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Our OpenClinica services

Some features of TraIT OpenClinica and description of the TraIT OpenClinica services.

User support

The CTMM-TraIT project supports users in the TraIT-OpenClinica environments. The TraIT servicedesk can be contacted for creation of user accounts on one of the environments, creation of a new OpenClinica study, and questions/problems related to the OpenClinica software.

There are manuals, guidance documents and how to’s available in the TraIT servicedesk. All users of TraIT applications receive a user account for TraIT servicedesk. Each OpenClinica CRF template is stored in a library on the server available for others to reuse. Since there are many CRFs that are already more or less standard it becomes easier to build a study by using CRFs in the library.

Please read more under User Support & Contact.

Please read the following section for more information on Conditions for use.

 

Pricing model

Costs of hosting and user support are currently covered by the CTMM-TraIT project. Research projects can use the TraIT OpenClinica server free of charge until (at least) January 2017. However a fair-use policy applies: Projects having extraordinary demands with respect to computing capacity, disc space or network bandwidth should fund this from their own project budget

Currently a business model is developed for the period TraIT funding is no longer available (starting January 2017). This model will be published by the end of this year.

 

Multi center access

The TraIT OpenClinica environments are accessible via the internet from all over the world. Therefore it is possible to capture data from different centers for one study in this OpenClinica environment.

 

Links to other data storage and analysis tools

The CTMM Translational Research IT (TraIT) project is developing a long-lasting IT infrastructure for the Netherlands that facilitates the collection, storage, analysis, archiving and securing of the data generated in investigator-driven biomedical research projects.

The TraIT services go well beyond the basic hosting of a set of tools. The project  is creating an integrated IT platform that will help to accelerate translational research: link results of basic biomedical research to (the variation in) patient’s symptoms or clinical outcome to enable development of new diagnostic methods or therapies to be used in clinical care.

One of the pivotal TraIT solutions is the central data warehouse TranSMART, which is also an open-source solution. Data captured and stored in OpenClinica as well as in other TraIT databases, can be loaded into this online environment. A user-friendly interface ensures that researchers can query the data collection using the tools of their choice allowing to integrate and analyse case report data, imaging data, experimental data and biobanking information.

TraIT also aims to develop data registration links with important data sources, such as hospital systems and large registries. A proof-of-concept project was performed which demonstrated it is technically feasible to upload data from a hospital source system into OpenClinica. Currently we are working on realization of such links for use in studies for which data collection is ongoing.

 

Compliance to rules and regulations

The OpenClinica Enterprise Edition is trusted worldwide to power mission critical clinical trials in highly regulated environments. It is developed according to a robust Quality System consisting of procedures, controls, and documentation based on ISO standards and aligned with FDA, GCP, and ICH regulations and guidance. The OpenClinica Enterprise Quality System is regularly audited by sponsors and CROs performing clinical trials regulated by the FDA and other regulatory bodies. The TraIT OpenClinica Community Edition does not have the procedures, controls and documentation in place that are required for FDA approval of pharmaceutical products and medical devices. However, the software codes of the Enterprise and Community Editions are the same (apart from the modules that are only present in the Enterprise Edition) and the OpenClinica Community Edition application complies to GCP regulations.

 

Security

TraIT OpenClinica has taken a number of security measures. We use standardized TraIT procedures (SOPs) for creating new user accounts in order to comply to the data owner’s instruction and to prevent unauthorized access to study data. The TraIT OpenClinica environments are hosted by Vancis (www.vancis.nl). Vancis possesses the NICTIZ certificate and meets the ISO 27001 standard for information security management. The network communication with the TraIT OpenClinica web-application is secured via the HTTPS protocol. We have a GlobalSign Extended Validation CA-G2 certificate that guarantees that the TraIT OpenClinica user is really communicating with the TraIT OpenClinica environment. Our infrastructure architecture has been optimized for data security; for example separate compartments are used for the web-, application and database servers. The OpenClinica database is backed up every night and every other year we perform a disaster recovery test.

OpenClinica takes security seriously at the application level. It works with controlled access through user accounts and authorization at the study and role level. For more information about the OpenClinica application please see www.openclinica.org.

The data owner, generally the sponsor of the research project, decides who gets access to the study in OpenClinica and indicates the role/authorization that should be applied to the user account. The institute or investigator that supplies the data to OpenClinica remains the owner of the data and access to the data is controlled by the owner. In order to comply to privacy regulations it is only allowed to store anonymized or pseudonymized data on the TraIT OpenClinica server.

 

Application and Change Management

TraIT technical support staff is responsible for application management. Application changes (such as upgrades) are tested by TraIT technical staff on a test server and clear instructions how to perform the change are provided to Vancis. Vancis always first performs the change on an acceptance server and after verification by TraIT personnel the change will be performed on the production server by Vancis.

All changes in the application are logged in TraIT logs. OpenClinica versions are synchronized kept between all (development/test/production) environments.

 

Large TraIT OpenClinica user community

Since OpenClinica was adopted by TraIT as the preferred data capture tool in 2011, its user base on the TraIT server has grown from 15 clinical studies to over 120 clinical studies involving more than 500 users.