1 / 8

Monika Kawohl Statistical Programming Accovion GmbH

Validation of define.xml. Monika Kawohl Statistical Programming Accovion GmbH. Overview. Schema Validation Content Validation. Schema Validation Sample. Annotated CRF. Requirements eCTD Portable Document Format Specifications/ CDISC Draft Metadata Submission Guidelines SDTM content

orien
Download Presentation

Monika Kawohl Statistical Programming Accovion GmbH

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Validationofdefine.xml Monika Kawohl Statistical Programming Accovion GmbH

  2. Overview • Schema Validation • Content Validation

  3. Schema Validation Sample

  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

  5. Define.xml (SDTM) • Requirements • 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

  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

  7. References • XML Schema Validation for Define.xml(http://www.cdisc.org/stuff/contentmgr/files/0/464923b10ea16b477151fcaa9f465166/misc/definereport_v1_0.pdf)

  8. Thank you!Questions?

More Related