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Advantages of a realend-to-end approachwith CDISC standards
Dr. Philippe VerplanckeCEOXClinical GmbH
26th AnnualEuroMeeting
25-27 March 2014ACV, Vienna
Austria
DisclaimerThe 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.
CDISC end-to-end: the bestkept 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
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Use CDISC for ALL purposes,not just submission to FDA
TerminologyHow do we call things?
• CDISC SHAREMetadata Repository
StructureWhere 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)
FormatPurpose: storeand exchange data and metadata
• XML• ASCII• SAS
CDISC end-to-end = use allstandards for all process steps
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„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
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) BEFOREstarting 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
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• 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
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How to implement CDISC end-to-end?
CRF metadata and SDTM metadatacontain the same value-level metadata
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CRF-Page
SYSBP MMHG
DIABP MMHG
Systolic blood pressure _ _ _ mmHg
Diastolic blood pressure _ _ _ mmHg
VS Domain
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CRF metadata and SDTM metadatacontain the same pieces of XML
Visit MetadataForm Metadata
Item Metadata= value-level metadata
Domain Metadata
ODM.xml
CR
F D
esig
n
define.xml
Submission
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CDISC end-to-end technology
SDTMADaM
Standard Analysis
Extraction,Transformation,
Loading
ODMExport
EDC(ODM)
Shared value-level metadata in XML
Operational EDC/CDMDatabase;Normalized;Vertical
Analysis & SubmissionDatabase;Denormalizedpartially horizontal
CRF Design
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
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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
Old process
New process
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Example: eliminate transcription & programming
XLS
EDC
EDC
Metadata inExcel sheets from cdisc.org
CDISC value-level metadata in define.xml
Manual transfer Manual transfer/set-up
Automated transfers
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
Advantages, advantages, advantages
Old process
New process
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Example: eliminate 75 % of manual steps
CDISC ODM-based CRF design
tool
Specs Annotated CRF
XLSDOC
PDFPDF
DOC
XLS
PDFPDFEDC
EDC
Programming
①
②
③ ④
① Automatic set-up
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
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
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Advantages, advantages, advantages
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
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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)
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Questions?
• Contact [email protected]
• Visit us at exhibition booth # X.314
• www.xclinical.com• XClinical GmbH
Arnulfstrasse 1980335 MunichGermanyTel. +49 89 4522775000E-mail: [email protected]
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