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Thread: Reporting of Race and Ethnicity

  1. #1
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    Reporting of Race and Ethnicity

    Could anyone please advise if you aware of any EU guidelines outlining specific requirements for types of race/ethnicity reporting. For example: the FDA has the following guidance on the collection of Race and Ethnicity Data in Clinical Trials: (http://www.fda.gov/RegulatoryInforma.../ucm126340.htm). I am not aware of any but any help and feedback would be greatly appreciated.

  2. #2
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    You might find these interesting:- EMEA ICH Topic E 5 (R1) Ethnic Factors in the Acceptability of Foreign Clinical Data Sep1998 and EMEA Q&A on ICH E5 (R1) June 2006. May be helpful but probably not the same as the FDA document.

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