data cleaning using odm cdisc esug meeting andrew newbigging vice president, integrations...
DESCRIPTION
© 2010 Medidata Solutions Worldwide 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? Introduction DesignAnalyzeCapture Transform & Extract Datasets Export (S)AE Case Data Import Clinical Data Import / Export Metadata Metadata Library eDiary IVRS LIMS SafetySAS Analysis Warehouse CTMS Payment Export Operational Data E2BODMODM CDASH SDTM ODM 3TRANSCRIPT
Data Cleaning Using ODMCDISC ESUG Meeting
Andrew NewbiggingVice President, Integrations Development13th 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.
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda
© 2010 Medidata Solutions Worldwide
• 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?
IntroductionDesign AnalyzeCapture
Transform &Extract
Datasets
Export(S)AE Case
Data
ImportClinical Data
Import /Export
Metadata
Metadata Library
eDiary
IVRS
LIMS
Safety SAS
AnalysisWarehouse
CTMS
Payment
ExportOperational
Data
E2BE2BODMODMODMODM
CDASHCDASH SDTMSDTMODMODM
3
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda
© 2010 Medidata Solutions Worldwide
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):
5
© 2010 Medidata Solutions Worldwide
ODM 1.3 – Features - LengthConstrain acceptable size of text, string, integer
and float data items:
6
© 2010 Medidata Solutions Worldwide
ODM 1.3 – Features - CodeListConstrains data values to a specified list:
7
© 2010 Medidata Solutions Worldwide
ODM 1.3 – Features - RangeCheckSpecification of simple uni-variate checks
8
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda
© 2010 Medidata Solutions Worldwide
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
10
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda
© 2010 Medidata Solutions Worldwide
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
12
© 2010 Medidata Solutions Worldwide
Vendor Extensions - Example
13
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda
© 2010 Medidata Solutions Worldwide
Future PlansMedidata 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/15
© 2010 Medidata Solutions Worldwide
Using Gherkin to define edit checks
16
© 2010 Medidata Solutions Worldwide
Multi-variate checks
17
© 2010 Medidata Solutions Worldwide
Cross form checks
18
IntroductionODM 1.3 - FeaturesODM 1.3 - LimitationsVendor ExtensionsFuture PlansQuestions
Agenda