looking to the future: medidata rave

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  • LOOKING TO THE FUTURE: MEDIDATA RAVELaura SmithP1115 TrainingNovember 2015

  • AGENDA

    Background System Features Data Collection Screens Transition

    2

  • WHAT IS A CTDMS?

    CTDMS = Clinical Trials Data Management System Web-based solutions for managing clinical trials data One location for managing data

    o Enter and view datao View data collection screenso Perform quality assurance o Respond to data discrepancies/querieso Generate various site reports

    There are numerous CTDMS on the marketo Medidata Rave was selected for the ACTG and IMPAACT networks

    3

  • WHY ARE THE ACTG AND IMPAACT NETWORKS TRANSITIONING TO A CTDMS?

    Computing technology is rapidly changingo A large company with many diverse clients can

    support such a systemo Ability to add many new and enhanced features

    The Statistical Data Management Center (SDMC) does not have the resources to develop existing systems to that extent over the long term

    4

  • WHY TRANSITION? (CONTD)

    Implementation of a CTDMS will allow us to meet the needs of the network in the future as data evolves

    CTDMS are compatible with CDISC standardso Required as part of the last grant recompetition for

    both the ACTG and IMPAACT networks

    5

  • WHAT IS CDISC?

    Outside organization:o Streamline data collectiono Facilitate data sharing and data exchange

    DAIDS-mandated FDA will require CDISC for future submissions

    CDISC = Clinical Data Interchange Standards Consortium

  • WHY WAS MEDIDATA RAVE SELECTED?

    Vendor experienced with large NIH-sponsored clinical trials

    FSTRF has experience with Rave in non-ACTG & IMPAACT projects

    Large company, founded in 1999 with numerous, diverse clients

    Met CDISC reporting requirements Best met other requirements

    o Supports coding and monitoring features

    7

  • WHAT DOES MEDIDATA RAVE LOOK LIKE? Homepage:

    o Enrollments to a studyo Task Summary

  • SUBJECT HOME PAGE Subject homepage displays expected visit schedule

    o Folder in left panel contains required forms for that visit

    Links in task summary will take you to the issue

    9

  • TRIGGERING A QUERY Queries appear in data collection screen

    upon saving

    10

  • MODIFIED DATA Yellow delta shows that the data were changed Query disappears but can still be tracked in the audit trail

  • EXPLANATION OF CORRECT DATA Add reason data are correct directly in data collection screen

  • STICKY NOTES AND COMMENTS Sticky notes and comments alert you to a new data collection

    screen or additional question without triggering a query Dynamic data collection screen or question added based on

    participants data

  • SUBJECT ENROLLMENT SYSTEM

    Sites will continue to use the subject enrollment system for all enrollmentso This process is not changing

    Enrollments will appear in Medidata Rave after a short periodo At that time, visits and data

    collection screens will be available to sites for data entry 14

  • LABORATORY DATA MANAGEMENT SYSTEM (LDMS)

    Use of the LDMS will continueo However, they are moving to a web-based LDMSo Visit the LDMS Demo Room for more information

    15

  • DATA COLLECTION SCREENS AND PRINTING Data collection screens will be available electronically

    o Created directly in Medidata Raveo Differ from the case reports forms sites have used in past

    Most data collection screens will be available in Medidata Raveo Forms will no longer be printed and shipped to siteso However, some participants questionnaires will only be available

    on DMC Portal for sites to print

    Sites may want to consider going to a direct data entry model 16

  • PRINTING: PDF EXAMPLE OUTPUT

    17

  • GRADUAL TRANSITION

    SDMC will work with network leadership to determine which studies will use Medidata Rave

    Both existing systems and new CTDMS will be in place for 2-3 yearso Most studies in progress will continue to use existing systems

    o Transition of long-term studies will be decided on a case by case basis

    o New studies will be developed directly in Rave

    Communication with sites will be important in this process 18

  • INITIAL STUDIES PLANNED FOR MEDIDATA RAVE

    New StudiesA5350A5352s

    Existing Studies to be MigratedA5322P1115

    19

  • SITE TRAINING The SDMC is in the initial stages

    of Rave configuration Site training is being planned

    and will be announced as it develops

    eLearning modules are available within Medidata Rave

    20

  • SUMMARY: CHANGE TO MEDIDATA RAVE CTDMS There will be changes in data collection System will allow for new features:

    o Web-based system with real-time changeso Streamlined data entryo Visit-specific folders contain required data collection screenso New reports and possibilities for quality assurance

    Transition will be gradual Case report forms will no longer be printed and shipped to the

    DMCo They will be replaced by data collection screens available for

    viewing and printing within Medidata Rave Will require changes for networks, DAIDS, study teams, SDMC,

    sites, and monitors in how data is managed 21

  • MORE INFORMATION?

    Contact dmc.medidatarave.support@fstrf.orgwith questions or comments.

    22

  • QUESTIONS AND COMMENTS?

    23

    Looking to the future: Medidata RaveAgendaWhat is a CTDMS?Why are the ACTG and IMPAACT Networks transitioning to a CTDMS?Why Transition? (Contd)What is CDISC?Why was Medidata Rave selected?What does Medidata Rave look like?Subject Home pageTriggering a queryModified dataExplanation of correct dataSticky Notes and CommentsSubject enrollment SystemLaboratory Data Management System (LDMS)Data Collection Screens and printingPrinting: PDF Example outputGradual TransitionInitial Studies planned for Medidata RaveSite TrainingSummary: Change to Medidata Rave CTDMSMore information?Questions and comments?

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