Institute: Academic Medical Center (AMC), Amsterdam, The Netherlands
Department: Department of Anesthesiology
The Department of Anesthesiology in the Academic Medical Center (AMC) has a large number of research projects running. Although the sponsored studies usually have their own databases, the Department did not have a uniform database for investigator-initiated research. After the Joint Commission International (JCI) audit last year, the Department decided to investigate the different databases with an eye to standardizing usage within the Department. A number of databases were considered (Oracle, Open Clinica and Castor EDC). Amongst the criteria considered were data security requirements, cost, user friendliness, amount of time needed to build the database, long-term data storage and the types of studies that could be run, such as full-scale randomized controlled trials (RCTs), smaller observational studies and registries.
The Department came to the consensus that a departmental license would ensure that all research conducted would be GCP (Good Clinical Practice) compliant and comply with the data privacy laws surrounding private health information. Audit findings confirmed that Microsoft Excel, Google Sheets and Forms are not databases, the use of these applications for research purposes (i.e. the storage of research data) is not allowed in the Department. The inability to track changes and error proneness of Excel are major flaws. Data leakage, such as the improper transfer of patient health information between hospitals carries a hefty fine, a barrier resolved with Castor’s multicenter study functionality. Furthermore, using the right research tools ensure that the study is audit-proof and quality checked, which is important for research.
The benefit of Castor were that it checked all the boxes regarding the Department’s needs, as well as the fact that the costs are not prohibitive and enabled the researchers to follow their research goals.
When building an eCRF (electronic Case Report Form), it is important to plan the study, usually you start with an annotated CRF where all the logistics and organization of the steps, the dependencies and validations are all worked out. Within Castor it is also possible to import tried-and-tested eCRFs via Castor Form Exchange for time savings. The Department is also pleased with the ability to send surveys to patients, but GCP compliance was most important when selecting the system.
The kick-off training session given by Castor’s Customer Success Manager Lieke Helsper was successful and positive comments were heard from the department which has three studies built since. Very active in the research community, the Department of Anesthesiology has more studies in the works, including international registries. Castor is excited to see the publications from their research trials in the coming period and we wish them success!