Boston Area CDISC User Network 20 July Melissa Cook Octagon Research Solutions

Transcription

1 Boston Area CDISC User Network 20 July 2011 Melissa Cook Octagon Research Solutions 1

2 CDISC SHARE Vision Background Content Development Project Plan Where we are today Next Steps Acknowledgements 2

3 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. 3

4 Background: The World Today CDISC Standards now encompass the entire drug development process protocol, collection, analysis, submission, controlled terminology, but there is more to be done. some elements don t fit in existing standards standards are not completely aligned or linked standards development takes time Paper/pdf orientated 4

5 Why do we need better metadata? To enhance Data Quality and Compliance To decrease the time taken to aggregate and review results Machine readable standards can lead to better enforcement Illustrate inherent relationships between metadata Speed up standards development 5

6 Compliance Issues Slide By: Ellen Pinnow, MS Health Programs Coordinator FDA, Office of Women s Health, Slide from 2006 CDISC US Interchange 6

7 Current 2D World Relationship Relationship Relationship 7

8 CDISC SHARE Aims To: Provide an environment within which existing content is easily maintained Accelerate new clinical research content development Encourage the widest possible participation in the development of new clinical research content (asynchronous contribution, 24/7) Deliver all of CDISC s existing and all new content in both human and machine readable forms Enable better automated handling of clinical research data through the use of machine readable content Assist in enabling the use of healthcare data in clinical research 8

9 How do we achieve this? Focus on developing rigorous & unambiguous definitions (semantic interoperability) Build scientific concepts on BRIDG Link all CDISC Standards: Controlled terminology SDTM variables CDASH variables Etc. 9

10 10 CDASH One Definition SDTM

11 Scientific Concepts which model? 11

12 BRIDG A domain analysis information model representing protocol driven biomedical/clinical research Provides a basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare. ISO compliant, HL7 alignment, RIM alignment 12

13 Scientific Concept Mind Map BRIDG Classes Data types SDTM Variables CDASH Variables Controlled Terminology 13

14 CDISC Share Phase 1 Content The Challenge: Moving to the new, scientific concept based view of the world where BRIDG is the semantic foundation, from SDTM and CDASH as we know them today 18 month effort so far Beginning with what we know now SDTM, CDASH, Controlled Terminology, and BRIDG 14

15 CDISC Share Phase 1 Content Last year: Content team aligned SDTM and CDASH definitions, and aligned them with BRIDG Question Text Prompt SDTM or CDASH Variable Name BRIDG Definition CRF Completion Instructions Information for Sponsors Core At what location was the measurement taken? Locatio n VSLOC PerformedObserv ation Result.targetAnat omic SiteCode Location relevant to the collection of Vital Signs measurement. Example: LEFT ARM for blood pressure. {LOC) (See Section 2.2) Record or select location on body where measurement was performed, if not pre-printed on CRF. Location may be pre-defined as part of CRF label. O Variable Name Variable Label Type Contro lled Terms, Codeli st or Format Role CDISC Notes Core Referen ce VSLOC Location of Vital Signs Measurement Char (LOC) Record Qualifi er Location relevant to the collection of Vital Signs measurement. Example: LEFT ARM for blood pressure. Perm SDTM

16 Content Mapping 16

17 Protection of the Content SDTM ADaM CDASH View View View View SHARE Scientific Concepts (BRIDG, Terminology, Data Types...) BRIDG XML V3 Message(s) XML Format(s) Tabular Form Slide Dave Iberson Hurst 17

18 Summary Richer content Machine readable Layered / structured One definition used many times Structured using BRIDG constructs to reflect the nature of the data Evolution of where we are today 18

19 Project Plan 19

20 Where We Are Today 20

21 CDISC Share Phase 1 Content Content team to map metadata into model based Spreadsheets that include: All SDTM CDASH domains BRIDG Controlled terminology Data types 21

22 CDISC Share Phase 1 Governance Basic governance in place through mapping of simple scenarios Basic administrative and participant roles defined 22

23 Governance Use Cases Under Development 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 23

24 CDISC Share Phase 1 Key Functionality Requirements Users should be able to import & export content. Users should be able manipulate data. Users should be able access an electronic equivalent of a subset in PDF of SDTMIGv3.1.2, CDASH v 1.1, Terminology. Export a Word equivalent. 24

25 Model Development MD Model High Level Project Plan Model Team Content Content Team Study Construction Concepts Lab Team Governance & User Interface Governance Team User Interface Team Software Requirements Software R1 25

26 Longer Term CDISC Share Development Plan Major Development 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 Continuous smaller increments in content Phase 4 Phase 5 ADaM and new TA new TA 26

27 CDISC Share Conclusion Precise definitions Rich metadata 24/7 access Linked to NCIt Terminology Resources Links Clinical Research to Healthcare 27

28 Active Participants CDISC acknowledges all volunteers, their affiliated companies and the NCI-EVS for support of the CDISC Share project. 28

29 Questions about CDISC Share? Interested in joining a team? Contact Rhonda Facile (NCI EVS) rfacile@cdisc.org Rhonda.Y.Facile@mail.nih.gov Or visit: cdisc.org 29

30 Questions? Presentation courtesy of Rhonda Facile and the efforts of the CDISC Share Team Thank you! Melissa Cook 30

31 Strength through collaboration....and sharing As a catalyst for productive collaboration, CDISC brings together individuals spanning the healthcare continuum to develop global, open, consensus-based medical research data standards. 31