Info

Our Ldot services

 

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

User support

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

There are manuals and guidance documents available in the TraIT servicedesk (for the time being only in Dutch). All users of TraIT applications receive a user account for TraIT servicedesk.

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 were initially covered by TraIT. In the current production phase, research projects can use the TraIT Ldot server at a fee (please contact the service desk for more information), with a fair-use policy. A regular study meets the following requirements:

  • A maximum of 6 hours support are included for each study schedule
  • Each study schedule is allowed to have a maximum of 20 users
  • Each study schedule is allowed to have a maximum of 2000 subjects
  • Study schedules which are expected to exceed a total of 10.000 subjects will have to contact Service Desk to analyse possibilities

Projects having extraordinary demands with respect to computing capacity, disc space or network bandwidth should fund this extra from their own project budget

 

Tailored support

The learning curve for using Ldot can be steep and it might not be suitable for a single-time usage scenario. Therefore, it is a possibility to let professional data managers build the schedule for you. Contact TraIT service desk or MEMIC directly should you desire more information on this topic. Also, Ldot can be tailored to your needs. This may mean, however, that your study can not be hosted within the Generic Trait Ldot solution. Please contact the TraIT service desk or MEMIC directly if you have a specific request.

 

Links to other data storage and analysis tools

The 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 created 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.

Data storage in other TraIT application may be linked to actions in Ldot. For example, if a study action is completed in Ldot, for example a CT scan is performed, the scan date can be send to the OpenClinica CRF. TraIT and MEMIC are currently in the process of developing a standard tool for two-way communication between Ldot and OpenClinica. MEMIC also supports communication with other in-house developed or third party applications (such as their own internet questionnaire, Castor EDC, Qualtrics and NBIA). Please contact the TraIT service desk for more information on this topic.

 

Data security and integrity

To ensure data security, all data is stored in a ISO27001 certified environment, in an Oracle database. All data is backed up daily and hourly, so that in case of any calamity (or disaster), data can be restored easily to a recent time point. Backups are stored in a physically different location. MEMIC has a Data Processing Agreement with all parties who have access to their database to ensure the privacy of all subjects stored in the database. Furthermore, all personal data (i.e. name and contact details) are stored separately from research data, in line with the Dutch privacy law WBP (Wet Bescherming Persoonsgegevens), the European GDPR which will replace the dutch WBP as from May 2018, and GCP guidelines (Good Clinical Practice). All data managers employed by MEMIC are GCP-certified and are bound non-disclosure agreement (NDA). If desired, a project specific NDA may be drawn up.

All software developed by MEMIC is secured by strict user management. Each application has its own user scheme. All passwords are encrypted with multiple encryption methods and passwords are bound to a minimum set of requirements of used characters (differentiated between lower case, upper case, special characters and numbers) and minimum length. Furthermore, if desired by the client, passwords must be altered every X months. To further ensure data security, every application user is a member of a certain membership role. A membership role may or may not have access to specific application sections (i.e. personal data, action dates). A user can furthermore be bound to a specific location or study centre, to ensure that this user does not have access to other location or study centre data; For example, in a multicentre study performed within two hospitals, a user appointed to the first hospital will not see personal data of patients enrolled in the second hospital.

Ldot can only be reached over a secured Hypertext Transfer Protocol Secure connection (HTTPS). This means that all data that are exchanged between the clients and the server will be sent encrypted over the Internet. In order to block access from unauthorized locations, application access can be restricted to specific Internet Protocol addresses (IP-addresses; a way to identify the location of the web device connecting to the web application).

 

Application and Change Management

MEMIC technical support staff is responsible for application management. Application changes (such as upgrades) are tested by TraIT-MEMIC staff on a test server and on an acceptance server. Only after successful tests the change will be performed on the production server by TraIT-MEMIC staff.