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

2. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com2 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

3. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com3 Define.xml Parts Domain level metadata Attribute level metadata Value level metadata Controlled terminology External dictionary references Define.xml Transport files Annotated CRF Algorithms link

4. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com4 define.xml: Attribute Level Metadata  Structural SDTM metadata with references to terminology, dictionaries…  name  type  length  cdisc_type  cdisc_role, cdisc_core…

5. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com5 define.xml: Domain Level Metadata  Object metadata (properties) on SDTM domain templates  CDISC_class  CDISC_purpose  CDISC_description  CDISC_structure

6. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com6 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)

7. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com7 define.xml: Value Level Metadata  Managed as datasets (e.g. lb_topic)  Addressed via link to datasets (per domain)

8. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com8 define.xml: Algorithms  Definitions are stored as datasets (e.g. algo)  Addressed via link  Reference in attribute metadata

9. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com9 Extract pages from aCRF  Action looks through comments AND content and writes page numbers into metadata column cdisc_crf_pages

10. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com10 Define.xml Generation  Magic Button

11. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com11 entimICE Tools ODM Checker

12. Confidential | 11.03.2010 © Entimo AG | Stralauer Platz 33-34 | 10243 Berlin | www.entimo.com12 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…)