Many people who work with EDC systems have heard of or been impacted by CDISC, Clinical Data Interchange Standards Consortium. CDISC’s mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. They have many different initiatives, but one of their newest ones promises to aid the development and use of electronic Case Report Forms (eCRFs), the foundation of an EDC system.
Clinical Data Acquisition Standards Harmonization, (CDASH) aims to standardize ways of collecting data in a clinical trial. The current EDC landscape has hundreds, even thousands, of different eCRFs that capture essentially the same information, but with CDASH’s initiative one common data element can be used for each piece of information collected.
The initiative is not being pushed to enforce the way an eCRF looks and feels; rather, it seeks to standardize the way the fields and data on a form map to a database. Allowing users to create eCRFs with one standard in mind will allow the users to re-use their work again and again rather than having to create new eCRFs the next time they begin a study.
By mapping OpenClinica CRFs to CDASH content standards (element name, definition, and the related metadata) users of OpenClinica can access a basic set of global data collection fields with semantics agreed upon by representatives from Contract Research Organizations (CROs), Academia, Government and Industry. These CRFs can be found in the OpenClinica Enterprise CRF Library.