Core elements of clinical and epidemiological research projects are data protection procedures for the storage and use of personal data. Based on legal regulations, common procedures for implementation of data protection procedures have been established. The TMF e.V. proposed concrete models for distributing roles in data processing. Among others, the earliest possible separation of research data from person-identifying data (IDAT) of the persons is essential. For the administration of IDAT, the role of the data trustee is proposed, which operates both independently of a) the data-entering institution and b) respective research institutions. To implement data protection measures, the data trustee’s tasks include the following:
- Managing patient lists using technical procedures to fault-tolerantly identify persons, identify and merge duplicates as part of the record linkage process.
- Managing Informed Consent documents of patients and study participants electronically and conducting quality assurance procedures.
- Pseudonymisation/ Anonymisation of person-identifying data, e.g. to support pseudonmised storage of research data related to the person, or for data transfer to third parties for research purposes.
- Checks of person-identifying data against external data sources, e.g. registers of residents.
Based on that principle the Independent Trusted Third Party (TTP) of the University Medicine Greifswald was established as a core unit of the University Medicine Greifswald by the decision dated 22.04.2014 of the Board of Directors of the University Medicine Greifswald. With its establishment, the Trusted Third Party is guaranteed independence and autonomy from the University Medicine Greifswald. The data protection and IT security concept of the TTP received a positive vote in 2014 by the Data Protection Officer of Mecklenburg-Western Pomerania and was considered “examplary in many ways”. The concept of the TTP was successfully implemented and continuously adapted according to new regulations like the EU General Data Protection Regulation (EU GDPR). Please find a list with clients here.
Dana Stahl, M.Sc.
Head of Independent Trusted Third Party of the University Medicine Greifswald K.d.ö.R.
Tel.: (+49) 03834 – 86 75 46
Fax: (+49) 03834 – 86 68 43