HIPAA News

Akaza Research Launches OpenClinica Enterprise CRF Library, a Curated Web-Based Repository of Standards-Based Electronic CRFs

(Jan 23, 2008)-- Akaza Research announced the availability of the OpenClinica EnterpriseTM CRF Library, a curated web-based repository of standards-based electronic case report forms (eCRFs). The OpenClinica Enterprise CRF Library can dramatically enhance the productivity of clinical research operations:

* Enables faster study startup via access to a well organized, searchable, online database of OpenClinica CRF templates
* Promotes standardization of data through re-use of CRFs that adhere to open industry standards
* Facilitates rapid CRF creation by providing a large number of easily customizable CRF templates
* Minimizes the time and cost spent on study training and validation by leveraging key documentation associated with the CRF templates in the library (including requirements and test scripts)

The Library is searchable by keyword and browseable by specific research domains. Most CRFs are derived from authoritative, public standards sources such as the CDISC Clinical Data Acquisition Standards Harmonization (CDASH) initiative and the National Cancer Institute's Cancer Data Standards Repository (caDSR).

Planning, creating, and validating CRFs can be time consuming, costly, and risky. The Enterprise CRF Library reduces the time, cost, and risk associated with this work
"The OpenClinica Enterprise CRF Library presents a tremendous asset for the OpenClinica community," said Cal Collins, CEO of Akaza Research. "Planning, creating, and validating CRFs can be time consuming, costly, and risky. The Enterprise CRF Library reduces the time, cost, and risk associated with this work," he added.

By mapping OpenClinica CRFs to CDASH content standards (element name, definition, and related metadata) users of OpenClinica can access a broad set of global data collection fields with semantics agreed upon by representatives from Contract Research Organizations (CROs), Academia, Government and Industry. Incorporation of CRFs from the National Cancer Institute's Cancer Data Standards Repository (caDSR) includes reference metadata from source documents, such as (in the case of NCI CRFs) Common Data Element identifiers for improved data integration and ability to meet standardized reporting requirements. Additional standardized CRFs in other research domains will be made available over time.

OpenClinica is open source web-based electronic data capture software for clinical research. It facilitates protocol configuration, design of case report forms, clinical data capture, and study/data management. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a lightweight, standards-based, extensible, and modular platform.

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