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15th Feb 2012, 04:09 PM
#1
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.
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1st Sep 2012, 11:25 AM
#2
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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