WIXLIB

Innovative Clinical Development Solutions

Study Conduct Medical CodingNovember 9, 2017

IntroductionPROMETRIKA Rave Coder PlatformAccreditation March 2017Medidata Coder Implementation ExperiencePROMETRIKA Medidata Coder Implementation ManualCreationRave Coder Advantages3

Coder vs. Vendor Stand Alone CoderMaps verbatim terms from AdverseEvents, Concomitant Medications andMedical History to specific terms inindustry standard dictionaries (i.e.,MedDRA, WhoDrug). Integrated withMedidata Rave EDC. Directtransmission between Coder and RaveEDC.4In contrast, other coder productsare built independently andexternally from the EDC and thenthe data is integrated in asecondary process.

Advantages of Medidata CoderThe Coder applicationincludes a number ofconfigurable parameters fordefining the applicationroles, coding workflow, anddictionary and synonym listmanagement5The integration allows forreal time auto-coding,manual coding, creation ofsynonyms, posting queriesdirectly to the site,reclassify a term (recode),perform coding consistencyreview and generate codingconsistency listingsCoding consistency reviewcan be performed on anongoing basis that allowsfor faster review andfeedback about codingassignments

Coder Configurable Parameters Manual provides procedural steps for implementingCoder through UAT Coder and application roles Coder segment, dictionary management (Licensure)and Coder workflow Set up coder segment Set up of dictionary versions to be used How terms are coded Synonym list management6 Creation and management

Integration of Rave and CoderTermentered bysite in RaveCodingconsistencylisting andreviewTerm codedin Coder perworkflowCodingassignmentreturned toRave7

Termentered bysite in Rave

Term codedin Coder perworkflowStudyStudy

Codingassignmentreturned toRave

Codingconsistencylisting andreview

Real Time Coding Auto-coding Direct dictionary match Synonym list match Manual coding Create synonyms Auto coding hit rate increases when more synonyms are in thesynonym list12 Post coding queries to the site to clarify verbatims Reclassify a term (re-code) Run coding consistency listings

Coding Consistency Review Performed on a ongoing basisFaster feedback about coding assignmentsSponsors see codes in Rave with read-only roleSynonym approval: First step of quality control forreview of coding “Activate synonym” before term can be used for auto-coding Lists created & used for auto-coding verbatims without a directdictionary match Can be retired at any time during the coding process13

Real Time Review 14Internal reviewSponsor reviewMedical Monitor reviewSafety Review meetingsData Monitoring Committee meetings

Coding Listings & Reports Custom coding consistency listings created Reviewers only see coding assignment information Other coding reports available 15Metric reports - number of coded termsCoding completion - all terms codedSynonym list approvalsReclassification complete

In SummaryIntegrationwith tencyreview

PROMETRIKA “NEXT” Adding Coder to an existing study Previous coding performed in dsNavigator Uploading synonym lists created from dsNavigator export files Planned for end of 2017 Dictionary up-versioning Implement external verbatim management (theMedidata stand alone Coder) for use on NDAsubmissions where up-versioning is required17

Questions

Medidata Rave EDC. Direct transmission between Coder and Rave EDC. In contrast, other coder products are built independently and externally from the EDC and then the data is integrated in a secondary process. Coder vs. Vendor Stand Alone Coder. 5 Advantages of Medidata Coder . The Coder application .