From Paper to Digital: Evaluating Electronic Medical Records and their Compliance with EMA Guidelines in European Clinical Trials.

Abstract

Background: Over the past decade, there has been a significant shift from paper-based to digital medical record management, driven largely by advances in digital technology. This transition has led to widespread adoption of Electronic Medical Records (EMRs), with the expectation that paper documentation will soon be fully replaced. In response, the European Medicines Agency's "Guideline on Computerised Systems in Clinical Trials" outlines essential criteria for validated EMR systems to ensure data integrity and security, and sets standards for electronic source documents in clinical trials.

Methods: From December 2023 to March 2024, the Italian Group of Data Managers and Clinical Research Coordinators (GIDMcrc) conducted an online survey across clinical research sites in Italy, France and Belgium to assess the characteristics of medical records and source documents.

Results: The survey was completed by 37 centres: 70.3% from Italy, 16.2% from France and 13.5% from Belgium. Most sites use a mixed paper/electronic Source Document (SD) system (72.3%), with fewer centres having fully electronic SD systems (13.5%) or fully paper-based systems (16.2%). EMR systems are used in 70.3% of sites, but only 23.8% comply with EMA guidelines for computerised systems. A country-specific analysis was also conducted to further explore the situations in Italy and France/Belgium.

Conclusion: Despite the widespread use of electronic medical records (EMRs) in Italy, France and Belgium, Italy lags behind the other two countries in terms of digitization. Despite the presence of an EMR, many centres still use a mixed system of paper and electronic source documents. There is also a lack of awareness regarding EMA and GCP standards, particularly concerning training and system testing. The higher response rate from Italian centres highlights the need for a larger sample in France and Belgium, and a follow-up survey would be beneficial for assessing progress and refining corrective actions.