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<tr class="odd">
<td><img src="media/image1.wmf" /></td>
<td colspan="11">Department of Veterans Affairs</td>
<td colspan="10"><strong>INVESTIGATIONAL DRUG INFORMATION
RECORD</strong></td>
</tr>
<tr class="even">
<td colspan="17"><p>1. TITLE OF STUDY</p>
<p>     </p></td>
<td colspan="5"><p>6. SOURCE OF DRUG <em>(If other than manufacturer or
sponsor)</em></p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="17"><p>2. RESPONSIBLE INVESTIGATOR <em>(Individual who
signed Form FD-1572)</em></p>
<p>     </p></td>
<td colspan="5" rowspan="3"><p>7. THERAPEUTIC CLASSIFICATION AND
EXPECTED THERAPEUTIC EFFECT(S)</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="17"><p>3. PRINCIPAL INVESTIGATOR <em>(If different than
responsible investigator)</em></p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="17" rowspan="3"><p>4. ALL DESIGNATIONS FOR DRUG
<em>(Generic and chemical, code, trade-names, other
designations)</em></p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="5"><p>8. DOSAGE FORMS AND STRENGTHS</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="5"><p>9A. IS THIS DRUG A CONTROLLED SUBSTANCE?</p>
<p> YES NO <em>(If “Yes”, complete item 9B)</em></p></td>
</tr>
<tr class="even">
<td colspan="17"><p>5. MANUFACTURER OR OTHER SPONSOR</p>
<p>     </p></td>
<td colspan="5"><p>9B. CLASSIFICATION</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="22"><strong>10. STABILITY AND STORAGE
REQUIREMENTS</strong></td>
</tr>
<tr class="even">
<td colspan="22">A. PRIOR TO MIXING, STORAGE SHOULD BE <em>(Check
applicable box(es))</em></td>
</tr>
<tr class="odd">
<td colspan="7"> AT ROOM TEMPERATURE</td>
<td colspan="4"> IN REFRIGERATOR</td>
<td colspan="4"> IN FREEZER</td>
<td colspan="5"> PROTECTED FROM LIGHT</td>
<td colspan="2"> OTHER(Specify)      </td>
</tr>
<tr class="even">
<td colspan="22">B. AFTER MIXING, DRUG REMAINS STABLE IN REFRIGERATOR
FOR <em>(Check appropriate box and enter quantity)</em></td>
</tr>
<tr class="odd">
<td colspan="5"> <u>     </u> MINUTES</td>
<td colspan="4"> <u>     </u> HOURS</td>
<td colspan="13"> <u>     </u> DAYS</td>
</tr>
<tr class="even">
<td colspan="22"><strong>11. DRUG ADMINISTRATION
PROCEDURES</strong></td>
</tr>
<tr class="odd">
<td colspan="9"><p>A. ROUTES OF ADMINISTRATION</p>
<p><em>(Check appropriate box(es))</em></p></td>
<td colspan="10" rowspan="3"><p>B. ADMINISTRATION DIRECTIONS</p>
<p>     </p></td>
<td colspan="3" rowspan="3"><p>C. RECONSTITUTION DIRECTIONS</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="6"> ORAL</td>
<td colspan="3"> I.V. INFUSION</td>
</tr>
<tr class="odd">
<td colspan="4"> I.V. PUSH</td>
<td colspan="5"> OTHER <u>     </u></td>
</tr>
<tr class="even">
<td colspan="14">12A. DRUG ADMINISTERED BY <em>(Also complete Item
12B)</em></td>
<td colspan="4" rowspan="2"><p>12B. ROUTE</p>
<p>     </p></td>
<td colspan="4" rowspan="2"><p>13. USUAL DOSAGE RANGE</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="7"> A. PHYSICIAN ONLY</td>
<td colspan="7"> B. PROFESSIONAL NURSE</td>
</tr>
<tr class="even">
<td colspan="22"><p>14. KNOWN SIDE EFFECTS AND TOXICITIES</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="10">15A. DOUBLE BLIND?</td>
<td colspan="9" rowspan="2"><p>15B. NAME OF INDIVIDUAL WHO HAS CODE
DESIGNATION</p>
<p>     </p></td>
<td colspan="3">15C. TELEPHONE NUMBERS</td>
</tr>
<tr class="even">
<td colspan="3"> YES</td>
<td colspan="2"> NO</td>
<td colspan="5">(<em>If “Yes”, complete Items 15B and 15C)</em></td>
<td colspan="2"><p>DAYTIME</p>
<p>     </p></td>
<td><p>EVENING</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="22"><p>16. SPECIAL PRECAUTIONS <em>(Include drug
interactions (synergisms, antagonisms), contraindications,
etc.)</em></p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="22"><p>17. ANTIDOTE</p>
<p>     </p></td>
</tr>
<tr class="odd">
<td colspan="22">18. STATUS <em>(Check one)</em></td>
</tr>
<tr class="even">
<td colspan="8"> INVESTIGATIONAL</td>
<td colspan="3"> PHASE II</td>
<td colspan="11"> COMMERCIALLY AVAILABLE</td>
</tr>
<tr class="odd">
<td colspan="8"> PHASE I</td>
<td colspan="3"> PHASE III</td>
<td colspan="11"> OTHER <em>(Specify)      </em></td>
</tr>
<tr class="even">
<td colspan="22"><strong>19. NAMES OF AUTHORIZED
PRESCRIBERS</strong></td>
</tr>
<tr class="odd">
<td colspan="16">A.      </td>
<td colspan="6">B.      </td>
</tr>
<tr class="even">
<td colspan="16">C.      </td>
<td colspan="6">D.      </td>
</tr>
<tr class="odd">
<td colspan="13">20. SIGNATURE OF RESPONSIBLE OR PRINCIPAL
INVESTIGATOR</td>
<td colspan="3">DATE</td>
<td colspan="6" rowspan="6">22. PATIENT IDENTIFICATION <em>(I.D. plate
or give name – last, first, middle)</em></td>
</tr>
<tr class="even">
<td colspan="16"><strong>21. APPROVED BY</strong></td>
</tr>
<tr class="odd">
<td colspan="16">A. SUBCOMMITTEE ON HUMAN STUDIES</td>
</tr>
<tr class="even">
<td colspan="13">21A. SIGNATURE OF CHAIRPERSON</td>
<td colspan="3">DATE</td>
</tr>
<tr class="odd">
<td colspan="16">B. RESEARCH AND DEVELOPMENT COMMITTEE</td>
</tr>
<tr class="even">
<td colspan="13">21B. SIGNATURE OF CHAIRPERSON</td>
<td colspan="3">DATE</td>
</tr>
<tr class="odd">
<td colspan="2"><p>VA FORM</p>
<p>NOV 1989</p></td>
<td colspan="11"><strong>10-9012</strong></td>
<td colspan="9"><p>COMPUTERIZED VERSION</p>
<p>Revised 9/98</p></td>
</tr>
</tbody>
</table>