Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations...

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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

• 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

ImportClinical Data

Import /Export

Metadata

Metadata Library

eDiary

Safety SAS

AnalysisWarehouse

Payment

ExportOperational

E2BE2BODMODMODMODM

CDASHCDASH SDTMSDTMODMODM

Agenda

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):

ODM 1.3 – Features - LengthConstrain acceptable size of text, string, integer

and float data items:

ODM 1.3 – Features - CodeListConstrains data values to a specified list:

ODM 1.3 – Features - RangeCheckSpecification of simple uni-variate checks

Agenda

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

Agenda

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

Vendor Extensions - Example

Agenda

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

Using Gherkin to define edit checks

Multi-variate checks

Cross form checks

Agenda

Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations...

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