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

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

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

4. 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

5. 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

6. 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

7. References
XML Schema Validation for Define.xml ( 6b477151fcaa9f465166/misc/definereport_v1_0.pdf)
CDISC German Speaking User Group Meeting, 11-Mar-2010

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