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APPENDIX Federal Requirements for Ethnicity and Race Data Collection and Reporting In October 2007, the United States Department of Education (USE) issued their final guidance to educational institutions
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Visit the FDA website at www.fda.gov.
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wwwfdagovregulatory-informationsearch-fdacollection of race and is a collection of race and ethnicity data maintained by the FDA to monitor and analyze trends in clinical trial participation.
All sponsors of FDA-regulated clinical trials are required to file wwwfdagovregulatory-informationsearch-fdacollection of race and.
wwwfdagovregulatory-informationsearch-fdacollection of race and can be filled out online through the FDA's electronic submission system.
The purpose of wwwfdagovregulatory-informationsearch-fdacollection of race and is to ensure diversity in clinical trial participation and to identify disparities in health outcomes.
Information such as the race and ethnicity of trial participants, recruitment strategies targeted towards underrepresented populations, and any challenges faced in recruiting diverse participants.
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