Advantages of a real end-to-end approach with CDISC standards

Transcription

1 Advantages of a real end-to-end approach with CDISC standards Dr. Philippe Verplancke CEO XClinical GmbH 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3 CDISC end-to-end: the best kept secret in the industry! 1. Eliminate manual effort and the risk of errors of transcribing SDTM standards from the SDTM database design into the EDC design tool (direct import) 2. Eliminate the effort of transforming the documents published by CDISC in Excel or PDF format into something your CDM software can use 3. Eliminate specification of CRF in MS Word (automatically generated) 4. Eliminate specification of Data Validation Plan in MS Excel (automatically generated) 5. Eliminate manual creation of the annotated CRF (automatically generated) 6. Automatic generation of blank CRF 7. Standards governance built into the process (use of a metadata library) 8. Automatic set-up of an EDC system, strongly reduce the cost and time of EDC programming 9. Strongly reduce the effort and need for EDC user acceptance testing 10. Automate transfer of data and metadata from EDC/CDMS into SAS (including automatic creation of labels and formats; avoid programming effort, avoid transcription errors) 11. Easy and unambiguous exchange of specifications and data with CROs while using different EDC systems 12. Easier import of lab data 13. Library of metadata across all software tools and processes 14. Eliminate effort of legacy data transformation 15. Automatically export data into a good form for archiving as prescribed by FDA guidance 16. Automatically create PDFs with CRF data and audit trail 3

4 Any questions? 4

5 Use CDISC for ALL purposes, not just submission to FDA Terminology How do we call things? CDISC SHARE Metadata Repository Structure Where do we put things? Purpose: Protocol (PRM) Purpose: CRF pages (ODM) Purpose: Lab forms (LAB) Purpose: Data tables (SDTM, define.xml) Purpose: Analysis tables (ADaM) Format Purpose: store and exchange data and metadata XML ASCII SAS 5

6 CDISC end-to-end = use all standards for all process steps End End PRM ODM ODM + LAB ODM ADaM SDTM ODM (!) + SDTM/TA/CT Naming (= CDASH) + define.xml + SDM-XML (study design) + SDS-XML DATA INTEGRATION 6

7 CDISC end-to-end: basic points 1. Use CDISC standards for ALL process steps and in ALL software tools 2. Define the objective (SDTM and ADaM) BEFORE starting the data collection. 3. Automate data transformations based on XML metadata, eliminate scripting That way, CDISC standards will make the CDM process A LOT shorter and A LOT more cost-effective 7

8 How to implement CDISC end-to-end? Create define.xml, including value-level metadata, BEFORE the study starts Use define.xml as a direct source for CRF design not only conceptually but really, with software tools Use the same value-level metadata in all process steps and all software tools 8

9 CRF metadata and SDTM metadata contain the same value-level metadata CRF-Page VS Domain Systolic blood pressure _ mmhg Diastolic blood pressure _ mmhg SYSBP DIABP MMHG MMHG 9

10 CRF metadata and SDTM metadata contain the same pieces of XML CRF Design ODM.xml Visit Metadata Form Metadata Item Metadata = value-level metadata Domain Metadata define.xml Submission 10

11 CDISC end-to-end technology EDC (ODM) CRF Design Operational EDC/CDM Database; Normalized; Vertical ODM Export Extraction, Transformation, Loading Standard Analysis Shared value-level metadata in XML SDTM ADaM Analysis & Submission Database; Denormalized partially horizontal 11

12 Advantages, advantages, advantages RELAX Rest assured and be certain that all necessary data to build SDTM datasets are collected with the right datatype, the right measurement units and the right coding WIN Real time and cost savings (yes, really) ENJOY Data Managers can focus on increasing data quality instead of performing technical programming tasks 12

13 Advantages, advantages, advantages 1. Eliminate manual effort and the risk of errors of transcribing SDTM standards from the SDTM database design into the EDC design tool (direct import) 2. Eliminate the effort of transforming the documents published by CDISC in Excel or PDF format into something your CDM software can use 13

14 Example: eliminate transcription & programming Old process Manual transfer Manual transfer/set-up XLS Metadata in Excel sheets from cdisc.org EDC New process EDC Automated transfers CDISC value-level metadata in define.xml 14

15 Advantages, advantages, advantages 3. Eliminate specification of CRF in MS Word (automatically generated) 4. Eliminate specification of Data Validation Plan in MS Excel (automatically generated) 5. Eliminate manual creation of the annotated CRF (automatically generated) 6. Automatic generation of blank CRF 7. Automatic set-up of an EDC system, strongly reduce the cost and time of EDC programming 15

16 Example: eliminate 75 % of manual steps Old process 1 DOC XLS EDC PDF Specs Programming Annotated CRF New process 1 CDISC ODM-based CRF design tool XLS EDC DOC Automatic set-up PDF 16

17 Advantages, advantages, advantages 8. Standards governance built into the process (use of a metadata library) 9. Strong reduction of the effort and need for EDC user acceptance testing 10. Automate transfer of data and metadata from EDC/CDMS into SAS (including automatic creation of labels and formats; avoid programming effort, avoid transcription errors) 11. Easy and unambiguous exchange of specifications and data with CROs while using different EDC systems 17

18 Advantages, advantages, advantages 12.Easier import of lab data 13. Library of metadata across all software tools and processes 14. Eliminate effort of legacy data transformation 15. Automatically export data into a good form for archiving as prescribed by FDA guidance 16. Automatically create PDFs with CRF data & audit trail 18

19 Apart from the advantages, the FDA wants you to use XML FDA guidance for data archiving strongly recommends using XML for CRF data archiving! The FDA is considering to ask the industry to send clinical data as CDISC SDS-XML files instead of SAS V5 transport files 19

20 Practical questions Do I need to change all my CRF pages to CDASH pages? No, just use the right value-level metadata and put them on any page in any order you want. Do I need to throw away my existing software systems and do a huge investment first? No, just use the define.xml files you already have and use them to generate metadata for your existing EDC system (a couple of hours of work using stylesheets) 20

21 CDISC end-to-end It is easier than you think It is easier than the vendors say 21

22 Questions? Contact Visit us at exhibition booth # X XClinical GmbH Arnulfstrasse Munich Germany Tel info@xclinical.com 22