure that
expectations are met for FDAregulated studies (if applicable)10:
Conclusion: As evidenced by
its use on the ACT NOW trials,
remote clinical site monitoring
can be an effective tool for
maintaining trial momentum
and proper trial conduct under
de昀椀ned circumstances (e.g.,
experienced clinical investigator
with seasoned site personnel)
and in situations where
traditional site monitoring is not
possible. Although remote site
monitoring cannot fully supplant
the utility and function of onsite
monitoring, it nevertheless
proved to be an invaluable tool
during pandemic times, when
travel and access to clinical sites
has been severely limited, if not
altogether infeasible. The future
will require that institutions
and industry continue to offer
•
74
Carefully document situations
where monitors were unable
to access or had to delay
monitoring of a clinical
site, opting for remote
monitoring instead. When
intended onsite monitoring
is not possible, the reason
should be documented and
available for review.
•
Include documentation of
any protocol deviations or
other GCP noncompliance
issues identi昀椀ed at clinical
sites if delayed identi昀椀cation
was a result of postponed
onsite monitoring and not
identi昀椀ed via remote site
monitoring.
If the remote monitoring visit
shows evidence of failed
performance, especially if
signi昀椀cant or critical in nature,
additional actions must be
taken to assess and resolve
the situation more fully.
These may include requests
for additional documents,
interviews with the PI or staff,
or an onsite visit as soon as is
feasible.
SOCRA SOURCE © November 2024
support for electronic research
documentation and improve
upon the systems required
to manage it. Additionally,
the establishment of uniform
practices and guidelines for
remote trial conduct and
monitoring is needed. Finally, at
the site level, there must be an
investment into the appropriate
infrastructure needed to
implement and maintain
secure document management
capable of remote access.4
The COVID-19 pandemic may
have been the impetus that
kickstarted a pivot toward
remote monitoring, but the
practice has broad, far-reaching
implications beyond the
pandemic in terms of cost and
resource savings, minimization
of site burden, ef昀椀ciency of
trial conduct, and overall data
and trial quality. Remote site
monitoring highlights the
need for traditional clinical
monitoring techniques to adapt
to/advance with the capabilities
and expectations of the everchanging digital age.
