The Data Management (DM) workflow at CTU Bern offers two different models of service and support for the setup of a clinical study database or datamanagement system:
CTU Bern sets up the entire study database
Based on your paper case report forms (CRFs) or your study specifications (list of CRFs, variables etc.), CTU Bern set up of the database (eCRFs, edit-checks, visit structure) using one of its two web-based Electronic Data Capturing (EDC) solutions REDCap or secuTrial. When the database is created, you perform a “user acceptance test” to affirm that CTU Bern has implemented the study database to your specifications.
If you prefer to setup your study database yourself, we provide an introduction to our EDC system REDCap. You can then set up your study (eCRFs, edit-checks, visit structure) by yourself. CTU Bern will provide as much support as you request. When you completed the set up CTU Bern will review your implementation and activate the database, so that you can begin data-entry.
Electronic Data Capturing (EDC) Solutions
All EDC systems at CTU Bern are web-based. Authorized users can access the study database from any computer with an internet connection and web-browser. Secure Sockets Layer (SSL) encryption ensures a secure internet connection.
CTU Bern offers two GCP-compliant EDC solutions. Your choice should depend on the complexity of the study design and your needs.
Infrastructure, Maintenance and Support
CTU Bern provides and maintains secure and up-to-date IT infrastructure. The servers that host study databases are housed in a dedicated server facility at the Institute of Social and Preventive Medicine at the University of Bern. Our servers are secured behind a firewall and we have a 24x7 maintenance agreement with our supplier, so that problems with hardware can be fixed quickly. Our Data Management team regularly updates all 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 for the EDC systems during regular office hours (9:00 to 17:00). Need for additional support needs to be discussed on a case-by-case basis.