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Completing the 5/01 Version of the Inclusion Enrollment Report

This report contains two parts.

Part A

In the first section of Part A you are required to enter the total number of female, male, and unknown (subjects whose gender is unknown or not reported) subjects for each of the indicated ethnic categories. In the second section of Part A you are required to enter the total number of female, male, and unknown (subjects whose gender is unknown or not reported) subjects for each of the indicated racial categories. As you enter the information, the display-only Total fields are automatically updated with the entered information.

Note: The total number of all subjects entered in the racial categories must equal the total number of all subjects entered for the ethnic categories. For example, if you have enrollment data for 100 subjects, describe all 100 in terms of ethnicity and all 100 in terms of race.

Part B

In Part B you are required to enter the total number of female, male, and unknown (subjects whose gender is unknown or not reported) Hispanic or Latino subjects.

Note:
The total number of subjects reported in Part B must be equal to or less than the totals reported in Part A.
This total usually reflects a subset of the information reported in Part A. For example, you have enrollment data for 100 subjects and 50 of these subjects reported Hispanic/Latino ethnicity. Part B is used to report the racial information for these 50 Hispanic/Latino subjects.

See Also

Submitting Inclusion Enrollment Reports for Clinical Research

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