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Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations Development 13 Data Cleaning Using ODM CDISC ESUG Meeting Andrew Newbigging Vice President, Integrations Development 13 th 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.

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions

Introduction Medidata uses ODM to integrate e. Clinical systems • Metadata driven integrations support Introduction Medidata uses ODM to integrate e. Clinical systems • Metadata driven integrations support “define-once” strategy, or DRY (“Don’t Repeat Yourself”) • ODM provides good support form and question definitions • How much of the data validation specification can be included in ODM? • Design Capture Analyze SDTM CDASH ODM ODM Import / Export Metadata Import Clinical Data Metadata Library E 2 B e. Diary IVRS LIMS © 2010 Medidata Solutions Worldwide Export Transform & Export Operational Extract (S)AE Case Datasets Data Safety SAS CTMS Analysis Warehouse Payment 3

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions

ODM 1. 3 – Features - Data. Type • ODM 1. 3 introduced typed ODM 1. 3 – Features - Data. Type • ODM 1. 3 introduced typed data definitions: • So we know that this data is not valid: • Data values can also be checked against Data. Type attribute (ODM 1. 2 and 1. 3): © 2010 Medidata Solutions Worldwide 5

ODM 1. 3 – Features - Length Constrain acceptable size of text, string, integer ODM 1. 3 – Features - Length Constrain acceptable size of text, string, integer and float data items: © 2010 Medidata Solutions Worldwide 6

ODM 1. 3 – Features - Code. List Constrains data values to a specified ODM 1. 3 – Features - Code. List Constrains data values to a specified list: © 2010 Medidata Solutions Worldwide 7

ODM 1. 3 – Features - Range. Check Specification of simple uni-variate checks © ODM 1. 3 – Features - Range. Check Specification of simple uni-variate checks © 2010 Medidata Solutions Worldwide 8

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions

ODM 1. 3 - Limitations Formal. Expression contains free text – no specification of ODM 1. 3 - Limitations Formal. Expression 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 • © 2010 Medidata Solutions Worldwide 10

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions

Vendor Extensions ‘Recommended for … information that cannot be expressed conveniently in the ODM 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 • © 2010 Medidata Solutions Worldwide 12

Vendor Extensions - Example © 2010 Medidata Solutions Worldwide 13 Vendor Extensions - Example © 2010 Medidata Solutions Worldwide 13

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions

Future Plans Medidata already makes extensive use of automated application software testing using Cucumber: Future Plans Medidata 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/ © 2010 Medidata Solutions Worldwide 15

Using Gherkin to define edit checks © 2010 Medidata Solutions Worldwide 16 Using Gherkin to define edit checks © 2010 Medidata Solutions Worldwide 16

Multi-variate checks © 2010 Medidata Solutions Worldwide 17 Multi-variate checks © 2010 Medidata Solutions Worldwide 17

Cross form checks © 2010 Medidata Solutions Worldwide 18 Cross form checks © 2010 Medidata Solutions Worldwide 18

Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Agenda Introduction ODM 1. 3 - Features ODM 1. 3 - Limitations Vendor Extensions Future Plans Questions