<table style="width:100%;">
<colgroup>
<col style="width: 17%" />
<col style="width: 28%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 7%" />
<col style="width: 0%" />
<col style="width: 9%" />
<col style="width: 1%" />
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<col style="width: 0%" />
<col style="width: 12%" />
<col style="width: 0%" />
<col style="width: 5%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="3">Principal Investigator/Program Director (Last, First,
Middle):</td>
<td colspan="12">     </td>
</tr>
<tr class="even">
<td colspan="15"><h2 id="inclusion-enrollment-report">Inclusion
Enrollment Report</h2></td>
</tr>
<tr class="odd">
<td colspan="15"><h1
id="this-report-format-should-not-be-used-for-data-collection-from-study-participants.">This
report format should NOT be used for data collection from study
participants.</h1></td>
</tr>
<tr class="even">
<td>Study Title:</td>
<td colspan="14">     </td>
</tr>
<tr class="odd">
<td>Total Enrollment:</td>
<td colspan="4">     </td>
<td colspan="3">Protocol Number:</td>
<td colspan="7">     </td>
</tr>
<tr class="even">
<td>Grant Number:</td>
<td colspan="3">     </td>
<td colspan="11"></td>
</tr>
<tr class="odd">
<td colspan="15"></td>
</tr>
<tr class="even">
<td colspan="15">PART A. TOTAL ENROLLMENT REPORT: Number of Subjects
Enrolled to Date (Cumulative)<br />
by Ethnicity and Race</td>
</tr>
<tr class="odd">
<td colspan="2" rowspan="2">Ethnic Category</td>
<td colspan="13">Sex/Gender</td>
</tr>
<tr class="even">
<td colspan="5">Females</td>
<td colspan="3">Males</td>
<td colspan="2">Unknown or Not Reported</td>
<td colspan="3">Total</td>
</tr>
<tr class="odd">
<td colspan="2">Hispanic or Latino</td>
<td colspan="5">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>**</td>
</tr>
<tr class="even">
<td colspan="2">Not Hispanic or Latino</td>
<td colspan="5">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2">Unknown (individuals not reporting ethnicity)</td>
<td colspan="5">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Ethnic Category: Total of All Subjects*</td>
<td colspan="5">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td>*</td>
</tr>
<tr class="odd">
<td colspan="2">Racial Categories</td>
<td colspan="13"></td>
</tr>
<tr class="even">
<td colspan="2">American Indian/Alaska Native</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Asian</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Native Hawaiian or Other Pacific Islander</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Black or African American</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">White</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">More Than One Race</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Unknown or Not Reported</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Racial Categories: Total of All Subjects*</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2">*</td>
</tr>
<tr class="even">
<td colspan="15"></td>
</tr>
<tr class="odd">
<td colspan="15">PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics
or Latinos Enrolled to Date (Cumulative)</td>
</tr>
<tr class="even">
<td colspan="2">Racial Categories</td>
<td colspan="4">Females</td>
<td colspan="3">Males</td>
<td colspan="2">Unknown or Not Reported</td>
<td colspan="4">Total</td>
</tr>
<tr class="odd">
<td colspan="2">American Indian or Alaska Native</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Asian</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Native Hawaiian or Other Pacific Islander</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Black or African American</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">White</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">More Than One Race</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Unknown or Not Reported</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Racial Categories: Total of Hispanics or Latinos**</td>
<td colspan="4">     </td>
<td colspan="3">     </td>
<td colspan="2">     </td>
<td colspan="2">     </td>
<td colspan="2">**</td>
</tr>
<tr class="odd">
<td colspan="15"><p>* These totals must agree.</p>
<p>** These totals must agree.</p></td>
</tr>
</tbody>
</table>

PHS 398/2590 (Rev. 05/01) Page [   ]{.underline} **Inclusion Enrollment
Report Format Page**