Medidata Rave and IWRS/OPEN — Early Drug Development ...

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  • Medidata Rave and IWRS/OPEN

    Early Drug Development MeetingApril 21 2013April 21, 2013

    1

  • Medidata Rave and IWRS/OPEN

    AgendaAgendaRegistrationSl iSlotReservationsCohortManagementMedidata RaveData Submission GuidelinesDataSubmissionGuidelinesTechnicalSupport

    2

  • Example Registration Flow

    RegistrarLogsintoOPEN

    ChooseEnroll

    If last Slot taken, IWRS Notifies Sites of Closed

    Cohorthttps://open.ctsu.org

    Selectsite,protocol,investigator

    TheradexIWRS Cohort Management

    OPEN Verifies Slot Available and Cohort Open

    Cohort

    investigator

    Enterdemographicandeligibilitychecklistdata

    Management System

    IWRS Marks Slot as Takeng y

    Review&SubmitEnrollment Results:

    as TakenLegendOPEN

    IWRS

    TheradexIWRS Registration

    System

    EnrollmentResults:PatientID

    &TreatmentArm

    3

    System

    eCRFs

    MedidataRave

    Enrollment eCRFs

    IWRS Populates Rave eCRFs

  • Example Theradex IWRS Slot Reservation Flow

    R i t Cli k Ch Sl tRegistrarClicksIWRSlinkinCTSUwebsite

    https://iwrs theradex com

    Choose Slot Reservation

    https://iwrs.theradex.comSelectsite,

    protocol,cohort

    ClickReserve

    IWRS Marks Slot

    LegendCTSU.org

    IWRSIWRSMarksSlot

    asReserved

    OptionalFeatures:

    4

    SlotReservationApprovals RemindersofUnusedReservations

  • Example Theradex IWRS Cohort Management Flow

    L d I tit ti Ch C h t

    g

    LeadInstitutionClicksIWRSlinkinCTSUwebsite

    https://iwrs theradex com

    Choose Cohort Management

    https://iwrs.theradex.comSelectprotocol

    Open,Close,orExpandCohorts

    LegendCTSU.org

    IWRS

    IWRSnotifiesSitesofCohortchange

    5

  • Quick and Easy Cohort Managementg

    Open and Close Cohorts

    InstantEmailNotificationstoSites

    Reserve Slots

    6

  • Medidata Rave

    Web based EDC (electronic data collection) to be used in Web based EDC (electronic data collection) to be used in all future NCI studies

    All ET-CTN studies will use the same standard TheradexAll ET CTN studies will use the same standard TheradexeCRFs resulting in expedited study set-up following approvalpp

    Built-in, Real-time Edit Checks will minimize queries and after-the-fact data cleaning

    Queries entered by CTMS monitors and auditors can be resolved within Rave by the site staff

    7

  • Medidata Rave Screenshot

    8

  • Data Submission Guidelines

    All data is to be submitted within 2 weeks from when it All data is to be submitted within 2 weeks from when it becomes available to the site

    Queries should be answered within 2 weeks of being Queries should be answered within 2 weeks of being issued

    Task Summary makes it easy to track what tasks are Task Summary makes it easy to track what tasks are pending (e.g. non-conformant data, open queries, overdue data, etc.) for a study or a patient.

    9

  • End of Study Report

    Theradex will create End of Study Report within 60 days Theradex will create End of Study Report within 60 days of last patient completing

    End of Study Report will be used for Statistical analysis End of Study Report will be used for Statistical analysis, and have a sub-report with a subset of data.

    Summary Reports for FDAAA Applicable Clinical Trials Summary Reports for FDAAA Applicable Clinical Trials (ACT)

    10

  • Technical Support

    Theradex provides Rave User GuideTheradex provides Rave User GuideTheradex will provide support for IWRS and RaveCTSU will provide support for RSS and OPENCTSU will provide support for RSS and OPEN

    11

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