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

 

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

In the absence of secondary sources of healthcare data, chart review studies can result in patient level data repositories including patient characteristics, care patterns, treatment effectiveness and clinical and safety outcomes. Data can be used to populate economic evaluations, and value dossiers, and inform drug safety assessments. For successful implementation, however, knowledge of country-specific ethics and regulatory approval processes is paramount.