Integration of Trusted Third Party Software into an EDC System for Data Protection - Compliant Identity Management, Consent Management and Pseudonymization in Medical Research Studies.

Introduction: Medical research studies which involve electronic data capture of sensitive data about human subjects need to manage medical and identifying participant data in a secure manner. To protect the identity of data subjects, an independent trusted third party should be responsible for pseudonymization and management of the identifying data.

Methods: We have developed a web-based integrated solution that combines REDCap as an electronic data capture system with the trusted third party software tools of the University Medicine Greifswald, which provides study personnel with a single user interface for both clinical data entry and management of identities, pseudonyms and informed consents.

Healthcare Needs Patterns and Pattern-Predicting Factors in Dementia: Results of the Comprehensive, Computerized Unmet Needs Assessment from the Randomized, Controlled Interventional Trial InDePendent.

Background: Determining unmet need patterns and associated factors in primary care can potentially specify assessment batteries and tailor interventions in dementia more efficiently.

Objective: To identify latent unmet healthcare need patterns and associated sociodemographic and clinical factors.

Methods: This Latent Class Analysis (LCA) includes n = 417 community-dwelling people living with dementia.

A FHIR has been lit on gICS: facilitating the standardised exchange of informed consent in a large network of university medicine.

Background: The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The "COVID-19 Data Exchange Platform" (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing.

Evaluation of a Health Information Exchange System for Geriatric Health Care in Rural Areas: Development and Technical Acceptance Study.

Background: Patients of geriatrics are often treated by several health care providers at the same time. The spatial, informational, and organizational separation of these health care providers can hinder the effective treatment of these patients.

Objective: This study aimed to develop a regional health information exchange (HIE) system to improve HIE in geriatric treatment.

Triage through telemedicine in paediatric emergency care-Results of a concordance study.

Background: In the German health care system, parents with an acutely ill child can visit an emergency room (ER) 24 hours a day, seven days a week. At the ER, the patient receives a medical consultation. Many parents use these facilities as they do not know how urgently their child requires medical attention.

Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial.

Background: A redistribution of tasks between specialized nurses and primary care physicians, i.e., models of advanced nursing practice, has the potential to improve the treatment and care of the growing number of people with dementia (PwD).

A low-threshold intervention to increase physical activity and reduce physical inactivity in a group of healthy elderly people in Germany: Results of the randomized controlled MOVING study.

Background: Lack of physical activity (PA) and a high level of physical inactivity (PI) are associated with a higher risk for mortality and responsible for several non-communicable diseases including cardiovascular disease. Higher age is associated with a decrease of PA and an increasing level of PI. Studies have shown that interventions in the elderly have the potential to increase the amount of PA and to decrease the level of PI.

Levels of and determinants for physical activity and physical inactivity in a group of healthy elderly people in Germany: Baseline results of the MOVING-study.

Background: Low levels of physical activity (PA) and high levels of physical inactivity (PI) are associated with higher mortality and cardiovascular diseases. Higher age is associated with a decrease of PA, only 2.4-29% of ≥60 year-olds achieve the PA times recommended by WHO.

Toolbox for Research, or how to facilitate a central data management in small-scale research projects.

Background: In most research projects budget, staff and IT infrastructures are limiting resources. Especially for small-scale registries and cohort studies professional IT support and commercial electronic data capture systems are too expensive. Consequently, these projects use simple local approaches (e.

MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial.

Background: Cardiovascular diseases (CVD) are the leading cause of mortality. In 2014, they were responsible for 38.9% of all causes of death in Germany.

Tecla: a telephone- and text-message based telemedical concept for patients with severe mental health disorders--study protocol for a controlled, randomized, study.

Background: Severe mental disorders like psychotic disorders including schizophrenia and schizoaffective disorders have a 12-month-prevalence of 2.6, bipolar disorders of 1.5% in Germany.

A workflow-driven approach to integrate generic software modules in a Trusted Third Party.

Background: Cohort studies and registries rely on massive amounts of personal medical data. Therefore, data protection and information security as well as ethical aspects gain in importance and need to be considered as early as possible during the establishment of a study. Resulting legal and ethical obligations require a precise implementation of appropriate technical and organisational measures for a Trusted Third Party.