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CDMS Face-to-Face Meeting

CDMS Face-to-Face Meeting. Medidata Rave David Geismar Client Services Principal August 3, 2010. Agenda. Rave Overview Medidata Support, Services and Training Legacy Data Migration. Rave Overview. Rave Overview. Rave Modules - EDC.

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CDMS Face-to-Face Meeting

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  1. CDMS Face-to-Face Meeting Medidata Rave David Geismar Client Services Principal August 3, 2010

  2. Agenda • Rave Overview • Medidata Support, Services and Training • Legacy Data Migration

  3. Rave Overview

  4. Rave Overview

  5. Rave Modules - EDC • Primary module for End-User data entry and data management for trials • User roles and workflow are configurable according to customer requirements • One user account can have access across multiple trials with different roles • Task or Subject based navigation • Intuitive user interface

  6. Rave Modules - EDC

  7. Rave Modules - Architect • Web-based study design and configuration tool • Self-documenting system • Primary module for initial eCRF and Data Validation Configuration • Configuration privileges are role dependent (i.e., Study Developer I has eCRF design only) • Mid-study changes are managed within the Architect module via Amendment Manager

  8. Rave Modules - Architect

  9. Rave Modules - Global Library • A tool that facilitates the process of reusing study components to make study building a more efficient process • A repository that houses architect objects according to user-defined volumes • Consists of a library copy wizard which allows users to quickly and efficiently select objects stored in the Library, or other Architect projects, and copy those objects into project drafts • Can be used for: • Therapeutic areas • caDSR standards • Reusing forms and other objects

  10. Rave Modules - User Administration • Enables system administrators to manage User accounts: • Create and maintain Rave users • Associate users with studies and/or sites • Indicate sponsor approval and training dates • Provide access to Rave modules

  11. Rave Modules - Site Administration • Enables system administrators to manage site records: • Create and maintain Sites • Create and maintain Site Groups • Associate sites with studies • Associate Investigators with study sites

  12. Rave Modules - Rave Reporter • 30+standard reports with Rave Application: • Formatted reports • Data streaming reports • JReview allows users to browse and create reports on the clinical data

  13. Rave Modules - Rave Reporter

  14. Rave Modules - Rave Report Administration • Administration facilities to: • Assign reports to users and/or EDC roles • Assign reports to appear at study, site or subject level • Determined on a per study basis • Add new custom reports to list of available reports • Add custom parameters to allow prompting of metadata specific conditions

  15. Rave Modules - Core Configuration • Global configuration settings for all projects • Defines the clinical workflow • Defines the Graphical User Interface (GUI) Settings • Defines security model for Rave

  16. Rave Modules - Core Configuration • Settings • Change Codes • Subject Status • Field Edit Checks • Deviations • User Groups • Advanced Configuration • Workflow • Review groups • Marking groups • EDC Roles • Messages • User Interface • Colors • Fonts

  17. Rave Modules - Core Configuration • Allows for customization of various system-wide settings: • Password and login requirements • Change codes • Subject status • Field edit checks • Deviations • User Groups • Advanced Configuration

  18. Rave Modules - Architect Security • Used to control user access to projects and Global Library volumes (GLV) within Architect • Users are assigned to Security Roles • Actions they can take on a project or GLV • Able to associate Security Roles with Security Groups

  19. Architect All Projects Create Project Inactivate Projects Push to Aux Push to Production Global Library Read Update Publish Define Copy Sources Upload/Download Draft Create Security Groups Security Role Security Role Rave Modules - Architect Security

  20. Rave Modules – Lab Administration • Rave can accommodate both Central and Local Laboratory data • Central Lab data can be loaded using Batch Loader or Rave Web Services and stored in eCRFs • Local Lab data can be entered by sites • Analytes, Units, Unit Dictionaries, Reference Ranges, Alert Ranges, Clinical Significance administered within a central module

  21. Rave Modules - Double Data Entry • Keyboard-friendly user interface helps speed data entry • DDE may be flagged for sites • DDE can also be flagged for individual forms • First pass -> Second pass -> Reconciliation • Differences between first pass and second pass data are automatically flagged for reconciliation • Data does not appear in EDC until it has gone through DDE • Query Resolution Worksheet or Data Clarification Forms

  22. Rave Modules - Translation Workbench • Gives the user the ability to translate strings for a locale • Localization allows one study to be displayed in multiple languages with minimal effort • Localization handles languages that use double byte characters, such as Chinese and Japanese • The Japanese and English locales are available with the Rave installation • Locale-specific Help files can be used • A ‘default’ locale can be set for a URL, but individual Locales are assigned at the user level

  23. Rave Modules - PDF Generator • Provides users with the ability to produce PDF files that are submission-ready for regulatory authorities and archiving at clinical sites • Users can create blank PDFs for IRB or Ethics Committee submission based on eCRF Version • The PDF format(s) are configurable and can be predefined and stored in Rave Configuration • Users can schedule PDFs and provide file paths for retention • PDFs files are localizable

  24. Rave Modules - Query Management • A tool to manage queries for the EDC and DCF modules • Can search for queries across the entire Study and perform batch actions on the results • Actions include: • Forwarding queries • Answering queries • Closing queries • Canceling queries • Must have the correct permissions to access the Query Management module

  25. Rave Overview – Workflow caDSR Patient Registration Clinical Connector Lab Data Rave Global Library Rave Architect Study Rave EDC Study Theradex/ CDUS Rave DTE

  26. Medidata Services

  27. Medidata Services IT Hosting Professional Services Support Services -24/7/365 Help Desk Medidata University -In-Person Training -Webinars -eLearning Global Consulting Services -Knowledge -Process-Technology Implementation Services -Knowledge Transfer -Custom Integrations -Study Build

  28. What is Knowledge Transfer Knowledge Transfer (KT) is the process by which Medidata provides services, consulting, resources, knowledge, process expertise, technology and tools to enable clients(or third parties) to take ownership of how they implement, administer and utilize Medidata products for their own organizational strategy. KT provides organizations the ability to become autonomous in their use of Medidata products so that they can derive maximum benefit, control and value from their investment

  29. Knowledge Transfer – Strategy example Client • Scope • Planning • Initial Training • Architecture • Hosting • Process • Procedures • Documentation • Core Config • Change Mgt. • CSFs • KPIs • Op. Support • Mentorship Piloting / Simulation Primary KT Components All KT Components Autonomy Operational Support Level of Involvement Mentorship Medidata KT Adoption Timeline Medidata involvement decreases as you move through the phases of KT Implementation

  30. CTEP Deployment “Ops Center” Program Management Team Rave Mentorship Team Group/Site Implementation Team Group/Site Implementation Team Group/Site Implementation Team Group/Site Implementation Team

  31. Organizational Structure • Ops Center • Central point of contact for CTEP Rave implementation • Consists of Program Management Team and Rave Mentorship Team

  32. Organizational Structure • Program Management Team • Responsibilities: • Central management of the CTEP CDMS implementation • Manage relationship and expectations for Rave implementation and Knowledge Transfer • Development of program documentation • Evaluation of integration requests for CTEP Rave implementations • Oversight and coordination of all overlapping project timelines and priorities for CTEP

  33. Organizational Structure • Program Management Team • Deliverables: • CTEP Rollout Plan • KT Program Plan • Knowledge Transfer Approach • Operational Support Plan • Communication Plan • All Program level documentation • Staffing: • Medidata CSP/PD • Medidata Project Manager • CTEP designated Project Manager(s)

  34. Organizational Structure • Rave Mentorship Team • Responsibilities: • Study build and operational support • Knowledge Transfer and mentorship for CTEP-designated Rave support personnel • Development of the Rave support model • Deliverables: • Mentorship Plan • Staffing: • Medidata Project Analyst • Medidata Technical Consultant(s) • CTEP-designated Rave support personnel

  35. Organizational Structure • Group/Site Implementation Team • Responsibilities: • Rave training for the appropriate track • Installation of Rave instance (for self-hosting) • Deliverables: • Functional Rave instance • Installed Rave eLearning • Rave Training Plan • Appropriate certification documentation

  36. Support • Medidata provides 24/7/365 Support Services • Tier 1 – General usage issues, account lock-outs, etc. • Tier 2 – Configuration issues, advanced user support • Tier 3 – Application or Infrastructure/Hosting support • Operational Support Plan for NCI/CTEP is still to be defined

  37. Support Services Study & User Support: Resource Requirements Helpdesk - Internal vs. Vendor based Numbers of Studies/ Sites/ Users (Internal/External) influence demand on helpdesk support Roles and Responsibilities T1-T3 Helpdesk Support Internal Account Management for Study Build activities All External End User Account Management processes for each specific Rave modules Report Administration Triage of technical support vs. clinical study specific Recording and tracking Helpdesk support requirements Study Design, Study Build and Maintenance Support (e.g. application support)

  38. Training • Training is provided on an individual course basis • For the CTEP implementation, training has been organized into Rave knowledge level consisting of individual training tracks • Medidata will provide training via webinar or onsite as appropriate • General thumb rule is 10 attendees for a training session, 5 attendees for a workshop

  39. Implementation Training Levels • Rave Ready • Provide basic Rave services, site and user administration, end user training and basic reporting and closeout activities. •  Rave Accredited • Build and configure their customers Rave studies. • Study build services, in addition to end user training, administration and reporting services. • Rave Accredited Plus • Full suite of Rave-related services, including end user training, study build, reporting, outputs, integrations and migrations.

  40. Implementation Level Rave Ready • Rave Ready consists of the following tracks: • Track # 1 – Rave Fundamentals • Track # 2 – Rave EDC Study Management • Track # 3 – Rave Administration • Track # 4 – Rave Configuration • Track # 5 – Rave Basic Reporting

  41. Implementation Level Rave Accredited • Rave Accredited consists of the following tracks: • Rave Ready (Track 1-5) • Track # 6 – Study Build • Track # 7 – Study Design Standards and Global Library

  42. Implementation Level Rave Accredited Plus • Rave Accredited Plus consists of the following tracks: • Rave Ready (Track 1-5) • Rave Accredited (Track 6-7) • Track # 8 – Study Design Build Essentials Train the Trainer (SDBE TTT) • Track # 9 – Lab Data and Integrations • Track # 10 – Rave Advanced Development • Track # 11 – Rave Double Data Entry (DDE) • Track # 12 – Rave Advanced Reporting • Track # 13 – Amendments / eCRF Migrations

  43. Legacy Data Migration

  44. Legacy Data Migration • Data migration is highly dependent on: • Format of data • SAS, ASCII, ODM • Type of data • Clinical Data, Markings/Queries, Status, Audits • Rave provides two methods of importing legacy data: • Rave Web Services (RWS) • Batch Uploader (BU)

  45. Legacy Data Migration – Rave Web Services • Utilizing Rave Web Services, you can import: • Metadata – Study design • Clinical data • Workflow status (Review, Verify, Lock and Freeze) • Translated values • Queries (Open, Answer, Cancel, Close and Forward) • Audit trail information • Coding information • In order to utilize RWS, data must be provided in ODM 1.3 XML standard format

  46. Legacy Data Migration – Batch Uploader • Utilizing Batch Uploader, you can import: • Clinical data • Open Queries • Batch Uploader requirements include: • Study must be built in Rave • Data must be provided in a per form basis • Data must be in ASCII or Excel format • Batch Uploader must be configured/mapped for each unique CRF

  47. Legacy Data Migration– Other Considerations • Reporting/verification/validation • Maturity of integrations – for ongoing trials • Retirement of legacy system

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