Concept for linking de-identified biomedical research data using a study participant management system

• Published in: Studies in health technology and informatics Vol. 205; p. 848
• Main Authors: Stahmann, Alexander, Bauer, Christian R K D, Schwanke, Jens
• Format: Journal Article
• Language: English
• Published: Netherlands 2014
• Subjects: Biomedical Research - standards; Community Participation; Computer Security - standards; Confidentiality - standards; Electronic Health Records - standards; Germany; Information Storage and Retrieval - standards; Medical Record Linkage - standards; Quality Assurance, Health Care - standards
• ISSN: 0926-9630
• DOI: 10.3233/978-1-61499-432-9-848

Biomedical research projects show an increasing demand of large numbers of participants from different recruiting centers to achieve statistically significant results. The collected types of data are stored in distributed databases and are linked to the participant by different non-resolvable identifiers (layered pseudonyms) for de-identification. To ensure the quality of the gathered data, regular quality assurance analyses are required at each local center. Because of the distributed databases and layered pseudonyms the analyses can only be achieved manually. Therefore, the process is error-prone and laborious. The objective of this paper is to propose a solution concept to automate the manual process by using a local study participant management system. It orchestrates the process and enables the quality assurance analyses within a clinical data warehouse.