Transcript Roche Template - Digital Infuzion, Inc.

Diagnostics Clinical Information Management
(CIM) Services
Field Report: Implementation of CDISC ODM
Michael Walter
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
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
CIM System
Validated, Highly-Integrated Web Application
USER
Internet
Intranet
https://cim.roche.net
Portal
Data
Results
Study, Site, Subject,
Sample & Device
Reports &
Listings
XML, XLS, CSV
Study
Data
Site
Data
Subject
Data
Sample
Data
Interfaces
Device
Data
CRF
Print
XML, CDISC, XLS,
CSV
CDISC ODM
Implementation Approach and Timelines
Implementation
and Validation
Presentation of
prototype and
agreement with
the CIM
Customers
Prototype
Mid/End 2007
CRF-Printing
productive
Interface CIM
SAS
productive
May 2008
August 2008
CDISC ODM
Structure
CDISC ODM Export
Application Fields
Interface CIM SAS
……..
CRF-Printing
Interface CIM SAS
using SAS Proc CDISC
SAS Proc CDISC
SAS
CIM
CDISC ODM Export
Interface CIM SAS
Example
One SAS Dataset per
eCRF
One SAS Dataset per Domain
One SAS Dataset per Study
CRF-Printing
using XSL stylesheets
Empty CRF
CDISC ODM Export
CRF-Like Printouts
CIM
Annotated CRFs
XSL stylesheets
Blank CRFs
CRF-Printing
Example
Submission
Statistical
Programming
Data Review
Data Capture
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
Interface CIM SAS
…….
Importing
Archiving
…….
CRF-Printing
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