1. 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.

2. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda

3. © 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 3

4. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda

5. © 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

6. © 2010 Medidata Solutions Worldwide ODM 1.3 – Features - Length Constrain acceptable size of text, string, integer and float data items: 6

7. © 2010 Medidata Solutions Worldwide ODM 1.3 – Features - CodeList Constrains data values to a specified list: 7

8. © 2010 Medidata Solutions Worldwide ODM 1.3 – Features - RangeCheck Specification of simple uni-variate checks 8

9. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda

10. © 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

11. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda

12. © 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

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

14. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda

15. © 2010 Medidata Solutions Worldwide 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/ 15

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

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

18. © 2010 Medidata Solutions Worldwide Cross form checks 18

19. Introduction ODM 1.3 - Features ODM 1.3 - Limitations Vendor Extensions Future Plans Questions Agenda