OpenClinica Features

OpenClinica is a freely available, open source web-based software platform for managing clinical research studies. It has features for protocol configuration, design of Case Report Forms (CRFs), Electronic Data Capture (EDC), retrieval, and clinical data management. OpenClinica is designed to support regulatory guidelines such as 21 CFR Part 11, and is built on a modern architecture using leading standards.

The main functionality includes:

• Submit Data: Allows subject enrollment, data submission and validation for use by clinicians and research associates as well as Query Management and Bulk Data Import.

• Monitor and Manage Data: Enables ongoing data management and monitoring.

• Extract Data: Enables data extraction and filtering of datasets for use by investigators and principal investigators.

• Study Build: Facilitates creation and management of studies (protocols), sites, CRFs, users and study event definitions by principal investigators and coordinators.

• Administration: Allows overall system oversight, auditing, configuration, and reporting by administrators.

(example screen showing source data verification)

Additional features include:

• Organization of clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs. Support for sharing resources across studies in a secure and transparent manner.

• Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters and validation logic specified in portable Excel templates.

• Management of longitudinal data for complex and recurring patient visits.

• Data import/export tools for migration of clinical datasets in excel spreadsheets, local databases and legacy data formats.

• Extensive interfaces for data query and retrieval across subjects, time, and clinical parameters, with dataset export in common file formats such as tab-delimited, SPSS, and CDISC ODM XML.

• Enables compliance with regulatory guidelines such as 21 CFR Part 11. Features include differentiated user roles and privileges, password and user authentication security, electronic signatures, SSL encryption, deidentification of Protected Health Information (PHI), and comprehensive auditing to record and monitor access and data changes.

• A robust and scalable technology infrastructure developed using the Java J2EE framework interoperable with relational databases including PostgreSQL (open source) and Oracle 10G, to support diverse clinical trial IT environments.

Learn more about OpenClinica's current capabilities on the OpenClinica wiki.

Related Pages

	Title	Date	Posted By
	OpenClinica Software Architecture	Oct 19, 2009	ccollins
	OpenClinica LGPL Software License	Apr 06, 2009	ccollins
	OpenClinica Preview Screens	May 05, 2008	ccollins