Advantages of a realend-to-end approachwith CDISC standards

Dr. Philippe VerplanckeCEOXClinical GmbH

26th AnnualEuroMeeting

25-27 March 2014ACV, Vienna

Austria

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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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Any questions?

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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

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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

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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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• It is easier than you think

• It is easier than the vendors say

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CDISC end-to-end

Questions?

• Contact philippe.verplancke@xclinical.com

• Visit us at exhibition booth # X.314

• www.xclinical.com• XClinical GmbH

Arnulfstrasse 1980335 MunichGermanyTel. +49 89 4522775000E-mail: info@xclinical.com

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