November 2024 SOCRA Source Journal - Journal - Page 69
with application extending far
beyond the pandemic period.
Methods: Traditional site
monitoring involves clinical
research coordinators/monitors
traveling in person to a clinical
site, typically staying for 2-3
days. During this visit, monitors
engage in various activities
(e.g., reviewing participant
binders and assessments,
essential regulatory documents,
the EMR, or other clinical
care–oriented documents such
as laboratory results reports)
and meet with core study
staff (principal investigators,
research coordinators, research
pharmacist, etc.) to assess
trial conduct. The COVID-19
pandemic resulted in the
enactment of various national,
state, local, and institutional
restrictions that both prohibited
travel and restricted access to
clinical settings to those outside
of essential staff. Therefore, the
ability to gain in-person access
to trial sites and personnel
made traditional site monitoring
essentially impossible.
The goal of site monitoring is to
ensure that the clinical study is
being conducted in accordance
with the protocol, FDA
regulations, and International
Council on Harmonisation of
Technical Requirements for
Registration of Pharmaceuticals
for Human Use (ICH) Good
Clinical Practice (GCP)
guidelines. With the pandemic
eliminating opportunities for
traditional onsite monitoring,
the ACT NOW leadership
team worked to preemptively
establish and implement a
remote clinical site monitoring
plan with emphasis on protection
of the safety, rights, and well-
being of human participants,
and minimization of risks to trial
integrity. Remote monitoring
was conducted through virtual
routine site monitoring and
through a chart re-abstraction
process done for a subset of
enrolled participants at each site.
Remote monitoring methods
employed were numerous and
included the steps described
below. See Figure 1, Remote
Clinical Monitoring Methods.
Step 1 - Develop a remote
clinical monitoring plan.
A remote clinical monitoring
plan should be created as
either a standalone plan or as
an addendum to a traditional
clinical site monitoring plan.
A comprehensive remote clinical
monitoring plan should rely on
a combination of centralized
and virtual monitoring activities.
Clinical monitors should work
closely with study sponsors to
determine the frequency and
scope of the remote monitoring
approach based on the unique
characteristics of the trial in
question. Attributes such as
objective, purpose, design,
complexity, blinding, size,
timeline, and endpoints of the
study and prior experience,
Figure 1. Remote Clinical Monitoring Methods
Methods
Develop Remote
Monitoring Plan
o
o
o
o
Pre-determine frequency and scope of remote monitoring visits
Establish outline of planned centralized and virtual monitoring activities
Delineate speci昀椀c remote monitoring activities to be conducted
Obtain proper site and sponsor approvals
Advance Site
Outreach for
Remote Visit
o Collaborate with sites to schedule remote monitoring visits via
HIPAA-compliant webinar platform
o Con昀椀rm/abide by site-speci昀椀c Standard Operating Procedures or
monitoring requirements
o Prepare 昀椀ndings documentation, enrollment summaries, query reports,
etc., necessary for conducting the site visit
Address Access
and Security
Considerations
o Use online platforms, screen sharing, secure 昀椀le sharing platforms, or
other web-based platforms for viewing documents and information
o Use audiovisual technology (photos, FaceTime, or other video-based
calling) for viusal inspection of facilities (if site allows)
o Request/gain remote access to the EMR/EHR for subset of participants
to be monitored (if site allows)
Advance Review
and Visit
o Review/reconcile site data and source documentation against the
EDC system to verify data accuracy
o Review regulatory documentation and protocol compliance through
meeting with key staff personnel documenting noted discrepancies
o Review with site any relevant documentation and 昀椀ndings as necessary
Disseminate
Findings and
Conduct
Follow-Up
o Finalize 昀椀ndings report and disseminate to site and sponsor
o Issue queries and provide a follow-up letter indicating completion of
the monitoring visit
o Follow up with site until resolution of outstanding correction, updates,
or action items identi昀椀ed via remote monitoring
SOCRA SOURCE © November 2024
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