JOURNAL ARTICLESClinical Site Monitoring inthe Time of COVID-19 andBeyond: Best Practices inRemote Site Monitoring onthe ACT NOW TrialsLauren N. Bradley, MHS;Margaret Crawford, BS;Lillian Trochinski, RN, BSNRTI InternationalLauren N. Bradley, MHSAbstract:Purpose: Maintaining frequency and quality of clinical site monitoring during the COVID-19 pandemic requiredresearchers to adapt to travel and clinical site visitation restrictions by structuring robust remote site monitoringprocedures with emphasis on protection of safety, rights, well-being of participants, and minimizing risks to trialintegrity.Methods: The research team for the HEAL ACT NOW trials designed and implemented a remote clinical sitemonitoring plan inclusive of remote site monitoring and chart re-abstraction. Methods included advance outreachto sites; addressing access and security considerations relevant to review of Protected Health Information overvirtual or remote platforms; implementing remote monitoring visits and virtual review of study documentation anddata; and timely dissemination of 昀椀ndings and visit summary to sites and sponsorsResults: The research team successfully monitored 16 sites over a 6-month period. Three additional independentvisits were conducted with site pharmacies to protect masked treatment assignments. Remote monitoringeffectively 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 These included reasons for study consent refusal, subject eligibility issues, missing/incomplete/outdated regulatory and study documents; undocumented protocol violations; and misinterpretationsof critical protocol elements and documentation of study-speci昀椀c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 remotemonitoring: focus on participant safety, data reliability, and data points essential to achieving primary studyendpoints 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 robustand 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 propertrial conduct under de昀椀ned circumstances and in situations where traditional site monitoring is not feasible. Whileit cannot fully supplant all aspects of onsite monitoring, it has proven an invaluable tool during the pandemic whenphysical monitoring was impossible. Remote monitoring allows essential clinical research activities to continueduring challenging circumstances, with assurance that data quality, integrity, and overall site accountability aresupervised and maintained. Virtual site monitoring highlights the need for traditional clinical monitoring techniquesto adapt to/advance with the capabilities and expectations of the ever-changing digital age.SOCRA SOURCE © November 202467
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