Implementation of International Chart Review Studies: An Assessment of Ethics and Regulatory Considerations

 

Implementation of International Chart Review Studies: An Assessment of Ethics and Regulatory Considerations

In the absence of suitable secondary sources of healthcare data, chart review studies offer an effective method to capture and analyze real-world data on patient demographics, clinical characteristics and outcomes, treatment patterns, treatment effectiveness, and safety. For successful implementation, knowledge of country-specific ethics and regulatory approval processes, combined with a good understanding of key operational challenges, is paramount.
Implementation of International Chart Review Studies: An Assessment of Ethics and Regulatory Considerations