MCC

MCC: Site Quality Performance Metrics v1.0 At-­A-­Glance

Issue link: https://www.wcgclinical.com/insights/i/1083555

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www.metricschampion.org MCC SiteQuality P erformanceMetrics Version1.0 At A Glance INTRODUCTION BeginningFebruary2014,theMCClaunchedaninitiativetofocusonacriticalareaofconcernof MCCmemberorganizations howtoassessandmanagethequalityofclinicaltrialdesign, executionandoversight.TheMCCmadethereviewandrevisionofqua litymetricsatoppriority toensurethatorganizationsaremeasuringthe rightmetrics toimprovethequalityofclinical trials.TheMCCbroughtinindustrysubjectmatterexpertstoleadthethreeworkinggroupsin thisinitiative – theProtocolQualit yWG,theSiteQualityWGandtheComplianceQualityWG. TheSiteQualityMetricsWorkingGroup,comprisedofsponsorandCROrepresentatives, identifiedfivehighprioritysitequalityquestionsthattheywishedtoanswerthroughthereview ofperformanc emetrics: • Aresitesenrollingandretainingasufficientnumberofsubjects? • Aresitesdeliveringhighquality,evaluabledata? • AresitescompliantwithSAEreportingrequirements? • IsdatabeinggeneratedunderappropriateGCPandprotocolrequirements? • DoallclinicalresearchstaffhavedocumentedevidenceofsuccessfulcompletionofGCP &protocol specifictraining? ThesequestionsweregroupedintothefourkeyareasdepictedinExhibit1: Exhibit1:FourKeyAspectsofSiteQuality

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