<table>
<colgroup>
<col style="width: 15%" />
<col style="width: 10%" />
<col style="width: 3%" />
<col style="width: 1%" />
<col style="width: 9%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 4%" />
<col style="width: 1%" />
<col style="width: 2%" />
<col style="width: 1%" />
<col style="width: 0%" />
<col style="width: 1%" />
<col style="width: 1%" />
<col style="width: 7%" />
<col style="width: 2%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 3%" />
<col style="width: 6%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 0%" />
<col style="width: 13%" />
</colgroup>
<tbody>
<tr class="odd">
<td colspan="26"><h1 id="va-new-york-harbor-health-care-system">VA NEW
YORK HARBOR HEALTH CARE SYSTEM</h1></td>
</tr>
<tr class="even">
<td colspan="26">A Request for the <strong>Chief, Pharmacy
Program,</strong> to Review and Approve a Proposed Investigational Drug
Study <em>(If more than one drug in study, attach separate form for
each.)</em></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td>Study Title:</td>
<td colspan="25"></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td>Study No:</td>
<td colspan="2"></td>
<td colspan="5">Principal Investigator:</td>
<td colspan="18"></td>
</tr>
<tr class="odd">
<td>Department:</td>
<td colspan="5"></td>
<td colspan="2">Ext.</td>
<td colspan="6"></td>
<td colspan="8">Approx. Start Date:</td>
<td colspan="4">/ /</td>
</tr>
<tr class="even">
<td colspan="3">Approx. Length of Study:</td>
<td colspan="5"></td>
<td colspan="14">Total Number of Patients:</td>
<td colspan="4"></td>
</tr>
<tr class="odd">
<td colspan="3">Name of Drug:</td>
<td colspan="23"></td>
</tr>
<tr class="even">
<td colspan="3">Pharmacological Activity:</td>
<td colspan="5">Treatment/Study of</td>
<td colspan="18"></td>
</tr>
<tr class="odd">
<td colspan="6">Will the Drug Be Supplied by Sponsor?</td>
<td colspan="5"></td>
<td colspan="5">YES</td>
<td colspan="8"></td>
<td colspan="2">NO</td>
</tr>
<tr class="even">
<td colspan="6">If NO, how will you reimburse Pharmacy?</td>
<td colspan="20"></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td colspan="26"></td>
</tr>
<tr class="odd">
<td colspan="6">Can the Drug be stored at room temp?</td>
<td colspan="5"></td>
<td colspan="5">YES</td>
<td colspan="8"></td>
<td colspan="2">NO</td>
</tr>
<tr class="even">
<td colspan="6">If NO, specify Storage Requirements :</td>
<td colspan="20"></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td colspan="8">Dosage Form (Tabs, Caps, Syringes, Vials, etc.)</td>
<td colspan="18"></td>
</tr>
<tr class="odd">
<td colspan="12">Can the Drug Be Dispensed and Used As Supplied? </td>
<td colspan="6">YES</td>
<td colspan="5"></td>
<td colspan="3">NO</td>
</tr>
<tr class="even">
<td colspan="10">If No, Specify Procedure(s) to obtain Final
Product:</td>
<td colspan="16"><em>e.g. Compounding, Reconstitution, Injection Into IV
Bags</em></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td colspan="26"></td>
</tr>
<tr class="odd">
<td colspan="4">Stability of Final Product:</td>
<td colspan="22"></td>
</tr>
<tr class="even">
<td colspan="6">Storage Requirements of Final Product:</td>
<td colspan="20"></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td colspan="12">Does the Procedure Require A Pharmacist? </td>
<td colspan="5">YES</td>
<td colspan="8"></td>
<td>NO</td>
</tr>
<tr class="odd">
<td colspan="19">If Yes, How will You Reimburse the Pharmacy for
Pharmacist’s Time?</td>
<td colspan="7"></td>
</tr>
<tr class="even">
<td colspan="19"></td>
<td colspan="7"></td>
</tr>
<tr class="odd">
<td colspan="2">PHARMACY SUPPORT</td>
<td colspan="3">YEAR 1</td>
<td colspan="4">YEAR 2</td>
<td colspan="6">YEAR 3</td>
<td colspan="6">YEAR 4</td>
<td colspan="5">YEAR 5</td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="4"></td>
<td colspan="6"></td>
<td colspan="6"></td>
<td colspan="5"></td>
</tr>
<tr class="odd">
<td colspan="7"></td>
<td colspan="6"></td>
<td colspan="7"></td>
<td colspan="6"></td>
</tr>
<tr class="even">
<td colspan="7"><h2 id="signature-of-principal-investigator">SIGNATURE
OF PRINCIPAL INVESTIGATOR</h2></td>
<td colspan="6"></td>
<td colspan="7"><h2 id="date">DATE</h2></td>
<td colspan="6"></td>
</tr>
<tr class="odd">
<td colspan="26"><strong>Chief, Pharmacy Program</strong> has Reviewed
and____<strong>Approved</strong>____<strong>Disapproved</strong> for the
Following Reason(s):</td>
</tr>
<tr class="even">
<td colspan="26"></td>
</tr>
<tr class="odd">
<td colspan="26"></td>
</tr>
<tr class="even">
<td colspan="7"></td>
<td colspan="6"></td>
<td colspan="7"></td>
<td colspan="6"></td>
</tr>
<tr class="odd">
<td colspan="7"><h3 id="signature-of-chief-pharmacy-program">SIGNATURE
OF CHIEF, PHARMACY PROGRAM</h3></td>
<td colspan="6"></td>
<td colspan="7"><h2 id="date-1">DATE</h2></td>
<td colspan="6"></td>
</tr>
</tbody>
</table>

Reviewed/Updated Date: March 24, 2005