1. Diagnostics Clinical Information Management (CIM) Services Field Report: Implementation of CDISC ODM Michael Walter

2. Mission CIM Services Provide Services to Conduct Clinical Studies Globally Collection of user requirements, implementation and validation of the CIM System* User training and user access management Study registration, programming, release, change mgmt, closure and archival Site initiation, assignment to studies, closure and archival * CIM System is being developed by Clinical Systems Program Management

3. Scope CIM Services eCRF and Paper Based Clinical Studies and Sample Banks In scope –Clinical Programming (eCRFs, validation checks, listings and reports) –Operations (user training, user access, user support, change requests) –Quality Assurance (testing of all deliverables) Out of scope –Study monitoring –Data management –Statistical analysis

4. CIM System Validated, Highly-Integrated Web Application

5. CDISC ODM Implementation Approach and Timelines Prototype Presentation of prototype and agreement with the CIM Customers Interface CIM SAS productive CRF-Printing productive Mid/End 2007 May 2008August 2008 Implementation and Validation

6. CDISC ODM Structure

7. CDISC ODM Export Application Fields CRF-Printing Interface CIM SAS ……..

8. Interface CIM SAS using SAS Proc CDISC SAS Proc CDISC CDISC ODM Export CIM SAS

9. Interface CIM SAS Example One SAS Dataset per eCRF One SAS Dataset per Domain One SAS Dataset per Study

10. CRF-Printing using XSL stylesheets CIM CDISC ODM Export XSL stylesheets Empty CRF CRF-Like Printouts Annotated CRFs Blank CRFs

11. CRF-Printing Example Data Capture Data Review Statistical Programming Submission

12. Conclusion (1) CDISC ODM is a transporting and formatting standard for clinical data between different applications. In our example it serves as interface between CIM and SAS and as a basis for our CRF-printing capabilities. Implementing CDISC ODM reduces programming and maintenance costs, as a given functionality is developed once, but can be used for multiple purposes. CDISC ODM greatly supports the clinical study process and thus contributes to the improvement in quality.

13. Conclusion (2) If CDISC ODM is used for different purposes, this leads to increased dependencies, e. g. the adaptation of the CDISC ODM export needs a verification of the correct functionality of both the CIM SAS interface and the CRF-printing With the implementation of the CDISC ODM standard, system limitations may be reached, e. g. the more complex study, the more data, the bigger CDISC ODM file.

14. Our Next Steps CRF-Printing Interface CIM SAS Archiving ……. Importing

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