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Introducing the OpenClinica CRF Library
Liz Watts B.Sc. MICR
March 22, 2010
Agenda
What is the CRF library?
Why is it necessary?
Who is developing, monitoring and maintaining it?
How is it being implemented?
Where does the future lie?
What is the CRF Library?
…What is a library?
”A library is a collection of sources, resources and services, and the structure in which they are housed. It is organized and maintained by a public body, an institution or a private individual.”
Traditionally libraries were – a collection of books.
Now the term “Library” has acquired a secondary meaning
» “a collection of useful material for common use”
What is a Library cont’d….
The ongoing development of technology and electronic accessibility of information causes further evolution of the library concept.
Modern libraries are being redefined as places offering unrestricted access to information in many formats and from many sources, including electronic, with the support and assistance of librarians/technicians and a variety of digital tools.
CRF Library
Collection of Case Report Forms…plus
» Supporting documentation
• Metadata files
• Specifications
• Validation test scripts
• Edit checks
• Implementation guidelines
• CRF Completion Guidelines
Will be ‘managed’ by Akaza/Steering committee members
Two “classes” of CRF will be maintained
» Expert reviewed and Enhanced
» Community
Library content 1…
Expert reviewed and Enhanced» Based on industry standards – CDISC Clinical Data Acquisition Standards
Harmonization (CDASH) Initiative, National Cancer Institute’s (NCI) Cancer Data Standards Repository (caDSR)
» Developed by experienced industry ‘users’ – Steering committee» Reviewed, tested, annotated, documented
• Enhanced metadata• Detailed specifications• Enhanced edit checks• Implementation guidelines• CRF Completion Guidelines
» Ready for use ‘as-is’» Available to OpenClinica Enterprise Subscribers
Library content 2 …
Community
» Contributed by members of the OpenClinica community
» Minimal review by committee
» Available to all OpenClinica users
Why is it necessary?
Reasons to use the library…
Access to existing CRF’s Reduction of study startup time Promotion of use of industry standards eg. CDASH Minimize time and cost of training, testing and validation with use of
standard support documentation Reduction of duplication
Who is developing, monitoring and maintaining it?
The Steering Committee - Mission statement…
The mission of the OpenClinica CRF Library Steering Committee is to represent the interests of the OpenClinica CRF Library stakeholders and to ensure that the project adheres to its fundamental principles expressed in the CRF Library vision statement.
The Steering Committee will work to maximize the clinical research value of the resources available in the CRF Library. The Committee will advise on the stewardship and curation of the resources in the OpenClinica CRF Library and oversee the way these resources are collected, edited, managed, and published.
The Steering Committee - Responsibilities
Advise on the structure, design, content, and operation of the CRF
Library, including:
» CRF Library features, functionality, and content
» Outreach and launch strategy
» Business model/sustainability strategy
» CRF license and terms of use agreements
Determine the composition of the committee and adopt a process
for replacing, adding, or removing members.
Set general policies and procedures for the use of the CRF Library.
Contribute and/or solicit contributions of CRFs to the library
The Steering Committee - Members
Volunteer members from OC users» Lori Brix – Silent Partners» Elisa Priest – Baylor Research Institute» Derek Wimmer – Wimmer Clinical» Liz Watts – Starfire Research
Akaza personnel» Cal Collins» Jeff Halperin» Ben Baumann» Alicia Goodwin» Alan Rubin
…Activities…
Regular meetings
» Telephone conferences
Discussions involving:» Objectives and focus
» Selection of standards
• CDASH
• NCI
» Processes for review
» CRF’s for development
» Supporting documentation
Review and Implementation cycle
How is it being implemented?
Step 1:
Selection of CRF standard
» CDASH_STD-1.0
» The aim of the Clinical Data Acquisition Standards Harmonization (CDASH)
Standard Version 1.0 is to describe recommended basic standards for the
collection of clinical trial data.
Using the documentation provided by CDISC CDASH Core and
Domain Teams of the CDASH Initiative the Domain selected is
studied and the appropriate variables selected for inclusion in
Generic Standard CRF’s within the OpenClinica Data Collection
System.
…
The CDASH Domains have been divided into different levels of
complexity according to the recommendations for use of the variable
structures.
CDASH uses 3 levels of variable usability (CDASH Core) –
» Highly recommended: A data collection field that should be on the CRF (e.g., a
regulatory requirement).
» Recommended/Conditional: A data collection field that should be collected on
the CRF for specific cases or to address TA requirements (may be recorded
elsewhere in the CRF or from other data collection sources).
» Optional: A data collection field that is available for use if needed.
Step 2:
CRF’s designed to comply with the CDASH recommendations AND to function within OpenClinica without compromising or altering the integrity of the CDASH domain variable structures.
Each CDASH Domain has multiple CRF versions based on configurations of the ‘core’ recommendations.
» Demographics Domain (DM) = 3 CRF’s
» Medical History Domain (MH) = 2 CRF’s
» Physical Examination Domain (PE) = 2 CRF’s
Configurations are determined by » Minimum requirements
» Maximum requirements
» Analysis requirements
» Committee expertise
Sample page #38 from CDASH document
Example 1 – DM001
Example 2 – DM002
Example 3 – DM003
Step 3:
Draft CRF reviewed by Steering Committee (SC)
Comments used to revise as appropriate
Updates reviewed by SC
Final CRF approved for release
Supporting documentation developed » Implementation guidelines
» CRF Completion Guidelines (CCG’s)
Screenshot for entry into CRF library
Monitoring and Maintenance
Once developed all CRF’s will be reviewed periodically to ensure
continued industry standard compliance
Updates will be implemented as appropriate due to new CDASH
versions
New versions and/or CRF’s will be developed and included
All supporting documentation will be updated to maintain continuity
Where does the Future Lie?
…
In the hands of you …
The
Users
Thank you
Liz Watts B.Sc. MICR
Starfire Research/Akaza Research
Liz.watts@starfire-research.com
780-922-5203
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