Page History

Clinical Governance Group

John Speakman CTMS Wiki - Storyboards and Semantic Profiles for services interoperabilty

Patrick McConnell (21090)

ScenPro Analyst and 5AM, ISO Datatype Documentation of ISO use for COPPA (all projects have to use the datatypes) Implementation of guidelines must be complete in June

-'Operationalized' ISO 21090 Datatypes
- Discover and share/reuse models
- Rules engine and repository:
Scenario #8: Management of Routine Non-Laboratory-Based Adverse Events (caAERS and CDMS) - Protocol Metadata and Rules Engine
- C3PR FR-230 The system must integrate with the Cancer Data Standards Repository (caDSR) and Enterprise Vocabulary Services (EVS) (e.g. for eligibility criteria)

MediData

(Dianne Reeves)

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Data Elements on Forms: Metadata registry information and semantic metadata, specifically data elements (CDEs) to record and share centrally defined forms variables that can be used to customize new protocols for clinical trials

- Share Forms including form structure, behavior and variables - similar to the way C3D uses caDSR but may have additional metadata that needs to be stored/shared

Genzyme

Sue Dubman
Julie Smiley Director, Data Management
Genzyme Oncology)

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MDR metadata exchange -->Implement global data standards to collect, process, analyze and report clinical research data throughout the entire product lifecycle (see GetSmart attachment)

- share data standards and variables (CDEs)
- Get Smart Goal #2 Data Collection and Processing: Technology enabled standard Case Report Forms and edit checks.
- Get Smart Goal #5 Core Infrastructure: Data Elements Dictionary, Validation Tools, Systems Interoperability Guidelines and Architecture, Metadata Repository, Mapping and Conversion Tools and Structured Authoring Tool

Medical and Scientific Researchers

Yolanda Gill

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Workflow: Metadata and rule support

- Metadata to support workflow

MD Anderson

Mike Riben

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Alignment/Interoperability between NCI and MD Anderson's metadata and vocabulary solutions; Possible UAT(See MD Anderson Attachment)

- Metadata Registry Interoperability

Emory

Stuart Turner, Eliot Seigel and Joel Saltz

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Semantic interoperation requirement stemming from the TCGA Radiology and In Silico projects. See Attached use case with 4 semantic requirements identified.

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Novartis

Mehta Saurin

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MDR tools
ie.
1) Alternate names for permissible values i.e. currently you can register 'M', 'MALE' but we would like to register additional name such as 'm', '1', 'Male' etc.
2) Additional attributes for a data element - although there is a reference field available we would want (for operational purposes) additional attributes to define items such as 'SAS format', display format etc.
3) if the list of permissible values is Extensible flag
4) A way to relate data elements to each other
5) Distributed repository

- Enhanced/standardizxed Metadata attributes
- Metadata Registry Interoperability

CDISC and SHARE

Margaret Haber

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Pilot of Semantic Media Wiki for harmonizing and updating data elements; Input on tooling and metadata extensions

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Mayo

Robert Friemuth

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new metadata repository and CTS2

- Federated Terminologies

LS Governance and ICR

Juli Klemm, Baris

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caB2B IRWG requirements, caBIG Gene Pattern and Analytical Services interoperability.
Seamless interoperability, discover services and data that can be combined; construct new workflows

- Integrated system of tools (see IRWG Requirements)

- Support workflow authoring tools (such as Taverna and caB2B)

Terminologists

Margaret Haber, Sheri De Coronado

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formal requirements for the new terminology and metadata services and for assessing equivalence between pre- and post- coordinated terminology

See Semantic Infrastructure Concept of Operations Initiative 5 Compliance.]

caBIG Community

Various

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Vocabulary Knowledge Center Semantic Requirements Wiki Forum

See Semantic Infrastructure Concept of Operations Initiatives - Requirements Master List of requirements organized by Semantic Infrastructure initiatives

Software Architects and Designers

Anand Basu
Charlie Mead

Patrick McConnell

Discover and integrate services, on the fly, to perform scientific research

1. build new services that can interact with other existing services using workflow authoring tools such as Taverna
2. Support for "Conformance Profiles" --> Profiles are a mechanism used to constrain broader service capabilities to meet specific functional needs identified within a domain or locality (See Conformance Profiles attachment)

Metadata Curators

Dianne Reeves

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Creating new content in caDSR

1. Customizable metadata download
2. Clinician friendly browsing: improve search and browsing functions, leveraging existing semantics and metadata
3. Improve ability to organize and reuse content (Classifications) with batch upload/editing

FDA

Margaret Haber
Ed Helton

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Metadata and Terminologies

TBD

caEHR

Gilberto Fragoso

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NHIN

?

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Interoperability in standards development

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HL7/CIC

Dianne Reeves

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HL7 ISO 21090 Datatypes; CIC MDR requirements

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