IDEAL develops an interoperable, secure and legally compliant solution to link patient-identifying data from health care providers with pseudonymized health-related data used for research.
To achieve this goal IDEAL aims:
- To develop a solution to link patient information from different source systems, the ID Mapping
- To provide a user-friendly system to securely handle patient identifying data in clinical research studies, the electronic subject-specific study log files
- To establish a national data center for coordination and handling of metadata and hashed patient information, the National IDEAL Data Center (NIDC)
According to the Human Research Act and its ordinance (HRA and HRO), health-related personal data must be pseudonymized or encoded before being used for research. This means that in a clinical dataset or a biological material sample, the reference to the person must be replaced by a study identifier. In order to ensure pseudonymization, the federal law and the Guidelines of Good Clinical Practice (GCP) stipulate that the personal identifying data (i.a. name, date of birth, address) must be stored in a system separate from the research database. This legal requirement often leads to organizational and technical hurdles, which IDEAL aims to overcome.
IDEAL will set up a database system, which connects the patient identifying information from the clinical data warehouse with the clinical research databases.
The core information is stored in the IDEAL linkage database, where every study participant is linked with the patient identifier from the hospital.
To overcome data protection issues, the linkage information, including patient identifying information and the research study identifier is exclusively stored at the patients treating institution. The proposed solution is decentralized, no identifying information is stored outside the hospital.
The suggested database structure and technical solution is the foundation to extract data for clinical research from the clinical dataware house in a highly efficient and secure manner.
Electronic subject-specific study log files
With the same operation, IDEAL provides a standardized digitalized solution to manage the screening/enrolment log and the subject identification log for any research study involving humans. These two documents are requested by GCP and the Swiss legislation and include the following information:
Besides the back-end solution, IDEAL provides a self-explaining user interface to manage the information needed for the log files and an option to extract the information.
National IDEAL Data Center (NIDC)
IDEAL is setting up the national IDEAL data center (NIDC). The NIDC is a national, centralized server platform that connects the IDEAL clients across all study sites. The NIDC provides the following functionalities:
- A central tool to distribute the IDEAL software applications within the connected network of all IDEAL clients
- Hosting of the IDEAL’s metadata repository
- Given the applicable law and regulations, the NIDC provides a National Directory of Study Participants, showing which hospital or healthcare provider has included which patients in which studies.
- Given the approved SPHN data governance structure and FAIR principles, the NIDC supports the management of requests from users who intend to link research data and routine hospital data.
The NIDC database stores a minimal set of data. It includes a hashed patient identification number to identify identical individuals participating in several studies. This national database does not include any identifying information.