are proving invaluable in termsof sites being able to uploadredacted source documentationexpeditiously and safely forreview by the site monitorswhile preserving ProtectedHealth Information/personallyidenti昀椀able information (PHI/PII). Virtual meeting platformssuch as BlueJeans® andZoomTeleHealth® can be usedwith con昀椀dence for debrie昀椀ngsgiven their compliance withthe Health Insurance Portabilityand Accountability Act (HIPAA).Study leadership teams and datacoordinating centers may be ableto harness this new era in datasharing/data access to movebeyond standard querying andedit checks to a point of verifying data accuracy in close toreal time.From a cost and material resourcestandpoint, traditional onsiteclinical monitoring is resourceintensive when considering notonly labor hours but costs oftravel, lodging, and per diem forthe monitor(s); time away fromwork; and increased burdenon site study staffc. Remotemonitoring also allows foradditional staff who otherwisemay not have attended a“visit” because of logistical orbudgetary constraints, but whoseattendance and expertise mayprove invaluable in addressingsite-speci昀椀c concerns, to partake(i.e., lead data managers,protocol PIs, and study sponsors).It is worth noting that onsitemonitoring does not provideany guarantees with respect toeffectiveness of data quality,8as items and issues can still bemissed or overlooked whethera monitor is on site or not. Intheir 2021 paper, Yamada et al.8compared the effectivenessof risk-based monitoring witha remote monitoring systemwith that of traditional onsitemonitoring. Their researchconcluded that remote riskbased monitoring presentsas an effective alternative totraditional onsite monitoringwith remote monitoring able todetect critical data and processerrors just as well as onsitemonitoring with 100% sourcedata veri昀椀cation.Fu et al.9 conducted similarresearch comparing hybridmonitoring (inclusive of aremote monitoring component)with onsite monitoring aloneand concluded that the hybridmodel succeeded in ensuringtimely detection of monitoringissues, improved ef昀椀ciency,and reduced clinical trial costs,thus suggesting that this modeshould be applied more broadlyin future clinical trials research.In terms of overall ef昀椀ciencyof trial conduct, remotemonitoring offers numerousbene昀椀ts including the abilityto access and evaluate visualdata more quickly and moreoften, generate needed queries,and identify instances wheresubsequent onsite monitoringmay be necessary.9The ACT NOW leadership teamrecognizes that some clinicalsite monitoring activities may bechallenging to assess remotely.These include assessingfacility security, storage ofinvestigational product(s) andother study supplies, samplestorage (if biospecimens areinvolved) adequacy of researchfacilities, and demonstratedperformance.Navigating various site EMR/EHR systems independentlywithout guidance from thelocal site staff can pose uniquechallenges for monitors. Somesites had intensive trainingrequirements that each monitorneeded to complete beforegaining access to the system.Even with the training, each sitesystem may have its own uniqueoperating and navigatingfeatures that require familiaritywith the system to utilize thesystem. These functionalitiesmay not be intuitive to the newmonitor user accessing thissystem for the 昀椀rst time, andtherefore may be more timeintensive compared to having alocal staff member navigate thesystem on site.Not all sites were able toprovide direct access to theirEMR/EHR system and thosesites could only providesnapshots of their sourcedocumentation (e.g., PDF 昀椀les,screenshots, handwritten forms,or documents). This increasessite burden and createsvulnerabilities like uploadingunredacted source documentsand causing unintended PHI/PII disclosures. Upon review ofthe submitted documentation,monitors discovered that theywere unable to verify somedata points on the Case ReportForm as omitted in the originalsubmission. As a result, therewere some delays in continuedveri昀椀cation of data pointsagainst source documents assites were requested to submitadditional documentation.Inevitably, there will beinstances in which researchsites will be unable to providesite monitors with eitherremote access to their EMR/EHR or with access to redactedSOCRA SOURCE © November 202473
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