7 German CDISC User Group Meeting Define xml

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 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 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… § 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 § 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 § 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 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 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 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 | 10243 Berlin | www. entimo. com Confidential | 11. 03. 2010 10

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 § 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