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Implementing metadata standards at the protocol level

Implementing metadata standards at the protocol level. Phuse Berlin October 2010 Annabel Acs aacs@novonordisk.com. Standard. Technology. Process. The standards and technology at NN. CDW. Std. EOT XXCgfg hghj dklædfjkll sdfkf jklsd ----------------------------------- Xxxx

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Implementing metadata standards at the protocol level

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  1. CD12 - Implementing metadata standards at the protocol level Implementing metadata standards at the protocol level Phuse Berlin October 2010 Annabel Acs aacs@novonordisk.com

  2. CD12 - Implementing metadata standards at the protocol level

  3. CD12 - Implementing metadata standards at the protocol level Standard Technology Process

  4. CD12 - Implementing metadata standards at the protocol level The standards and technology at NN CDW Std. EOT XXCgfg hghj dklædfjkll sdfkf jklsd ----------------------------------- Xxxx Xxx 1223 456. 7789.0 Xxxx 1223 456. 7789.0 Xxxx 1223 456. 7789.0 OC Visits Elements Subject Events (AE/Hypo/x) Interventions Responses Numeric Findings Categoric Findings Table Table Protocol Standards CRF Standards CRF CRF Submission Standard CRF Date: / / Abc: x: y: Qwr: CDISC SDTM Data Domain: PE <XML> .… CDISC ADaM Data Domain: ADPE <XML> .… Standard DCM/DVGs Mapping rules Standard Reports Standard Mappings Standard Code Values

  5. CD12 - Implementing metadata standards at the protocol level The process supporting standards and technology at NN Trial Management Data Management Programmers and Statisticians

  6. PMT technology • Protocol Metadata Template (Excel) • Inexpensive • Easy to use • Easy to modify • Familiar to everyone

  7. CD12 - Implementing metadata standards at the protocol level WBC Leucocytes White Blood Cells Protocol Metadata Template standards

  8. CD12 - Implementing metadata standards at the protocol level Trial Design defined in CDW-O with protocol attributes

  9. CD12 - Implementing metadata standards at the protocol level Protocol Draft Protocol Metadata Template Protocol 1.0 The process supporting the standards and technology

  10. CD12 - Implementing metadata standards at the protocol level Trial Mng Data Mng Programmers and Statisticians Medical Writers The process supporting the standards and technology • Time • New tool • Admin.

  11. CD12 - Implementing metadata standards at the protocol level Trial Mng Data Mng Programmers and Statisticians Medical Writers Improving the process… SOPs Training Mng Attn. New Processes

  12. CD12 - Implementing metadata standards at the protocol level Vision for future Clinical System Architecture Portal Other eRecords eRandom Coding IWRS EDC LAB Safety SCE CTMS BI cBI PACT eCTD Dictionaries Analyze Publish Set Up Conduct Training & Processes Master Data Metadata Repository Clinical Source Data Repository Enriched Clinical Data Repository Submission Outputs Repository eStandard eProtocol eDCS eSPS ePSPS Set-up Verify Enrich Analyse Process Data Repository

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