Diagnostics Clinical Information Management (CIM) ServicesField Report: Implementation of CDISC ODMMichael Walter

Mission CIM ServicesProvide 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

Scope CIM ServiceseCRF 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

CIM System Validated, Highly-Integrated Web Application

Portal

Sample Data

Device Data

Study Data

Subject Data

Interfaces

XML, XLS, CSV XML, CDISC, XLS, CSV

https://cim.roche.net

USER

Data Study, Site, Subject,

Sample & Device

ResultsReports & Listings

IntranetInternet

SiteData

CRF Print

CDISC ODMImplementation Approach and Timelines

Prototype

Presentation of prototype and agreement with the CIM Customers

Interface CIM SAS productive

CRF-Printing productive

Mid/End 2007

May 2008

August 2008

Implementation and Validation

CDISC ODM Structure

GT_HIV_173

CDISC ODM Export Application Fields

CRF-Printing

Interface CIM SAS

……..

Interface CIM SASusing SAS Proc CDISC

SAS Proc CDISC

CDISC ODM Export

CIM SAS

Interface CIM SASExample One SAS Dataset per

eCRF

One SAS Dataset per Domain

One SAS Dataset per Study

CRF-Printing using XSL stylesheets

CIM

CDISC ODM Export

XSL stylesheets

Empty CRF

CRF-Like Printouts

Annotated CRFs

Blank CRFs

CRF-Printing Example

GT_HIV_173_filledData Capture

Data Review

StatisticalProgrammi

ng

Submission

GT_HIV_173_empty

GT_HIV_173_blank

GT_HIV_173_annotated

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.

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.

Our Next Steps

CRF-Printing

Interface CIM SAS

Archiving

…….

…….

Importing

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