CDISC SHARE. Dave Iberson-Hurst Assero Limited CDISC E3C & SHARE Team Co-Lead

Transcription

1 CDISC SHARE Dave Iberson-Hurst Assero Limited CDISC E3C & SHARE Team Co-Lead

2 Outline An overview of the SHARE programme Why SHARE SHARE Programme (Moved to end) An explanation of the content of SHARE How SHARE will be governed How SHARE content can be used The CDISC EU Interchange in Brussels

3 Why SHARE

4 Compliance Issues Slide By: Ellen Pinnow, MS Health Programs Coordinator FDA, Office of Women s Health, Slide from 2006 CDISC US Interchange

5

6 Relationship Relationship Relationship

7 One Definition

8 Why do we need better metadata? To enhance Data Quality and Compliance To decrease the time taken to aggregate and review results Make machine readable standards which will make enforcement possible Illustrate inherent relationships between metadata Speed up standards development

9 CDISC SHARE VISION A global, accessible electronic library, which through advanced technology, enables precise and standardized data element definitions (and richer metadata) that can be used in applications and studies to improve biomedical research and its link with healthcare.

10 A global, accessible electronic library, which through advanced technology, enables precise and standardised data element definitions that can be used in applications and studies to improve biomedical research and its link with healthcare

11 Protocol Writing A global, accessible electronic library, which through advanced technology, enables precise and standardised data element definitions that can be used in applications and studies to improve biomedical research and its link with healthcare ecrf Design Institution Repository Data Aggregation Clinical Data Management Data Analysis

12 SHARE Content

13 Which Model?

14 Meta Data Model Standards Operational Collections Scientific Concepts Templates A standard is a collection of operational collections Operational Collections are the use of Scientific Concepts brought together to meet a business need (e.g. a domain) Templates then used to construct Scientific Concepts, representing the content within the CDISC standards, define once. BRIDG classes and relationships used to fashion small re-usable patterns BRIDG ISO data types Core building blocks come from the BRIDG DAM classes, attributes and associated data types (ISO 21090).

15 Meta data Model Standards Operational Collections Presentation & Business Needs ( Views ) Scientific Concepts Templates Content BRIDG ISO data types

16 Scientific Concept - Mind Map BRIDG Classes SDTM Variables CDASH Variables Controlled Terminology (NCIt)

17 Scientific Concept - Mind Map BRIDG Classes SDTM Variables CDASH Variables Controlled Terminology (NCIt)

18 Scientific Concept - Mind Map BRIDG Classes SDTM Variables CDASH Variables Controlled Terminology (NCIt)

19 Scientific Concept in Template Spreadsheet

20 Build on Existing Capability Access API etc SHARE Access FDA CDISC NIH HL7 Additional contexts NCIt Additional Contexts

21 Build on Existing Capability Powered by NCIt Access API etc SHARE Access FDA Expertise CDISC Context Expertise CDC Additional contexts NCIt Additional Contexts

22 Flexibility in using Content SDTM ADaM CDASH View View View View SHARE Scientific Concepts (BRIDG, Terminology, Data Types...) BRIDG NCIt XML V3 Message(s) XML Format(s) Tabular Form

23 Define Once, Use Many SDTM ADaM CDASH View View View View SHARE SC Scientific Concepts (BRIDG, Terminology, Data Types...) BRIDG NCIt XML V3 Message(s) XML Format(s) Tabular Form

24 Flexibility in using Content SDTM ADaM CDASH View View View View SHARE Scientific Concepts (BRIDG, Terminology, Data Types...) BRIDG NCIt XML V3 Message(s) XML Format(s) Tabular Form

25 SHARE Governance

26 Meta Data Model V V V V Standards Operational Collections Scientific Concepts Templates A standard is a collection of operational collections Operational Collections are the use of Scientific Concepts brought together to meet a business need (e.g. a domain) Templates then used to construct Scientific Concepts, representing the content within the CDISC standards, define once. BRIDG classes and relationships used to fashion small re-usable patterns BRIDG ISO data types Core building blocks come from the BRIDG DAM classes, attributes and associated data types (ISO 21090).

27 Work Flow Overview Request Work Item (WI) request could be anything from typo up to "please implement a new standard". The request could result in one or more Scientific Concepts, Code Lists etc being created or amended. Assessment The submitted Work Item is assessed by WI Lead and additional WI Assessors as required. The assessment includes the collection of further information being, if needed, and an impact analysis to ensure that no duplication/overlap with existing concepts. If agreed, the WI is approved for development or merging with other WIs (or splitting). If not, the submitter is notified of the decision to reject the WI. Development Work Item is now in development where the Managed Object life-cycle comes into play for each object being created or modified as part of the WI. Review Work Item has now been approved by the team and is now in public review. Each Managed Object is review either on its own or as a set. When all Managed Objects have been approved the Work item as a whole can be approved (closed) Approval Once approved the Work Item is considered finished (closed). Appeal At this stage the Work Item can be appealed if a reviewer feels strongly enough about a certain direction / decision that has been taken or made. The Work item is moved back to the review stage for re-assessment. Finished

28 Managed Object Life-Cycle Draft The Managed Object is created for the first time and worked on by a group of interested subject matter experts Review Once those working on the item are happy the Object can undergo formal review. Pre-Production When the review has passed the Object can be placed into the Pre-Production state. Production The Object can then be moved to the Production state and the Object is the current (latest) object for use by the community Frozen When changes are required the current version of the Object is Frozen, This allow this version to continue to be used by the community but indicates there is a newer version either being worked on or in production. Finished

29 Work Items and Managed Objects Work Item Request Work Draft Item Managed Objects Assessment Review Development Pre-Production Review Production Approval Frozen Finished Finished

30 Work Items and Managed Objects Work Item Request Assessment Managed Objects Development Review Approval Finished

31 Governance Work Item A simple addition to a code list Scientific Concept Code List Code List Item Work Item Addition of a Scientific Concept to a Domain Scientific Concept Scientific Scientific Concept Scientific Concept Concept Existing Domain Work Item New Domain Scientific Scientific Concept Scientific Concept Scientific Concept Concept New Domain

32 Using SHARE & EU Interchange Brussels

33 SHARE Next Steps End of Jan SDTM+CDASH moving forward 4 domains DM, VS, AE, CM + other domains Content Miracle Issues: Rules MDM Requirements Use Cases Gov-UG, SOP Training/Education/News R1 Regs MDM Use Guidance Doc Formats (download) Of delivery Working Groups NCI Software Key functionality: Users can import & export content. Users can manipulated data. Users can access an electronic equivalent of a subset in PDF of SDTM IG, CDASHIG, Terminology.

34 Plan Activity 2011 Content Jan Feb Mar Apr May Jun M Governance Use Issue Tracking Face-to-Face Meetings M M M M Events DIA/FDA CSC Meeting Euro Interchange DIA EuroMeeting HL7 WGM

35 Plan Activity 2011 Jan Feb Mar Apr May Jun Content Governance Use Issue Tracking M Friday, 15 th April SHARE F2F. Focused on using the system. Face-to-Face Meetings M M M M Events DIA/FDA CSC Meeting Euro Interchange DIA EuroMeeting HL7 WGM

36 SHARE Programme

37 Timeline /2007 to 4/2008 BoD Discussions 9/2008 to 4/2009 Focus & EU FP7 10/ Implementation 4/2008 to 9/2008 Early Thinking 4/2009 to 1/2010 Pilot

38 Timeline Content Content Alignment, Requirements and Metadata Model Governance System Use SHARE Phase 1 NCI Software

39 Major Phases SDTM CDASH Oncology, Devices, TA (current) Phase 1 SEND and new TA Phase 2 Phase 3 Phase 4 Phase 5 ADaM and new TA new TA

40 Major Phases SDTM CDASH Oncology, Devices, TA (current) Phase 1 SEND and new TA ADaM and new TA Phase 2 Phase 3 Continuous smaller increments in content Phase 4 Phase 5 new TA

41 Major Phases SDTM CDASH Oncology, Devices, TA (current) Phase 1 SEND and new TA Continuing SW Releases (do not need to be aligned with Phases) Phase 2 Phase 3 Phase 4 Phase 5 ADaM and new TA new TA

42 Active Participants Clyde Ulmer - FDA Erin Muhlbradt NCI-EVS Fred Wood - Octagon Gary Walker - Quintiles Hanming Tu - Octagon Madhavi Vemuri J & J Mary Lenzen - Octagon Melissa Cook - Octagon Mike Riben MD Anderson Diane Wold - GSK Simon Bishop - GSK Terry Hardin - Parexel Tsai Yiying - FDA Michael Morozewicz Shannen McGinnis - Amgen Barry Cohen - Octagon Dave Iberson-Hurst - Assero Rhonda Facile NCI-EVS Chris Tolk - CDISC Dianne Reeves NCI-CBIIT Barrie Nelson - Amgen Julie Evans - CDISC Jian Chen - Edetek

43 Summary

44 Summary Content A single definition used many times, explicit relationships, better definitions Governance More localised (smaller), more flexible standards development, faster Users Machine & human readable Greater flexibility and starting to grey the boundaries