Validation of define xml Monika Kawohl Statistical Programming

Validation of define. xml Monika Kawohl Statistical Programming Accovion Gmb. H

Overview Schema Validation Content Validation CDISC German Speaking User Group Meeting, 11 -Mar-2010 2

Schema Validation Sample CDISC German Speaking User Group Meeting, 11 -Mar-2010 3

Annotated CRF Requirements • e. CTD Portable Document Format Specifications/ CDISC Draft Metadata Submission Guidelines SDTM content à Annotation legend (standard layout) à Hyperlinks from repeat pages to annotated pages (see page 5) à Bookmarks à Named destinations à • Prepare reference a. CRF QC Steps • Verify requirements • Tool: Checklist • Final check in e. CTD folder structure CDISC German Speaking User Group Meeting, 11 -Mar-2010 4

Define. xml (SDTM) Requirements • CRT-DDS (define. xml) V 1. 0 • CDISC Draft Metadata Submission Guidelines • e. CTD Validation Criteria à Location and modification of stylesheets • Consistent with SDTM specifications & data QC Steps • Schema Validation • Correct Hyperlinks in e. CTD structure • Process => Built-in consistency with specifications & data CDISC German Speaking User Group Meeting, 11 -Mar-2010 5

Define. xml (ADa. M) Requirements • ADa. M V 2. 1, ADa. M IG V 1. 0 à Metadata concept • e. CTD Validation Criteria à Placement and modification of stylesheets • Supplemental data definitions (extension of metadata concept) • Consistent with specifications & data QC Steps • Schema Validation • Correct Bookmarks & Hyperlinks in e. CTD structure • Process => Built-in consistency with specifications & data CDISC German Speaking User Group Meeting, 11 -Mar-2010 6

References XML Schema Validation for Define. xml (http: //www. cdisc. org/stuff/contentmgr/files/0/464923 b 10 ea 1 6 b 477151 fcaa 9 f 465166/misc/definereport_v 1_0. pdf) CDISC German Speaking User Group Meeting, 11 -Mar-2010 7

Thank you! Questions? CDISC German Speaking User Group Meeting, 11 -Mar-2010 8