CDISC Public Webinar SHARE Deep Dive and BRIDG Model Overview 20 OCT 2016

Transcription

1 CDISC Public Webinar SHARE Deep Dive and BRIDG Model Overview 20 OCT

2 Agenda SHARE Deep Dive Anthony Chow, Sr. Manager, Technical Development, CDISC BRIDG Model Overview Smita Hastak, Senior Analyst Samvit Solutions, LLC Dr. Lauren Becnel, Senior Director of Biomedical Informatics and Alliances, CDISC CDISC Online Education & Event Updates John Ezzell, CDISC 2

3 Question & Answer Panelist : Question OR Presentation : Question Examples: Smita: Where can I find the BRIDG model standard documentation? SHARE: Can you elaborate on future plans for the SHARE application? 3

4 CDISC Public Webinar : SHARE Deep Dive Anthony Chow Sr. Manager, Technical Development, SHARE CDISC 4

5 Topics Curation Process Components Applications of Metadata Use at CDISC 5

6 Curation Process In the context of CDISC COP Standards Development ( Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education Provide a walkthrough of the curation process at each development stage 6

7 Curation Process Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education With TA concept sourcing from member organizations, content/concept gap analysis: new vs. existing Concept modeling, such as mind maps, CRF examples, analysis methods 7

8 Curation Process Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education Establish metadata guidelines Definition, granularity, clarity, and relationship, etc. Constraints: Cardinality, value list, value subsetting Provide modeling expertise New metadata elements, metadata types Identify new metadata-driven standards development opportunity 8

9 Curation Process Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education Foundational Standards Review consistency and conventions Review metadata, e.g., variable labels, use of CDISC CT, dataset metadata, Provide/review diffs as a form of impact analysis TAUG All of the above Review all foundational standards mentioned, CDASH, SDTM, ADaM TA Specifications Membership at Standard Review Council Final quality review before a draft standards goes to Public Review 9

10 Curation Process Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education Address metadata-related issues reported Answer metadata-related questions from Public Review Membership at Standard Review Council Final quality review before a draft standards goes to Public Release 10

11 Curation Process Stage 0 Stage 1 Stage 2 Stage 3a Stage 3b Stage 3c Stage 4 Scoping & Planning Identification/ Modeling of Research Concepts Development of Draft Standards Internal Review Public Review Public Release Maintenance & Education Maintain eshare catalog Create and QC metadata extracts Update catalog Execute communication plan Coordinate with CDISC Education E.g., SHARE API courses 11

12 TA Components & SHARE (1) Examples Assumptions Rules Draft Domains and Variables Controlled Terminologies Normative UG CDASH and ADaM Metadata Domains and Variables In SHARE MDR Coming to SHARE MDR In SHARE Ecosystem 12

13 TA Components & SHARE (2) TAUG WIKI TAUG WIKI TBA TAUG WIKI User account and credentials may be required Follow instructions for CDISC WIKI at and, For CDISC eshare at 13

14 TA Specifications (1) Primary Use: Provides information, for new and proposed domains and variables, on their relationships with versions of SDTM and the SDTMIG Secondary Use: Helpful guide on how to adapt the representation of example data shown in the TAUG to different versions of the standards 14

15 TA Specifications (2) Programmatically traverse all data example pages (left) and process all datasets and variables (right) 15

16 TA Specifications (3) Non-standard variables (a.k.a. supplemental qualifiers) metadata are also processed 16

17 TA Specifications (4) Process for TA Specification Generation* To Automate ~90% of Entire Document * Normative section, excluding informative section such as comments 17

18 TA Specifications (5) Example from TAUG MDD v1.0 (wiki.cdisc.org/x/9pxiaq) 18

19 TA Specifications (6) Per SRC, TA Specifications are now REQUIRED for all TAUGs be created for Public Review (Stage 3b) and updated for Publication (Stage 3c) 19

20 CDASH Metadata (1) Metadata-driven Annotated CRF, e.g., TAUG Major Depression Disorder s MDD Symptoms (wiki.cdisc.org/x/lobdaq) 20

21 CDASH Metadata (2) Rendered annotated CRF using metadata specified 21

22 CDASH Metadata (3) Same style, consistent look-and-feel WYSIWYG (S for Specify) 22

23 CDASH Metadata (4) Additional TA teams are being piloted to develop CDASH metadata for TAUG using CRF Maker macros Examples in CDASHIG will be updated, after v2.0 publication, to be using CRF Maker macros 23

24 Questionnaires, Ratings, Scales Metadata (1): Curation Process Stage 0 & 1 Identified as enhancement area: high volume, frequent publications, reusable across TA Discuss business requirements Draft concept map Stage 2 Add QRS to SHARE model Develop capture templates on WIKI based on concept map, with ability to direct load into SHARE Stage 3 Pilot for QRS Supplements 24

25 Questionnaires, Ratings, Scales Metadata (2): Concept Map Core Region 25

26 Questionnaires, Ratings, Scales Metadata (3): Response Region 26

27 Questionnaires, Ratings, Scales Metadata (4): Smart Capture Template 27

28 Questionnaires, Ratings, Scales Metadata (5) New controlled terminologies identified, e.g., administration method (a.k.a. modality), response type Richer metadata (as shown in concept map) will lead to richer QRS Supplements 28

29 Coming Attractions Example Library Planned for SHARE ecosystem, e.g., WIKI Versioned, indexed, reviewed, etc. Aims Facilitate gap analysis so that concept developer (Stage 0 & 1) will be able query and review existing concepts Demonstrate implementation use cases for each concept Rules Planned for SHARE MDR Aims Create a unified model for SDTM, SEND, ADaM Pave ways to prospective rules creation Implementation neutral approach Improved Support Experience 29

30 Staying Informed Technology Webinars November 2016 (Register at -tech-webinar-series-transform-project) Every other month in 2017 Standards and SHARE Update Group Sign up at spx?p=54ed18f4-06ec-409d-ad83-e7dfc7168cc3&m SHARE on CDISC website SHARE Access (for Members and Academics) 30

31 BRIDG Model Overview Smita Hastak Samvit Solutions, LLC

32 Topics BRIDG Overview BRIDG Model Backbone Subdomains of the model BRIDG Sub-domains BRIDG Facts BRIDG and CDISC Standards BRIDG Implementation Approaches BRIDG access and user groups 32

33 BRIDG Model BRIDG Biomedical Research Integrated Domain Group Model - A UML class diagram provides a visual representation of concepts of a domain and the relationships between the concepts Scope is Protocol-driven research and translational sciences research Provides rigorous definitions for concepts in clinical research and their relationship to each other Covers Protocol representation, trial design, adverse event, etc. Collaborative standard developed by ISO 33

34 BRIDG Scope & Purpose The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. This domain of interest is further defined as: The data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with postmarket surveillance and adverse event reporting. Purpose is to enable semantic-based interoperability across the translational domain as well among the various stakeholders 34

35 BRIDG Model backbone this is BRIDG v plus Study Protocol Person Study Subject Activities Study Site Observations Observation Results Organization Study Agent Product 35

36 BRIDG Model subdomains this is BRIDG v plus Statistical Analysis Common (Person, Experiment Bio Specimen Animal, Organization, Product, etc.) Protocol Representation (trial design, etc.) Adverse Event Imaging Regulato ry Study Conduct Molecular Biology 36 36

37 BRIDG sub-domains (cont d) Adverse Event: The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes safety issues involving people or products. It also includes activities during or after a research protocol. Biospecimen: The Biospecimen sub-domain includes concepts related to a biologic specimen, including collection and processing. Common: The Common sub-domain represents the semantics that are common to all (or most) of the other sub-domains. For example, it includes semantics for such things as people, organizations, places and materials. Experiment: The Experiment sub-domain includes concepts related to the design, planning, resourcing and execution of experiments, which are intended to test hypotheses or lead to discoveries. Molecular Biology: The Molecular Biology sub-domain represents the core concepts related to this domain, including gene, protein, molecular sequence, chromosome, genome, and numerous other related concepts. Also includes the representation of these concepts in bioinformatics resources, such as public databases. 37

38 BRIDG sub-domains Protocol Representation: The Protocol Representation sub-domain is intended for those involved in the planning and design of a research protocol. The majority of business requirements have come from those involved in clinical trial protocols. It focuses on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs". It also includes the definitions of the roles that participate in those activities. Regulatory: The Regulatory sub-domain is intended for those involved in the creation and review of submissions to regulatory authorities. The majority of business requirements come from the regulated product submission (RPS) message specification. It focuses on the documentation required for a product submission to the Food and Drug Administration (FDA). Statistical Analysis: The Statistical Analysis Sub-Domain includes concepts describing the planning and performance of the statistical analysis of data collected during clinical trial research and their relationships. Study Conduct: The Study Conduct sub-domain is intended for those involved in the execution of a research study. The majority of business requirements have come from those involved in clinical trials. It focuses on the activities of conducting the study as well as the results from those activities. 38

39 Concepts in some sub-domains Common: The Common sub-domain represents the semantics that are common to all (or most) of the other sub-domains. For example, it includes semantics for such things as people, organizations, places and materials. Subset of Blue classes are listed here) BiologicEntity ExperimentalUnit Person Animal Organization CooperativeGroup Document DocumentAuthor DocumentReceiver Product & it s subtypes Subject StudySubject 39

40 Concepts in some sub-domains Protocol Representation: The Protocol Representation sub-domain is intended for those involved in the planning and design of a research protocol. The majority of business requirements have come from those involved in clinical trial protocols. It focuses on the characteristics of a study and the definition and association of activities within the protocols, including "arms" and "epochs". It also includes the definitions of the roles that participate in those activities. Key classes: StudyProtocolDocument StudyProtocolVersion and subclasses: Interventional, Observational, Expanded Access StudyPersonnel StudyInvestigator StudyLegalSponsor StudyResource StudyObjective StudyOutcomeMeasure Arm Epoch 40

41 Concepts in some sub-domains Adverse Event: The Adverse Event sub-domain is intended for those involved in safety related activities; such as detection, evaluation, follow-up and reporting. This includes safety issues involving people or products. It also includes activities during or after a research protocol. Key classes: AdverseEvent AdverseEventActionTaken AdverseEventOutcome-Assessment AdverseEventOutcome-Result CausalAssessment EvaluatedActivity EvaluatedResult 41

42 Other Information about the Model BRIDG is maintained in a Sparx System s Enterprise Architect UML tool BRIDG is the latest BRIDG release -- composed of 296 classes; 796 attributes which are fully annotated with comprehensive definitions and examples Released in July 2016 Primarily built with a bottom-up approach, i.e. new semantics are added to the BRIDG model by a process of harmonization. Projects bring their models to the BRIDG Modeling team and the teams work together to harmonize the new semantics into the BRIDG model Finally, the BRIDG model is only as rich as the semantics that were/are brought to it by the larger clinical research community. 42

43 BRIDG and CDISC Standards The following CDISC Standards have been harmonized with BRIDG model SDTM IG 3.1.2, CDASH v1.1 Protocol Representation Model SDTM IG PGx v1.0 Oncology TA domains/variable The mappings have been captured as tags in the BRIDG model file 43

44 SDTM to BRIDG Mapping Spreadsheet 44

45 SDTM tags in BRIDG File Tag Names Tagged Values 45

46 BRIDG as a DIM Purpose is to enable semantic-based interoperability across the translational domain as well among the various stakeholders BRIDG is referred to as a Domain Analysis Model (DAM) or a Domain Information Model (DIM) A DIM is used as reference material in development of information system interoperability specifications. The DIM is a requirement specification and therefore rich in domain semantics. It is the primary artifact from which information system design specifications are derived. Logical and Physical models can be built from BRIDG. These design models are built by constraining the needed BRIDG classes/attributes/associations that are scoped to a particular set of use cases/business scenarios. The preferred language for expression of a domain analysis model is UML 46

47 BRIDG Implementation Approaches Reference Model Source for clinical research data semantics & foundation model Data Integration/Mapping Solutions One mapping to a standard rather than multiple point to point mappings Exchange Format Subsets of BRIDG classes represented in XSD/XML Physical Database Generate logical and physical database models in support of clinical research software solutions Ontology To develop clinical research ontology 47

48 Current BRIDG activities Working on next BRIDG release planned for January 2017 Imaging semantics that are harmonized with DICOM Some vendor semantics Some recommended vocabulary value sets Oncology View of BRIDG (with Oncology Therapeutic Areas) January 2017 release will be published as a joint ballot between CDISC, HL7 and ISO Developing modeling-by-reference methodology to support the interoperability between various domains of healthcare 48

49 BRIDG Model website (bridgmodel.org) 49

50 BRIDG Model html version 50

51 BRIDG Work Group BRIDG related issues and items are discussed on the HL7 BRIDG wg Open items are posted on the BRIDG wiki at Note: In HL7 BRIDG and RCRIM WG are going to be merged in next few months 51

52 Q&A 52

53 CDISC Online Education & Event Updates John Ezzell, CDISC 53

54 Upcoming Webinars Presenter Topic Webinar Date Vasa Curcin, TRANSFoRm Project Brendan Delaney, TRANSFoRm Project Piotr Brodka, TRANSFoRm Project Stanislaw Saganowski, TRANSFoRm Project Radosław Michalski, TRANSFoRm Project Dave Iberson-Hurst, Assero CDISC Tech Webinar Series: TRANSFoRm Project & Assero 10 NOV 2016 Webinar details and registration at 54

55 Standard currently out for review Draft Content SDTMIG v3.3 Batch 3 Comments Due by: October 21, 2016 Glossary Public Review Comments Due by: November 2, 2016 New Draft Ebola v1 Comments Due by: November 4, 2016 New Draft Malaria Therapeutic Area User Guide v1 Comments Due by: November 6,

56 UPCOMING NORTH AMERICA PUBLIC COURSES Location Dates Courses Offered: Discount period ends: Late fees kick(ed) in: Host Miami, FL Jan 2017 Raleigh, NC Audubon, PA Toronto, ON 27 Feb 3 Mar Apr June 2017 SDTM, CDASH, ADaM Primer, ADaM T&A SDTM, CDASH, ADaM Primer, ADaM T&A SDTM, CDASH, ADaM Primer, ADaM T&A, CT, Define-XML SDTM, CDASH, ADaM Primer, ADaM T&A, Define-XML 23 Oct Dec Nov Jan Jan Mar Mar May 2017 Visit cdisc.org/public-courses for information on other CDISC Public Training events. 56

57 UPCOMING EUROPE PUBLIC COURSES Location Dates Courses Offered: Discount period ends Late fees kick(ed) in: Host Basel, Switzerland 7-11 Nov 2016 SDTM, ADaM Primer, ADaM T&A, Define-XML Ended 7 Oct London, UK Apr 2017 TBD TBD TBD Visit cdisc.org/public-courses for information on other CDISC Public Training events. 57

58 UPCOMING ASIA PUBLIC COURSES Location Dates Courses Offered Discount period ends: Late fees kick(ed) in: Host Shanghai, China 17-18, Oct SDTM, CDASH, ADaM Primer, ADaM T&A, ODM, Define-XML Ended None Tokyo, Japan 5-9 Dec SDTM, CDASH, ADaM Primer, ADaM T&A, ODM, Define-XML Ended 5 Nov Hyderabad, India Dec CDISC Overview, SDTM, CDASH Ended None Visit cdisc.org/public-courses for information on other CDISC Public Training events

59 CDISC Online Training Production Update Just Released ADaM Module 4 Online Training Mini-Training: Ensuring USUBJID is Unique for an Individual in an Application Online Courses in Development TA Alzheimer's TA QT Studies TA Vaccines TA Prostate Cancer TA Rheumatoid Arthritis TA Pain ADaM Modules 5-8 CT Module 1 & 2 Define-XML 60

60 Any more questions? Thank you for attending this webinar. CDISC s vision is to: Inform Patient Care & Safety Through Higher Quality Medical Research 61

61 CDISC Members Drive Global Standards Thank you for your support! 62 Learn CDISC from CDISC! Authoritative. Global. Vendor neutral. 62