7. German CDISC User Group Meeting Define

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Presentation transcript:

7. German CDISC User Group Meeting Define 7. German CDISC User Group Meeting Define.xml Generator ODM Validator (define.xml validation) 2010/03/11 Dimitri Kutsenko Marianne Neumann

Define.xml Generator – Key Features Full version (entimICE Module): Repository for metadata, data, code lists… GUI based support for links and dependencies All changes versioned and audited Extraction of page numbers from aCRF Light version: SAS Macro (SAS Base only) Metadata passed via parameters and configuration file © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

Define.xml Parts Define.xml Domain level metadata Attribute level Value level metadata Controlled terminology Define.xml External dictionary references link link Algorithms Transport files Annotated CRF © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

define.xml: Attribute Level Metadata Structural SDTM metadata with references to terminology, dictionaries… name type length cdisc_type cdisc_role, cdisc_core… © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

define.xml: Domain Level Metadata Object metadata (properties) on SDTM domain templates CDISC_class CDISC_purpose CDISC_description CDISC_structure © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

define.xml: Controlled Terminology Managed as code lists Bundled to format catalogs Referenced in attribute metadata (no formats on datasets) Found via search path (study level) © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

define.xml: Value Level Metadata Managed as datasets (e.g. lb_topic) Addressed via link to datasets (per domain) © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

define.xml: Algorithms Definitions are stored as datasets (e.g. algo) Addressed via link Reference in attribute metadata © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

Extract pages from aCRF Action looks through comments AND content and writes page numbers into metadata column cdisc_crf_pages © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

Define.xml Generation Magic Button  © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

ODM Checker entimICE Tools © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

ODM Checker - Key Features Define.xml checks supported as extended ODM format State-of-the-art “SAS free” technology (Skala/Java) Validated, stand-alone tool Configurable parameters in the control file entimICE module Seamless integration with other tools/modules Checks (ca. 400 in total) Xml Scheme (nodes, attributes..) Content (references, ids, type/iso…) © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com

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