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Enhancing Data Quality: ODM 1.3 Features and Future Plans in eClinical Systems

Discover the advancements in data cleaning and integration using ODM 1.3 in clinical research at Medidata. This presentation by Andrew Newbigging focuses on the key features, limitations, vendor extensions, and future plans for ODM 1.3. Learn how ODM supports data validation, structured definitions, and automated testing with tools like Cucumber. Gain insights on ensuring data integrity through effective metadata management and how Medidata employs the "define-once" strategy for efficient eClinical system integration.

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Enhancing Data Quality: ODM 1.3 Features and Future Plans in eClinical Systems

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  1. Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations Development 13th July 2010 Medidata Solutions, Inc. Proprietary - Medidata and Authorized Clients Only. This document contains proprietary information that shall be distributed, routed or made available only within Medidata, except with written permission of Medidata.

  2. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

  3. Introduction • Medidata uses ODM to integrate eClinical systems • Metadata driven integrations support “define-once” strategy, or DRY (“Don’t Repeat Yourself”) • ODM provides good support for form and question definitions • How much of the data validation specification can be included in ODM? Design Capture Analyze Import /ExportMetadata ImportClinical Data SDTM CDASH Transform &ExtractDatasets Export(S)AE CaseData ODM ExportOperationalData ODM ODM E2B eDiary Metadata Library IVRS Safety SAS CTMS LIMS AnalysisWarehouse Payment

  4. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

  5. ODM 1.3 – Features - DataType • ODM 1.3 introduced typed data definitions: • So we know that this data is not valid: • Data values can also be checked against DataType attribute (ODM 1.2 and 1.3):

  6. ODM 1.3 – Features - Length Constrain acceptable size of text, string, integer and float data items:

  7. ODM 1.3 – Features - CodeList Constrains data values to a specified list:

  8. ODM 1.3 – Features - RangeCheck Specification of simple uni-variate checks

  9. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

  10. ODM 1.3 - Limitations • FormalExpression contains free text – no specification of content • Different systems use widely varying implementations (SQL, Javascript, VBScript, C#, SAS procedures, etc) • Difficult to create complex, multi-variate checks that are system-independent and transferrable

  11. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

  12. Vendor Extensions • ‘Recommended for … information that cannot be expressed conveniently in the ODM model’ • Medidata have created vendor extensions to completely represent an EDC study in ODM • Edit checks and derivations are expressed in an XML vendor extension structure

  13. Vendor Extensions - Example

  14. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

  15. Future Plans Medidata already makes extensive use of automated application software testing using Cucumber: ‘Cucumber is a tool that can execute plain-text functional descriptions as automated tests. The language that Cucumber understands is called Gherkin. ‘ http://cukes.info/

  16. Using Gherkin to define edit checks

  17. Multi-variate checks

  18. Cross form checks

  19. Agenda ODM 1.3 - Features Introduction ODM 1.3 - Limitations Vendor Extensions Future Plans Questions

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