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Frequently Asked Questions Phasing Out TraIT OpenClinica

Deadline January 31st, 2022.

Question: When will support end?

Answer: The currently provided TraIT OpenClinica support / OpenClinica.nl will end in the coming 1-2 years (latest by January 31st, 2022). No new study requests are being accepted in TraIT OpenClinica since January 1st, 2020. For ongoing studies that require support beyond 2022, migration options and a plan to realize this transition will be discussed with you on an individual basis. For studies that have already ended or will end latest by January 31st, 2022, appropriate exiting and archiving options will be discussed with you accordingly.

Question: Why has this decision been taken?

Answer: 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 The investments in this OpenClinica version have declined over the recent years leaving us with a clearly outdated user interface which cannot meet the requirements and expectations of our users anymore.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.

Question: What other EDC alternatives are there?

Answer: There are several alternative EDCs available. If you are currently making use of the TraIT/Health-RI OpenClinica service, you will be contacted individually to assess the best alternative fitting your needs. Where possible, we will put you into contact with your local support office and we recommend that you make use of an EDC which is supported by your organization.

As a broad overview, the following EDCs are considered:

  •  OpenClinica 3.x - The Community Edition currently offered by TraIT/Health-RI (will be phased out latest by January 31st, 2022)
  • OpenClinica 4.x - The new cloud-based OpenClinica (paid version)
  • LibreClinica – Open source successor of OC using up to date components (fully compatible with OC 3.x)
  • Castor EDC - A popular Dutch solution, which is rapidly expanding internationally (paid version)
  • REDCap - A free (mostly) publicly available solution, which can be hosted on private hardware (license restrictions may apply when serving other institutions)
  • Alea - An EDC suitable for clinical trials, used, amongst others, by the NKI
  • De Research Manager - Dutch solution used, amongst others, by Isala Zwolle

Question: What should I do now?

Answer: In the coming months, we will reach out to all PIs of studies using the TraIT OpenClinica service to help identify the best follow-up solution and to realize the transition. Where needed, we will also work out bespoke transition solutions, if these are critically needed for a specific project. However, should you already have urgent questions, please do not hesitate to contact the TraIT/Health-RI Service Desk: servicedesk@health-ri.nl.

Question: How will I be assisted in this transition?

Answer: In the coming months we will reach out to you personally to help identify the best follow-up solution and to plan the transition. For studies running longer than January 31st, 2022 we will help you identify the best fitting alternative EDC based on your needs. We will put you in contact with the correct person for this transition (preferably your local support office). We will support you in choosing an alternative EDC, put you in contact with the corresponding alternative EDC service, and finally, we will support in the export of your study. Where needed, at an incurred cost, we can work out bespoke transition solutions, if these are critically needed for a specific project. We are unable to support the import of your study into an alternative EDC and/or the incurred costs of doing so.

Question: My study has already finished or will finish latest by January 31st, 2022- what should I do?

Answer: TraIT/Health-RI support for all studies continues latest until January 31st, 2022. Closed studies will be offered a data export of their study, including audit trail, notes and discrepancies. For studies ending latest by January 31st, 2022, transitioning to an alternative EDC will likely not be necessary, provided data does not need to remain available online for the years to follow. For studies needing data to remain online after January 31st, 2022, advise on archiving options and solutions can be provided. However, costs incurred for archiving and hosting after January 31st, 2022, will need to be covered by the project.

Question: What costs will I have to cover?

Answer: Support for ongoing TraIT OpenClinica studies will continue until latest January 31st, 2022. Our services and support will include assisting in the choice of an alternative EDC, making contact between you and your local support office/ or directly to alternative EDC, and finally, support for the export of your study. However, should you require more bespoke solutions, then these will be discussed on a case-to-case basis and may incur additional costs for your study.

Please keep in mind that most alternative EDC’s are commercial services and will therefore incur additional costs for your study. However, most organizations provide institutional licenses which can be used by researchers for their projects. We will assist you by putting you into contact with your local support office for further information regarding supported EDCs.

Question: Why does OpenClinica claim that it will continue support for the community edition?

Answer: 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.