In human research studies, it is legally required to store person identifiable data in a system separate from the research database. Study participants are usually pseudonymized in the research database and the study personnel keeps a protocol to ensure the link between the research data and the individual (“subject-identification log/code list”). A professional solution for this code list is often missing. Sometimes the code lists are even done on paper.
IDEAL is a national IT infrastructure project supported by the Swiss Personalized Health Network (SPHN)/Swiss Institute of Bioinformatics (SIB), which aims to provide for Swiss data controllers (e.g. hospitals) a decentralized, secure, uniform and therefore professional solution to support the management of person identifiable data in human research studies according to the Swiss regulatory requirements in human research.
IDEAL team developed a software, which allows to link pseudonymized codes of the study subject in the research database with the natural identity of the corresponding patient in the hospital (ID mapping).
IDEAL fulfills not only the regulatory requirements for the subject identification, but also builds the basis for the automated integration of routine clinical data from the hospital (e.g. clinical data, lab values, imaging or pathology) in the cohort/registry databases (or any human research study) throughout Switzerland. Today, data entry is often done manually.
In summary, IDEAL offers a service to professionalize the patient management in human research studies and is an important first step for clinical studies (i.p. for cohorts and registries) towards automated extraction of clinical routine data.
