November 2024 SOCRA Source Journal - Journal - Page 70
if any, with the site, should
all be carefully considered. A
robust plan should document
the circumstances under which
remote monitoring will be
used and the conditions under
which onsite monitoring will be
required and should also clearly
delineate the speci昀椀c monitoring
activities to be conducted.
Finally, necessary review and
approval of the plan should
occur prior to 昀椀nalization by
key players such as the sponsor,
clinical investigator, study team,
clinical research associates, main
client/funder, and any other
relevant parties as required.
Step 2 - Advance site outreach
and planning. Remote clinical
monitoring visits should be
scheduled according to the
frequency outlined in the plan.
Working with the site, the clinical
research monitor(s) should
arrange the study monitoring
visit window and con昀椀rm the
date and anticipated length
of the visit in writing with
the relevant site staff (e.g.,
Principal Investigators (PIs),
study coordinator, research
pharmacist). As would be the
case with a traditional onsite
visit, the clinical research
monitor(s) should be available for
reviewing relevant documents,
reports, and correspondence in
preparation for the monitoring
visit. Additionally, the clinical
research monitor(s) should
coordinate with appropriate
colleagues, subcontracts, or the
sponsor to gain a clear handle
on the status of any outstanding
items (e.g., data clari昀椀cation
forms/electronic queries, Serious
Adverse Event reports) to ensure
that appropriate follow-up can
occur during the remote visit.
70
Step 3 - Address access and
security considerations.
It is important to note that
in the case of remote clinical
monitoring, additional
scheduling time should be built
into the planning process to
allow for completion of data
access agreements or user
acceptance agreements (e.g.,
for gaining remote EHR/EMR
access), discussions surrounding
data security issues, and to allow
for site preparation of materials
to be shared via any sitedesignated secure 昀椀le sharing
platform (e.g., documents that
must be redacted and uploaded
to the site’s secure portal for
sharing). It is highly likely that a
monitor’s company or institution,
or even the sponsor, may require
a review/vetting and approval
process to be completed by
internal privacy of昀椀cers, legal
counsel, or technology services
personnel prior to a monitor
gaining access to external
systems and certain data or 昀椀lesharing platforms.
Step 4 - Advance review of
site source documentation
and debrief. A signi昀椀cant
advantage of remote clinical
monitoring is that unlike onsite
visits, where monitors are
normally restricted to 1-2 days
physically on site, the remote
monitoring process often
allows (pending clinical site
policies surrounding monitoring)
monitors to have remote access
to the EMR/EHR, eRegulatory
binders, and other essential
study documents for a longer
window of time. This expanded
access combined with access to
source documentation via secure
昀椀le-sharing platforms fosters an
opportunity for clinical research
monitors to complete advance
SOCRA SOURCE © November 2024
review and provide a chance for
a “deep dive” into participant
data that can occur well before
the scheduled debrief with
clinical site staff. The monitoring
“visit” thus transitions more into a
monitoring “period” allowing for
a far more comprehensive look at
study data than can a visit that is
typically limited to a 2-day period
on site. Access to this information
comes with an important caveat:
monitors should never print,
email, download, or otherwise
share data or records to which
they are provided access.
Step 5 - Disseminate 昀椀ndings
and follow up. Following the
remote clinical monitoring visit,
as is done with traditional onsite
monitoring, a site monitoring
report or trip report is prepared
noting any discrepancies or other
issues identi昀椀ed during the visit.
The 昀椀nal report is disseminated
via email to both the site and
study sponsor, as applicable. Per
procedure, necessary queries
may be issued in the electronic
database and the monitor
sends a follow-up letter or email
indicating completion of the
monitoring visit. Monitors should
follow up with the site until all
identi昀椀ed discrepancies or issues
have been effectively resolved.
Results: Using the abovedescribed approach, the research
team successfully monitored 12
sites in the ACT NOW ESC Trial
and 4 sites in the ACT NOW
Weaning Trial over a 6-month
period. Three more independent
visits were conducted with
the site pharmacies for the
ACT NOW Weaning trial to
protect the masked treatment
assignments. Once travel and
clinical visit restrictions related
to the COVID-19 pandemic were
