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