Using the German National Medication Plan for Clinical Studies in Practice-Based Research Networks.

Area of Science:

• Health Informatics
• Clinical Research Data Management
• Digital Health Records

Background:

• The German National Medication Plan (GNMP) is a digital, mandatory record for chronically ill patients.
• Seamless digital transfer of GNMP data from Patient Data Management Systems (PDMS) to electronic case report forms is crucial for clinical studies.
• Current limitations in standardized export and restricted access to pharmaceutical catalogs hinder direct data integration.

Purpose of the Study:

• To address the lack of digital interoperability of the GNMP for clinical study data evaluation.
• To propose a solution that facilitates efficient and accurate data capture in practice-based research networks (PBRNs).
• To reduce the burden of manual data entry in general practitioner (GP) practices during studies.

Main Methods:

• Development of a semi-automated data export process from PDMS at GP practices.
• Implementation of a manual database search at the study center to decode pharmaceutical information.
• Creation of a semi-automated processing pipeline to manage data flow and workload distribution.

Main Results:

• The proposed solution facilitates the integration of GNMP data into clinical studies.
• Workarounds were implemented to overcome current limitations in data export and accessibility.
• The approach aims to balance the workload between GP practices and study management.

Conclusions:

• The combined semi-automated approach enhances the digital interoperability of the GNMP for research purposes.
• This method improves data accuracy and reduces manual effort in clinical study data capturing.
• The solution supports efficient data evaluation in practice-based research settings.