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A Risk Analysis Tool for Medical Studies

Year: 2026

Type: book-chapter

Abstract: Clinical research studies face substantial operational and methodological challenges that compromise quality and reproducibility. Traditional risk assessment requires specialized expertise and significant time investment, creating barriers for research teams. With the advent of new agentic AI models, there are emerging opportunities to leverage these processes more effectively. Therefore, this paper proposes an integrated web-based assistant that democratizes risk assessment in observational clinical studies through automated guideline import, structured question-answer workflows, and automated report generation. By combining document-oriented database architecture with workflow orchestration, the proposed tool addresses gaps between commercial quality management systems and practical needs of smaller research teams when conducting observational studies.

Source: Studies in health technology and informatics

DOI: 10.3233/shti260494

Authors: Alexandre Cotorobai, Raquel Paradinha, Jorge M. Silva, João R. Almeida, José L. Oliveira

Institution: University of Aveiro

Language: English

Topic: Electronic Health Records Systems

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: hybrid

OpenAlex ID: W7162011620

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