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Forms Development and RAVEShauna Hillman, MSMayo-Rochester, MNMay 11th, 2017

Presentation ObjectivesllllProvide the Alliance high level process fordeveloping forms (both paper and electronic)Provide a basic understanding for how the DataCapture System (Medidata Rave) functionsProvide key elements in successful data collectionProvide key elements in efficient Rave builds

Forms Development ProcesslBegins with a stable Protocol (draft #3)llllllSchemaEligibility CriteriaRegistration/RandomizationTreatmentDisease EvaluationStudy Calendar

Forms Development ProcesslStudy Developer (SD) selects the appropriate paperCRF templates, and creates any study specificforms based on review of the protocollllllEligibility ChecklistOn-Study FormTreatment FormAE FormPatient Status FormlllOff TreatmentWithdrawal of consentLost to follow-upNew PrimaryTreatment indicatorDisease/vital statusIndicators for the rollout of additional forms

Forms Development ProcesslStudy team reviews the initial draft, answers SD questions andprovides feedback to ensure the CRF content is consistent with theprotocol endpoints and meets data collection needslStudy Team MemberslllllllllPI: Principal InvestigatorStat: StatisticianSPA: Statistical Programmer AnalystDM: Data ManagerPC: Protocol CoordinatorSD updates the pCRFs based on study team feedbackStudy team provides final approval (documented via the Statistician)Forms sent for curation (check that NCI standards are being used)pCRFs are frozen and eCRF build begins

eCRF DevelopmentlAlliance Navigation PhilosophyllAdd folders one visit/cycle at a time based ondata entered for the current visit/cycleFive phases of data collectionlllllBaselineTreatmentOff TreatmentClinical Follow-up: more rigorous data collection,typically collecting AE and Measurement dataSurvival Follow-up: less rigorous data collection,primarily capturing late AE, progression, new primaryand vital status

General navigationBaselineTreatment(repeat as needed)Off TreatmentClinical Follow Up(repeat as needed)Survival and Disease StatusFollow Up(repeat as needed)

eCRF DevelopmentlPatient Pathway Diagram (PPD)llStudy team communication tool and specificationsused for database designVisual picture of patient pathways for data submissionllIncludes all pathways not just the expected pathNecessary for:llFolder and form roll-outTracking (folder target and overdue dates)

eCRF DevelopmentlForms TrackinglTarget dates are set indicating when forms withinthe folder are expected based on data entry andtrial requirements.lThe timeframes* for designating forms overdue§§§Baseline: 15 days from target dateTreatment: 15 days from target dateFollow-up: 30 days from target date*NCI Standards for NCTN trials

Display of Folders in RaveExample of Rave subject homepageList of all foldersVisit folders withcalendaring trackingActual visitsdates basedon dataentryTarget Dates

eCRF DevlopmentStudy Build Team & ProcessHigh Level Process for Developing a Trial in RavePlanningBuildingTasksProject Planning:request projectsetup, identifytimelines andteam membersRequirementsGathering:includes pCRFreview, PPD, andDSS developmentBuild/Copy/Install and Validate, testUnit Test: eCRFs,and verify thereusable edit checks buildand customfunctions, and studyspecific datavalidationsActivation of trialin Rave includingRave readinesssignoffStudy TeamPI, Stat, SPA, DMPC, CRA*Stat, SPA, DMStat, SPA, DM,DMS, CMStat, SPA, PC,DMRave BuildTeamSDSDSDSD*optional membersTestingProduction

Rave Feature: Role Specific TaskSummaryData ManagerRoleSite role

Rave Feature: Full Audit TrailMost current events areon the topUser responsible foreventDate andtime of event

Rave Feature: FormsTrackinglOverdue forms are displayed in the Rave TaskSummary by the clock iconllAll target and overdue data is configurable at the studylevelExpected and overdue material (forms & queries)reports available to sites on Alliance website

Rave Feature: Forms TrackinglExample Overdue Material Report

Rave FeatureQuerieslRave allows for both system-generated andmanual-generated queriesllSystem-generated queries fire at the time a formis saved (system field edits and configurableedits)Manual queries are created by selected roles andcan be done at any timellData ManagerCentral Monitor

Rave FeatureQuerieslAnswering QuerieslSites can respond to queries by:lModifying the data in the fieldlProvide an explanation in the user response box (freetext) if data cannot be entered

Database DesignQueriesSite gets immediate feedback (upon form save)

Clinical Reviews Facilitated inRavelEligibility ReviewslThe DM will be flagged for eligibility review when all study identified formsare entered by the siteFor example:lllllllOn-studyRadiographic Imaging Assessment: BaselineSupporting Documentation: BaselinePatient Status: BaselineThe DM completes the eligibility reviewDM notifies Study Chair in the case of questionable or ineligible patientsvia checkbox on the eligibility form and upload the necessary reportsStudy Chair will review via RavelIf there is a disagreement, the DM is notified for arbitration

Eligibility Review FormCompleted by the Study Chair

Clinical Review Facilitated inRavelCase Evaluation (endpoint) ReviewlMedical review of key clinical data conducted when apatient meets the primary study endpoint (studydefined):For examplel Progressionl Death without progressionl Follow-up completed without events abovel Withdraw consent for all follow-up without events abovel Confirmed lost to follow-up without events above

Clinical Review Facilitated inRavelCase Evaluation Processl Data Manger (DM) is flagged to review within Ravel DM reviews data submitted for completeness & accuracyl DM runs the endpoint review report and attaches it to a form within Ravel DM sends cases to the Study Chair (SC) in Rave following AlliancePolicylllSC is flagged to their review via an e-mail and querySC reviews data in Patient Summary Report and completes the CaseEvaluation form (in Rave)lllFirst 100 pts, every 10 thereafter up to 300 and any problem casesSC will have access to CRFs for Phase I or II trialsSC will not have access to CRFs for Phase III trialsDM reviews discrepancies or other problems noted by the SC andqueries the site, if necessarylIf there is a disagreement, the DM is notified for arbitration

Case Evaluation FormCompleted by the Study Chair

Keys Elements of SuccessfulData CollectionlLess is morellllData collection is costlyCollecting unnecessary data takes time andresources away from critical data elementsAll data collected should be linked to a study aimThe number of solicited Adverse Events includedsignificantly increases data collection and datamanagement time. It also decreases theresponse time in Rave. Target 10 wheneverpossible

AE Example

AE ExampleDynamic grade dropdown that only displaysgrades appropriate forthe selected AE term

Key Elements of SuccessfulData CollectionlCase Report Forms are CriticalllA lot of resources goes into developing theprotocol, if the same level of effort is not put intothe design of the case report forms, trialobjectives will not be metStudy Chair involvement is CrucialllSD are not disease or study experts, they needyour input and reviewIt takes considerable resources to make changesafter protocol activation (avoid migrations)

Key Elements of Efficient RaveBuildslUse the Standards whenever possiblellllReduces build and testing timeReduces curation timeFacilitates standardized outputs and reportingReduces data entry errors with familiarity of eCRFdesign by end users


Rave Feature Queries lRave allows for both system-generated and manual-generated queries l System-generated queries fire at the time a form is saved (system field edits and configurable edits) l Manual queries are created by selected roles and can be done at any time l Data Manager l Central Monitor

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