The Academisch Medisch Centrum (Academic Medical Center of the University of Amsterdam), Department of Anesthesiology manages various forms of anesthesia, pain relief and intensive care related to patient operations, examinations, and treatments. They conduct extensive research in this area and were looking for a secure, user-friendly tool that could support their research initiatives and increase study efficiency.
Fulfilling research and data security requirements
Moving away from paper and Excel
Securely capturing high-quality data
Challenge: Fulfilling all the research and data security requirements
As an MPA (Masters of Physician Assistant) and researcher at the AMC and the Diakonessenhuis in Utrecht, Jennifer Breel has extensive knowledge of all the nuts and bolts of the research process. Using an electronic data capture platform wasn’t a new idea for her. She had been using Oracle Clinical and OpenClinica for research and is familiar with the highest degree of research compliance following audits by the Joint Commission International (JCI).
Jennifer was looking for EDC alternatives when she stumbled upon Castor EDC. The biggest challenge she wanted to solve was to efficiently fulfill all research and data security requirements. She found Castor EDC to be both cost and time-effective, especially since they were conducting extensive, long-running studies that would require numerous hours to build.Our Security Statement
Solution: Excel just wasn’t excellent enough
AMC decided that a departmental license would ensure that all research conducted would be compliant with GCP (Good Clinical Practice), and adhere to data privacy laws surrounding private health information. Jennifer explained that Microsoft Excel and Google Sheets are definitely not suitable for medical research due to the complete lack of data security. In fact, she believes that the use of these applications should be prohibited for research purposes (ie. the storage of research data).
Another major flaw in Excel and other spreadsheet systems is the inability to track data changes and errors. Data leakage, like an incorrect transfer of patient health information between hospitals, can have dire consequences including a massive fine. Such barriers in handling personal and sensitive patient data have been solved with Castor EDC’s granular audit logging.
All-in-all, using a tool that is secure and compliant such as Castor EDC ensures that the study is audit-proof and contains high-quality data.4 reasons to have a single EDC system
Castor EDC checked all the required boxes: GCP compliant, user-friendly, time-saver, audit trail.
Result: End-to-end data solution for all studies
The benefit of Castor EDC, explained Jennifer, is that researchers can run full-scale randomized controlled trials (RCTs), smaller observational studies, and registries all in one platform. Researchers don’t require any technical training, enabling researchers to easily achieve their goals.
When building the CRF, Jennifer follows a process of starting with an annotated form where she works out all the logistics, organizes the steps, and enables the dependencies and validations. This is an important step in planning a study after which you can easily import the CRFs via Castor Form Exchange. The flexible form builder in Castor EDC makes the eCRFs construction exceedingly simple. Jennifer also shared that Castor ePRO makes sending surveys to patients super easy and is a great administrative feature. However, GCP compliance was the factor that immediately tipped the scales in Castor EDC’s favor.Explore all Castor Features
Training and lift-off
The kick-off training session hosted by Castor EDC’s Lieke Helsper was successful and the department has since built 21 studies on Castor EDC. Being very active in the research community, the Department of Anesthesiology has more studies in the works, including international registries. Castor EDC is excited to see the publications from their research trials in the coming months!