OpenClinica is an open source secure clinical trials electronic data capture and management system which is accesible via the NBIP Ireland moodle site. The system allows for the highest standards of European regulatory compliance for running human clinical trials due to the oversight, auditing and reporting abilities. It is especially useful when a study is being carried out in mulitple sites.
The person collecting the data can go on any computer with internet access, log in to the system and be directed to their particular study where they can enter patient data. The data can then be accessed by the principal investigator in charge of the study, exported to a data analysis program and analyzed. The investigator can also keep track of how each site is doing. Each study has its own set of electronic data forms. These forms are made using Excel and uploaded to the site. Please note that Mary De Voe (UCC) has already developed some templates which can be amended to meet a study's requirements.
Each person accessing OpenClinica has a unique username and password that is assigned by a study administrator and each user is assigned privileges depending on what their role in the study is.
For NBIP Ireland in particular, this program provides some of the infrastructure that will facilitate collaborative imaging studies that involve collection of patient data across institutions. It will allow for regulatory-compliant collection of human data. This does not preclude its use in translational studies too. Please note that this software can also be used for cataloging clincal sample storage. To access software click here
Contact Person: Mary DeVoe