CTU Bern (Clinical Trials Unit)

Data Management

The Data Management (DM) division at CTU Bern is supporting you during the creation of your study database. We are offering different models of service and support, depending on how much expertize there is in the study team:

Overview of CTU Bern Data Management Services

Full Services: CTU Bern sets up the entire study database for you

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Based on your specifications (study protocol, variable listing, draft case report forms), we perform the setup of the study database: We implement the eCRFs, edit-checks and visit structure in close collaboration with you, the study sponsor/PI. When the database is finalized, you perform a “user acceptance test” to confirm that CTU Bern has implemented the study database according to your specifications.

For Full Services, CTU Bern is using the web-based Clinical Data Management Systems (CDMS) REDCap and secuTrial. If you are not sure which one corresponds better to your needs, feel free to contact us for a free consulting.

REDCap Basic: You set up your own study database

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REDCap Basic is not provided anymore for new projects. It was replaced by REDCap Light (see below), which provides the study sponsor/PI with more rights to manage their study database.

REDCap Light: You manage your own study database

If you prefer to setup your study database on your own, visit our "REDCap Database Implementation" training. After this, you will have a basic knowledge on how to implement and manage your study database using our REDCap Light service:

We will create a REDCap project for you and provide you with our template eCRFs, standard roles as well as our User Manual for REDCap Light. You take care of the setup of your study database, the user/roles management as well as the database locking and archiving. If you wish, you can have your database reviewed by us before you start entering real data.

This services is only provided for REDCap.

Clinical Data Management Systems (CDMS)

All CDMS at CTU Bern are web-based. As an authorized user, you can therefore access your study database from any computer through a web-browser. Secure Sockets Layer (SSL) encryption ensures a secure internet connection.

CTU Bern offers with REDCap and secuTrial two CDM Systems, both of course GCP and HRA compliant. Your choice of the system used should depend on the complexity of the study design and your needs. The CTU Bern Data Management team is happy to help you choosing the right system for your study.

Infrastructure, Maintenance and Support

CTU Bern provides and maintains secure and up-to-date IT infrastructure. The servers that host the study databases are housed in dedicated server facilities at the University of Bern or at the Inselspital Bern. Together with our IT, we regularly update the CDMS as well as all other software on the servers. We regularly back up study- and meta-data, according to a detailed back-up plan. Internal back-ups are made several times per day and daily back-ups are stored on external disks.

Our security measures meet the standards of the “Datenschutzaufsichtsstelle des Kantons Bern”.

CTU Bern Data Management provides support during regular office hours (Monday to Friday, 9:00 to 17:00). For running study databases, please inform us at least 1 week in advance about the creation of new study centers. The creation of new logins will take us 0-3 working days, depending on the complexity of your study and the amount of logins requested.