Info

OpenClinica

OpenClinica is an electronic Clinical Research Form (eCRF) application, designed to capture clinical study data in a structured format.

 

The standard way to capture data in clinical studies is via Case Report Forms (CRF) which are specifically designed to collect study data in a structured format. The sponsor of the study is responsible for designing CRFs that accurately represent the protocol of the clinical study, as well as managing their production, monitoring data collection and auditing the content of the completed CRFs.

OpenClinica CRFs can be completed for all participating subjects and can be reached from various locations in the world, allowing OpenClinica to be used for multi-center studies.

Some features of OpenClinica:
  • Open Source license
  • Web based
  • Supports all types of clinical studies
  • No programming/ IT knowledge needed for CRF design
  • Built on leading, independent standards

 

TraIT hosts and supports two secure OpenClinica environments based which can be used by any Dutch initiated project, based on a fair use and freemium model:

  • A Sandbox environment that is used to build and test an OpenClinica study and CRF before starting actual data capture - sandbox.OpenClinica.nl
  • A Production environment used for studies for which data capture is on-going - OpenClinica.nl

 

To assist in management of data in OpenClinica, TraIT also provides the following other services around OpenClinica:

  • User support via a skilled service desk

  • OCDI - OpenClinica Data Importer, to enable data upload from other sources into OpenClinica

  • Rule Designer / Rule translator - to design complex rules and calculations in OpenClinica

  • Building Blocks - a library of standardized eCRFs to facilitate creation of study specific CRFs, promoting interoperability

  • FAQ pages

  • Support in building of enhanced eCRF forms (e.g. with Java-scripts)

  • Link to other data storage and analysis tools

  • SPSS and SAS exports

  • A user forum where users can ask questions, submit suggestions for improvements, and report issues.

  • OpenClinica training on demand

 

Current version and release notes

OpenClinica 3.6  (Release notes)
TraIT vOCDI_2.0.0