November 2024 SOCRA Source Journal - Journal - Page 67
JOURNAL ARTICLES
Clinical Site Monitoring in
the Time of COVID-19 and
Beyond: Best Practices in
Remote Site Monitoring on
the ACT NOW Trials
Lauren N. Bradley, MHS;
Margaret Crawford, BS;
Lillian Trochinski, RN, BSN
RTI International
Lauren N. Bradley, MHS
Abstract:
Purpose: Maintaining frequency and quality of clinical site monitoring during the COVID-19 pandemic required
researchers to adapt to travel and clinical site visitation restrictions by structuring robust remote site monitoring
procedures with emphasis on protection of safety, rights, well-being of participants, and minimizing risks to trial
integrity.
Methods: The research team for the HEAL ACT NOW trials designed and implemented a remote clinical site
monitoring plan inclusive of remote site monitoring and chart re-abstraction. Methods included advance outreach
to sites; addressing access and security considerations relevant to review of Protected Health Information over
virtual or remote platforms; implementing remote monitoring visits and virtual review of study documentation and
data; and timely dissemination of 昀椀ndings and visit summary to sites and sponsors
Results: The research team successfully monitored 16 sites over a 6-month period. Three additional independent
visits were conducted with site pharmacies to protect masked treatment assignments. Remote monitoring
effectively identi昀椀ed discrepancies between the Electronic Data Capture data and the Electronic Health Record/
Electronic Medical Record. These included reasons for study consent refusal, subject eligibility issues, missing/
incomplete/outdated regulatory and study documents; undocumented protocol violations; and misinterpretations
of critical protocol elements and documentation of study-speci昀椀c procedures.
Discussion: The research team identi昀椀ed several best practices for consideration in the conduct of remote
monitoring: focus on participant safety, data reliability, and data points essential to achieving primary study
endpoints or outcomes; employ a risk-based approach to site prioritization; include as many sites as feasible;
ensure that visit frequency mirrors that of a traditional onsite monitoring plan; ensure that documentation is robust
and meets the expectations for FDA-regulated studies; and utilize corrective action plans to address performance/
improper study conduct and facilitate proper assessment, resolution, and mitigation of future similar conduct.
Conclusions: Remote clinical site monitoring can be an effective tool for maintaining trial momentum and proper
trial conduct under de昀椀ned circumstances and in situations where traditional site monitoring is not feasible. While
it cannot fully supplant all aspects of onsite monitoring, it has proven an invaluable tool during the pandemic when
physical monitoring was impossible. Remote monitoring allows essential clinical research activities to continue
during challenging circumstances, with assurance that data quality, integrity, and overall site accountability are
supervised and maintained. Virtual site monitoring highlights the need for traditional clinical monitoring techniques
to adapt to/advance with the capabilities and expectations of the ever-changing digital age.
SOCRA SOURCE © November 2024
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