Monika Kawohl Statistical Programming Accovion GmbH

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Presentation transcript:

Monika Kawohl Statistical Programming Accovion GmbH Validation of define.xml Monika Kawohl Statistical Programming Accovion GmbH

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

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

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

Define.xml (SDTM) Requirements QC Steps CRT-DDS (define.xml) V1.0 CDISC Draft Metadata Submission Guidelines eCTD Validation Criteria Location and modification of stylesheets Consistent with SDTM specifications & data QC Steps Schema Validation Correct Hyperlinks in eCTD structure Process => Built-in consistency with specifications & data CDISC German Speaking User Group Meeting, 11-Mar-2010

Define.xml (ADaM) Requirements ADaM V2.1, ADaM IG V1.0 Metadata concept eCTD Validation Criteria Placement and modification of stylesheets Supplemental data definitions (extension of metadata concept) Consistent with specifications & data QC Steps Schema Validation Correct Bookmarks & Hyperlinks in eCTD structure Process => Built-in consistency with specifications & data CDISC German Speaking User Group Meeting, 11-Mar-2010

References XML Schema Validation for Define.xml (http://www.cdisc.org/stuff/contentmgr/files/0/464923b10ea1 6b477151fcaa9f465166/misc/definereport_v1_0.pdf) CDISC German Speaking User Group Meeting, 11-Mar-2010

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

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