Monika Kawohl Statistical Programming Accovion GmbH

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Monika Kawohl Principal Statistical Programmer Accovion
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Presentation transcript:

Monika Kawohl Statistical Programming Accovion GmbH define.xml Outlook ADaM Metadata Requirements Monika Kawohl Statistical Programming Accovion GmbH

ADaM Documentation (Metadata) Analysis Results Metadata For key analyses only Analysis Dataset Metadata Analysis Variable Metadata including Parameter Value-Level Metadata CDISC German Speaking User Group Meeting, 11-Mar-2010

Analysis Results Sample Display Result 1 CDISC German Speaking User Group Meeting, 11-Mar-2010

Analysis Results Metadata Permissible although very user/reviewer friendly CDISC German Speaking User Group Meeting, 11-Mar-2010

ADaM Dataset Metadata column NOT Link to in define.xml, dataset Link to analysis variable metadata => next slide column NOT in define.xml, contents sponsor specific CDISC German Speaking User Group Meeting, 11-Mar-2010

Analysis Variable Metadata including Parameter Value-Level Metadata CDISC German Speaking User Group Meeting, 11-Mar-2010

Further Documentation Supplemental Data Definitions Supplementaldatadefinitions.pdf Per study, specific data analysis Textual description Data dependencies, flow charts Reviewers‘ Guide PDF document Per submission Submission specifics High level folder structure, contents Similarities across studies/analyses CDISC German Speaking User Group Meeting, 11-Mar-2010

References Analysis Data Model, V2.1 (http://www.cdisc.org/adam) 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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