OpenClinica

OpenClinica

Developer(s)	OpenClinica Developer Community
Initial release	December 23, 2005 (2005-12-23) (1.0.0)
Stable release	3.17.0  (August 31, 2023 (2023-08-31)) [±]
Preview release	none [±]
Written in	Java
Operating system	Cross-platform
Type	Laboratory informatics software
License(s)	GNU Lesser General Public License
Website	openclinica.com

OpenClinica is free open-source clinical trials software that allows for the creation of studies and electronic case report forms as well as the capture and management of clinical data.

Product history

OpenClinica has its roots in Akaza Research, Inc., a bioinformatics company that began as a startup idea around 2004 and as an official business in May 2005. By then it had already released a beta preview release and was eying a June 2005 release of an official version 1.0 of their software, dubbed OpenClinica. Akaza's founders had collaborated with Mass General Hospital, the University of Connecticut, and Stanford University as early as two years prior after recognizing "the need to create an affordable, secure, and flexible software platform for conducting multi-site studies or protocols in diverse clinical research domains." Version 1.0 finally arrived on December 23, 2005, featuring improvements over its beta including a better interface, better documentation, and more robust querying tools. Five months later the company announced 1,000 copies of the free open-source application had been downloaded, growing to 3,000 by early November.

On November 15, 2006, version 2.0 was released, including upgrades to the software's data capture, study design and management, usability, and security features. By October 2008, Akaza was firmly extending its reach beyond the development of its software and into the fields of service and support, gaining official licensing as a National Cancer Institute support service provider for caBIG-related software, documentation, and training materials. A year later version 3.0 of OpenClinica was released, touted as an example of "how an open source community can produce superior software." In July 2010, Akaza announced its open-source community had surpassed 10,000 members while at the same time praising the open-source model, stating it "helps ensure that the product [OpenClinica] is well aligned with users' real-world needs."

On June 29, 2012, Akaza Research legally changed its name to OpenClinica, LLC, though the company had been using the new name as early as the year previous.

For full release version history, refer to the project's list of project releases.

Features

Features of OpenClinica include:

• create studies/projects
• clinical data capture, normalization, and validation
• query management
• role-based security
• administrative tools
• reporting
• secure data sharing
• automated and manual data interchange
• follows 21 CFR Part 11 guidelines
• modular and extensible

Hardware/software requirements

Refer to the following:

• Installing OpenClinica on Linux Systems
• Installing OpenClinica on Windows Systems

Videos, screenshots, and other media

• Demo video
• Additional videos
• Self-guided demo

Training resources

Click2eLearn

Click2eLearn is a privately owned company offering high-quality and low-cost web-based training and tutorials for primarily open-source software platforms. The company offers 200 tutorials on the open-source clinical trials application OpenClinica. Training plans begin at $35 per month. Tutorials are broken down into 10 categories:

Free Overview and Concepts - This section contains four free tutorials that demonstrate some of the basic operational possibilities of OpenClinica.

1. Getting Started: Overview - These related tutorials focus on the architecture of OpenClinica, including the home page and role-based user interfaces.
2. Operations: Submit Data - These tutorials heavily focus on entering, importing, and modifying, and removing data in OpenClinica's various modules.
3. Operations: Monitor and Manage Data - These tutorials explain the various factors involved in managing and monitoring data and its access in OpenClinica.
4. Data Interchange: Extract Data - This series of tutorials explains in-depth how to set up, organize, manage, and transfer datasets in OpenClinica.
5. Configuration: Study Setup - The tutorials in this section cover how to set up and manage all aspects of a study.
6. Configuration: Rules - These related tutorials introduce the concept of rules in OpenClinica and how to create, manage, and apply them.
7. Security: Users and Roles - These tutorials cover the concept of user types and roles and how to assign them in OpenClinica.
8. Administration: Admin Areas and Activities - These tutorials explain all of the administrator functions of OpenClinica.
9. Setup: Installation and Upgrades - This section contains tutorials concerning how to set up a database for OpenClinica and install and upgrade it in either a Linux or Windows environment.

Further reading

• Franklin, Joshua D.; Guidry, Alicia; Brinkley, James F. (December 2011). "A partnership approach for Electronic Data Capture in small-scale clinical trials". Journal of Biomedical Informatics 44 (1): S103–S108. doi:10.1016/j.jbi.2011.05.008. http://www.sciencedirect.com/science/article/pii/S1532046411000992. 

External links

• OpenClinica blog
• OpenClinica developer wiki