OpenClinica Case Report Form Library Now Available

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New, freely available resource enhances clinical trial productivity for adopters of the OpenClinica open source electronic data capture system

The OpenClinica CRF Library is a unique resource that makes standardized eCRFs freely available to OpenClinica adopters.

Akaza Research announces the availability of the OpenClinica Case Report Form (CRF) Library. The CRF Library is a free, web-based resource that helps OpenClinica users find, share, and re-use clinical trial case report forms. It contains a collection of expert-reviewed CRFs based on CDASH standards, as well as a growing collection of CRFs contributed by members of the OpenClinica community and imported from open access repositories such as the National Cancer Institute's Cancer Data Standards Repository (caDSR).

“The OpenClinica CRF Library is a unique resource that makes standardized eCRFs freely available to OpenClinica adopters. It contains both highly curated CRFs which have been reviewed by a panel of domain experts, as well as a more diverse spectrum of CRFs contributed by members of the OpenClinica community,” said Cal Collins, CEO of Akaza Research, the organization sponsoring the CRF Library. “The Library will help drive quality and efficiency of clinical research with the OpenClinica open source electronic data capture system.”

The CRF Library is available at http://library.openclinica.org and free to community members with a http://www.openclinica.org login. Access to the Library is available at two levels: free community-level access, and enhanced enterprise-level access (which is included as part of an OpenClinica Enterprise Edition subscription). Enterprise-level access provides enhanced resources for certain CRFs, such as CRF completion guidelines, rules, and test scripts.

As a one-of-a-kind resource, the CRF Library:

  • Enables faster study startup by providing ready access to a well organized, searchable database of OpenClinica CRF templates
  • Promotes data standardization through re-use of CRFs that adhere to open industry standards
  • Minimizes time and cost spent on study training, testing, and validation through value-added resources and documentation (including implementation guides, CRF completion guidelines, and test scripts) associated with the CRF templates in the Library

Ben Baumann, Akaza’s Director of Business Development, noted that there has been a significant enthusiasm among OpenClinica community members to share CRFs they have developed. “Members of the OpenClinica community are encouraged to contribute to the CRF Library. By contributing, users can share CRFs with a worldwide audience of other users under open source licensing terms based on the Creative Commons license. Contributors benefit as users contribute back updated or adapted versions of those CRFs and share their feedback on usage and best practices.”

The OpenClinica CRF Library will continue to grow as more standards-based forms are reviewed and accessioned by the OpenClinica CRF Library Review Committee, and as contributors submit CRFs for inclusion in the Community collection.

About OpenClinica®

OpenClinica is open source, web-based clinical trials software for electronic data capture (EDC) and clinical data management (CDM). OpenClinica facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulator guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. OpenClinica’s open source pricing model facilities a dramatically lower cost of use and ownership than proprietary, closed EDC and data management systems. All versions of OpenClinica are available for free download from http://www.openclinica.org.

About Akaza Research®

Akaza Research, the leading provider of open source clinical trial software, is headquartered in Waltham, Massachusetts. Supported by the National Institutes of Health (NIH), Akaza has developed and commercialized OpenClinica, the he world’s most popular open source clinical research software. Akaza brings Open Source Software (OSS) into the mainstream of the clinical research enterprise by making robust, flexible, standards-based systems accessible for all types of clinical research. Akaza Research provides OpenClinica support, training, hosting and other value added services to its customers worldwide. See http://www.akazaresearch.com.

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Benjamin Baumann

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