Visualising Data Models of Patient Registries and Clinical Studies - A Method for Quality Check of EDC Systems.

Introduction: The configuration of electronic data capture (EDC) systems has a relevant impact on data quality in studies and patient registries. The objective was to develop a method to visualise the configuration of an EDC system to check the completeness and correctness of the data definition and rules.

Methods: Step 1: transformation of the EDC data model into a graphical model, step 2: Checking the completeness and consistency of the data model, step 3: correction of identified findings.

DESAM-ForNet Portal: A Novel Infrastructure to Integrate Distributed Information from Practice-Based Research Networks in the German Healthcare System.

Currently the German healthcare system does not have a generic structure to answer research questions in primary care through clinical studies. The DESAM-ForNet initiative was founded as an association of German Practice-Based Research Networks (PBRN), to propose an appropriate and feasible solution. Aim is the integration of distributed, consensual information from practices into a single point of contact.

Development of a Maturity Model for Medical Patient Registries - A Community Approach.

Objective: Development of a generic model to visualize the potential for use and further development of registries to assess the suitability of the registry for a specific purpose.

Methods: Multi-stage community approach.

Results: The maturity model has 9 categories with 105 items.

[Integration of Inventory Data from Cohort and Registry Studies into an Existing Research Network: National Pandemic Cohort Network (NAPKON)].

In the early phase of the COVID-19 pandemic, many local collections of clinical data on patients infected with SARS-CoV-2 were initiated in Germany. As part of the National Pandemic Cohort Network (NAPKON) of the University Medicine Network, the "Integration Core" was established to design the legal, technical and organisational requirements for the integration of inventory data into ongoing prospective data collections and to test the feasibility of the newly developed solutions using use cases (UCs). Detailed study documents of the data collections were obtained.

[Position paper of the German Network for Health Services Research (DNVF) on application-related data collection according to Social Code Book V].

Within the framework of the early benefit assessment, the Federal Joint Committee (G-BA) has been authorised since 2019 by the law for more safety in the supply of pharmaceuticals GSAV to request additional application-related data capture for certain pharmaceutical drugs. This results in certain challenges, especially in the area of conflict between methodological requirements and practical feasibility. The position paper provides an overview and takes up the general regulations defined by the Federal Ministry of Health (BMG) as well as the process defined by the G-BA.

[Memorandum Registry for Health Services Research: Update 2019].

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research".