Pharmacoepidemiological research is predominantly conducted on the basis of large routine databases (secondary data). These databases facilitate the investigation of the utilization and safety of drugs, including vaccines, in real-world healthcare settings and the investigation of rare or delayed adverse events. In so-called PAS studies (Post-Approval Safety Studies), these databases are used to investigate the utilization and safety of newly approved drugs. They also provide important data for research on other healthcare services. Since 2004, BIPS has been working on the establishment and maintenance of the German Pharmacoepidemiological Research Database (short GePaRD). GePaRD is based on claims data from four statutory health insurance (SHI) providers in Germany and currently includes information on approximately 25 million persons who have been insured with one of the participating providers since 2004 or later. In addition to demographic data, GePaRD contains information on drug dispensations as well as outpatient (i.e., from general practitioners and specialists) and inpatient services and diagnoses. Per data year, there is information on approximately 20% of the general population and all geographical regions of Germany are represented.
Using the database for research projects
Access to the database is granted only to BIPS employees within the framework of officially approved research projects. It is only permitted to give third parties access to the data in cooperation with BIPS and after signing an agreement for visiting scientists. Project approval is based on the authorization by the SHI providers and the respective governing authorities (e.g., the Federal Office for Social Security for national SHI providers). For this purpose, BIPS applies for project-specific permits from the SHI providers. Upon approval, the SHI provider requests official project approval from the governing authority. This may be issued in accordance with Section 75 of the German Social Code (SGB) X if the interest warranting protection of the person concerned is not affected or if the public interest in the research or planning significantly outweighs the interest in personal privacy. The process of approval by the SHI providers and the respective governing authorities may take several months.
The Pharmacoepidemiological Research Database GePaRD was provisionally accredited by the German Council for Social and Economic Data (Rat für Sozial- und Wirtschaftsdaten–RatSWD) as a research data center (FDZ) in 2020.
In July 2016, the RatSWD established a complaints office. If you would like to address unresolved problems related to the use of the data that you were unable to resolve with the responsible contact person at the FDZ you may contact the RatSWD by using the contact form on their homepage.
The contact form and details on who is responsible and on the procedure can be found at the following link: www.ratswd.de/beschwerdestelle.
We would like to thank the statutory health insurance providers AOK Bremen/Bremerhaven, Die Techniker (TK), DAK-Gesundheit, and hkk Krankenkasse for their many years of support in establishing the Pharmacoepidemiological Research Database (GePaRD) at BIPS.