TraIT OpenClinica End of Service 

In 2018-2019, the TraIT team thoroughly reviewed all applications  implemented and maintained by TraIT over the past eight years to support the entire translational research process across the various TraIT data domains. With respect to the electronic data capture domain, this in-depth evaluation  led us to the very unfortunate conclusion that TraIT OpenClinica will be phased out and decommission entirely by January 31^st, 2022.. As a logical consequence, no new OpenClinica studies are  accepted as of January 1^st, 2020.

This announcement, together with a similar announcement for the TraIT tranSMART service, completed the evaluation of the TraIT suite of tools. The remaining TraIT services, such as XNAT, CTP, cBioPortal, Ldot, and the biosample Catalogue, will remain actively supported, and are considered to be sustainable for the foreseeable future. Moreover, the TraIT Servicedesk, quality management system, and Data Processing Agreements remain in place under full responsibility of Health-RI.

The decommissioning of the currently provided TraIT OpenClinica service should not be interpreted as a refusal by Health-RI to host such centralized EDC services in the future if the need for such a centralized EDC service re-arises and alternatives are not deemed sufficient. At this time however, the TraIT/Health-RI strategy will be to facilitate access to, and operability with, the alternative EDC tools through the Health-RI portal. This includes integration with other Health-RI solutions such as XNAT.

The currently provided TraIT OpenClinica support / OpenClinica.nl will end latest by January 31^st, 2022. TraIT OpenClinica will be turned off and all studies will be removed on January 31^st, 2022 No new study requests are being accepted in TraIT OpenClinica since January 1^st, 2020. All studies making use of TraIT OpenClinica will either need to be archived or migrated to an alternative EDC. All studies must have completed migration or archiving no later than December 1^st, 2021.

There are several developments that have prompted this decision:

• The OpenClinica open-source edition used by TraIT (and 100s of organizations across the world) has always been maintained and distributed by a commercial organization, OpenClinica.com. The investments in this OpenClinica version have declined over the recent years leaving us with a clearly outdated user interface which cannot meet the requirements and expectations of our users anymore. This has also been demonstrated by a steady decline of OpenClinica usage in favour of competitive solutions such as Castor.
• The company OpenClinica.com has decided to maintain the open-source version of the OpenClinica software with low priority only.  The company focus is now on an entirely new, cloud-based commercial solution. Considering that there will be few updates, including security patches, TraIT will not be able to ascertain security and quality on the longer term.
• At the time that the TraIT tool suite was launched, there was limited access to electronic data capture tools for researchers outside the clinical trial domain, whereas there was evidently a need. The TraIT OpenClinica service has been very successful in filling that gap. Over the last couple of years, the availability of such tools, e.g. Castor and REDCap, has substantially improved, in particular, as a result of investments in data stewardship support from individual research institutions. Consequently, large parts of the Dutch research community are already served by one of these solutions leaving less need for an independently maintained TraIT/Health-RI solution.

Based on lessons learnt and experience gathered, Health-RI has set up an overview of alternative EDC’s, including a new option to migrate to LibreClinica, hosted centrally by Health-RI (see also letter to clients)

As the PI of a TraIT OpenClinica study, you must inform the Health-RI ServiceDesk via email using the following procedure template latest by September, 30^th, 2021 whether you will: 

• Archive (support via local support office at leading institute)  
• Migrate to Castor (support via local support office at leading institute) 
• Migrate to REDcap/other EDC (support via local support office at leading institute) 
• Migrate to LibreClinica (support offered by Health-RI at cost, see attachment) 

If you are unsure about the contact details of your local support office, please contact the Health-RI ServiceDesk for more information. All studies must have completed migration or archiving no later than December 1^st, 2021 

• Archive (support via local support office at leading institute)  
• Migrate to Castor (support via local support office at leading institute) 
• Migrate to REDcap/other EDC (support via local support office at leading institute) 
• Migrate to LibreClinica (support offered by Health-RI at cost, see letter to clients) 

See letter to clients for more detailed information.

Your study will need to be exported for archiving at your local institute. Please consult your local support office for advice and follow instructions outlined in the procedure template for archiving.

Please keep in mind that most alternative EDC’s are commercial services and will therefore incur additional costs for your study. However, most UMC’s provide institutional licenses which can be used by researchers for their projects at a decreased price. See letter to clients for more detailed information, including costs for centrally hosted Health-RI LibreClinica service.

Although OpenClinica.com officially continues support for its OpenClinica 3.x Open Source version, the company has strongly focused its efforts on the new 4.x paid version. In recent years, investments and improvements in the Open Source version used by TraIT (and 100’s of organizations across the world) has been minimal. With limited further improvements, lack of new updates (including security patches), we are left with a clearly outdated user interface which cannot meet the requirements and expectations of our users anymore nor can we ascertain security and quality on the longer term.