November 2024 SOCRA Source Journal - Journal - Page 72
post-COVID-19 era. Instead, a
centralized, risk-based approach
to monitoring, inclusive of
virtual/remote visits, should be
adequate, a sentiment further
supported by FDA in its 2013
guidance document, Oversight
of Clinical Investigations – a RiskBased Approach to Monitoring.5
Being able to gain access to
EMR/EHR data prior to meeting
with site personnel allows study
monitors to preemptively identify
and address issues in a manner
that might not be possible
if said issues were identi昀椀ed
during a site monitoring visit.
Identi昀椀cation of such issues in
advance of site monitoring visits
affords more time to explore the
reasons for them and to prepare
mitigation plans. Williams et al.
report that sponsors and auditors
performing remote monitoring
at their research site (UT
Southwestern Comprehensive
Cancer Center) commented
on experiencing increased
responsiveness of clinical
research personnel, greater ease
in tracking clinical documentation
through use of the EMR and
increased availability of study
teams for scheduling debriefs/
exit interviews.4
The advent of enhanced clinical
research tech solutions such as
electronic regulatory and patient
binders has furthered remote
clinical monitoring capability
and feasibility. For example, the
Florence eRegulatory platform®
allows for an electronic version
of the traditional paper-based
regulatory binder maintained
at clinical trials sites to manage
various trial-associated
regulatory documents. Electronic
binder systems address common
trial management challenges
pertaining to digital compliance
issues, onsite document storage
limitations, and information
sharing between and among
clinical sites, sponsors, and
Contract Research Organizations,
all while maintaining 21 Code
of Federal Regulations, Part 11
compliance.7
Online 昀椀le-sharing platforms such
as Box, DropBox, and SharePoint
Figure 2. Remote Clinical Monitoring – Lessons Learned
Remote monitoring can be an effective
tool for maintaining trial momentum
and proper trial conduct under de昀椀ned
circumstances and where traditional site
monitoring is not possible.
Advance EMR/
EHR access allows
for preemptive
identi昀椀cation and
addressing of noted
issues and allows time
for preparation of
mitigation plans.
Scope of activities
achievable via central
monitoring is enhanced by
site willingness to permit
remote EMR/EHR.
Site Monitoring
Lessons Learned
Allows monitors to
move beyond standard
querying/edit checks
to veri昀椀cation of data
accuracy in real time.
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SOCRA SOURCE © November 2024
Web-based 昀椀lesharing allows for
expeditious and safe
upload and review
of redacted source
documentation in
real time.
