What is happening in the development initiative: National data collection system
Ingrid Sandgren has been project manager for the development initiative National data collection system. In the interview below, she explains what the project resulted in and what happens next.
Why did we invest in an initiative on a national data collection system?
The reason for the initiative was a national interest in a common Electronic Data Capture (EDC) System for academic studies. The nodes offer different types of systems and services for data management and data collection in clinical studies, but as the researchers' needs and data quality requirements are the same regardless of region, the project was assigned to investigate the harmonization of operating modes for some common support functions.
What was the result of the development initiative?
It was clear early on that a national procurement for a central operating function is not possible under the Public Procurement Act (LOU; 2016: 1145). On the other hand, it is possible to make a coordinated tender between interested nodes. Within the project, we have developed a URS, User Requirement Specification, and an RFI, Request for Information, which can be used as a basis for future procurement of EDC systems.
In order to create conditions for harmonization as well as to implement and further develop the delivery of the initiative, we recommend that a data management network be started within the nodes of Clinical Studies Sweden. The network should work together on processes, documentation, support for local education and data management support.
We identified a distinct need for the data management in clinical studies to be as close to the investigator as possible, and there are arguments in favour of a regional or local organization. The project therefore recommends that all nodes aim to establish a "basic level" in order to harmonize data management services. During the build-up phase, nodes with more experience can support other nodes.
The project also had the task of investigating the possibility of a national randomization service. The conclusion is that several of the nodes already use EDC systems where the randomization service is included, and for others there are several available web solutions.
In order to strengthen information security in academic clinical studies, there is a need to conduct a generic risk analysis process for information management, and file transfer for sensitive data should be encrypted.
What happens next?
The results of the project were presented to the node managers in May 2018, and discussions on how to manage the results are currently under way.