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Keen Interest in OpenClinica

A first performed TMF-workshop on open source software OpenClinica encountered unexpectedly high response.

September 15, 2013. It became evident that the management of trial volunteer data with OpenClinica in Germany is much more widespread than expected and the existing expertise is far greater than expected. The aims of the workshop, which was jointly held by the TMF and the Institute of Medical Informatics, Statistics and Epidemiology (IMISE), Leipzig, in the meeting rooms of the TMF in Berlin on September 10, 2013, were to exchange experiences and establish a community of OpenClinica users.



Workshop leader Matthias Loebe (IMISE Leipzig) presented OpenClinica and pleaded for an active use and development of the system.

OpenClinica, which is free open-source software for the management of trial volunteer data within the scope of clinical research, is a low-cost alternative to commercial clinical data management systems. It is therefore being used more and more in academic research.

"As has become evident, there are initial experiences of OpenClinica at many locations throughout Germany and in some cases customizations and extensions have already been developed as well," said workshop leader Matthias Löbe from the IMISE Leipzig, summing up after the event. "To date, however, none of the around 70 registered participants had an overview of activities at other sites. The workshop here opened up a completely new perspective for everyone," Löbe explained with satisfaction.

TMF tools and concepts in use at many locations  

Within the scope of the presentations the IT infrastructures of the various sites were also presented. "It became evident that irrespective of TMF membership many sites now naturally refer to TMF concepts or directly employ TMF tools such as the PID Generator," commented Dr. Johannes Drepper, head of the department of IT Infrastructure, Quality Management and Data Protection at the TMF.

Users interested in establishing a community




Alicia Goodwin (OpenClinica LLC, Boston) marveled at the expertise existing in Germany concerning OpenClinica.
Unanimously the workshop participants said they were willing to make the self-acquired know-how and their own further developments available to the community and to also perform the required documentation.

The users also plan to continue the open and constructive discourse throughout the workshop on a regular basis in future. For the time being it remains undecided whether OpenClinica LLC will promote this soon by supporting regional user groups or whether a different form of organizational assistance will have to be found.  


  1. Full article on German newspage

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