7 German CDISC User Group Meeting Define xml

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7. German CDISC User Group Meeting Define. xml Generator ODM Validator (define. xml validation)

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 (entim. ICE Module): § Repository

Define. xml Generator – Key Features § Full version (entim. ICE Module): § Repository for metadata, code lists… § GUI based support for links and dependencies § All changes versioned and audited § Extraction of page numbers from a. CRF § 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 Confidential | 11. 03. 2010 2

Define. xml Parts Domain level metadata Attribute level metadata Value level metadata Controlled terminology

Define. xml Parts Domain level metadata Attribute level metadata Value level metadata Controlled terminology Define. xml link Transport files External dictionary references link Annotated CRF © Entimo AG | Stralauer Platz 33 -34 | 10243 Berlin | www. entimo. com Algorithms Confidential | 11. 03. 2010 3

define. xml: Attribute Level Metadata § Structural SDTM metadata with references to terminology, dictionaries…

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 Confidential | 11. 03. 2010 4

define. xml: Domain Level Metadata § Object metadata (properties) on SDTM domain templates §

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 Confidential | 11. 03. 2010 5

define. xml: Controlled Terminology § Managed as code lists § Bundled to format catalogs

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 Confidential | 11. 03. 2010 6

define. xml: Value Level Metadata § Managed as datasets (e. g. lb_topic) § Addressed

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 Confidential | 11. 03. 2010 7

define. xml: Algorithms § Definitions are stored as datasets (e. g. algo) § Addressed

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 Confidential | 11. 03. 2010 8

Extract pages from a. CRF § Action looks through comments AND content and writes

Extract pages from a. CRF § 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 Confidential | 11. 03. 2010 9

Define. xml Generation Magic Button © Entimo AG | Stralauer Platz 33 -34 |

Define. xml Generation Magic Button © Entimo AG | Stralauer Platz 33 -34 | 10243 Berlin | www. entimo. com Confidential | 11. 03. 2010 10

entim. ICE Tools ODM Checker © Entimo AG | Stralauer Platz 33 -34 |

entim. ICE Tools ODM Checker © Entimo AG | Stralauer Platz 33 -34 | 10243 Berlin | www. entimo. com Confidential | 11. 03. 2010 11

ODM Checker - Key Features § Define. xml checks supported as extended ODM format

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 § entim. ICE 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 Confidential | 11. 03. 2010 12