--------------------------- -------------------------------------------
  ![](media/image1.emf)       **INVESTIGATIONAL DRUG INFORMATION RECORD**
  **VETERANS ADMINISTRATION** 

  --------------------------- -------------------------------------------

+----------------+--------+---+-------+----------+----+---------------+
| 1\. TITLE OF   |        |   |       | 6\.      |    |               |
| STUDY \[       |        |   |       | SOURCE   |    |               |
|                |        |   |       | OF DRUG  |    |               |
|                |        |   |       | (If      |    |               |
|                |        |   |       | other    |    |               |
|                |        |   |       | than     |    |               |
|                |        |   |       | manu     |    |               |
|                |        |   |       | facturer |    |               |
|                |        |   |       | or       |    |               |
|                |        |   |       | sponsor) |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 2\.            |        |   |       | 7\.      |    |               |
| RESPONSIBLE    |        |   |       | THE      |    |               |
| INVESTIGATOR   |        |   |       | RAPEUTIC |    |               |
| (Individual    |        |   |       | CLASSI   |    |               |
| who signed     |        |   |       | FICATION |    |               |
| Form FD-1573)  |        |   |       | AND      |    |               |
|                |        |   |       | EXPECTED |    |               |
|                |        |   |       | THE      |    |               |
|                |        |   |       | RAPEUTIC |    |               |
|                |        |   |       | EFFECTS  |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 3\. PRINCIPAL  |        |   |       | 8\.      |    |               |
| INVESTIGATOR   |        |   |       | DOSAGE   |    |               |
| (If different  |        |   |       | FORMS    |    |               |
| than           |        |   |       | AND      |    |               |
| responsible    |        |   |       | S        |    |               |
| investigator)  |        |   |       | TRENGTHS |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 4\. ALL        |        |   |       | 9A. IS   |    |               |
| DESIGNATIONS   |        |   |       | THIS     |    |               |
| FOR DRUG       |        |   |       | DRUG A   |    |               |
| (Generic and   |        |   |       | CO       |    |               |
| chemical,      |        |   |       | NTROLLED |    |               |
| code,          |        |   |       | SU       |    |               |
| trade-names,   |        |   |       | BSTANCE? |    |               |
| other          |        |   |       |          |    |               |
| designations)  |        |   |       | NO YES   |    |               |
|                |        |   |       | (If      |    |               |
|                |        |   |       | "YES"    |    |               |
|                |        |   |       | complete |    |               |
|                |        |   |       | item 9B) |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 5\.            |        |   |       | 9B.      |    |               |
| MANUFACTURER   |        |   |       | CLASSI   |    |               |
| OR OTHER       |        |   |       | FICATION |    |               |
| SPONSOR        |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| **10.          |        |   |       |          |    |               |
| STABILITY AND  |        |   |       |          |    |               |
| STORAGE        |        |   |       |          |    |               |
| REQUIREMENTS** |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| A. PRIOR TO    |        |   |       |          |    |               |
| MIXING,        |        |   |       |          |    |               |
| STORAGE SHOULD |        |   |       |          |    |               |
| BE (Check      |        |   |       |          |    |               |
| applicable     |        |   |       |          |    |               |
| boxes)         |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
| AT ROOM        |        |   |       |          |    |               |
| TEMPERATURE IN |        |   |       |          |    |               |
| REFRIGERATOR   |        |   |       |          |    |               |
| IN FREEZER     |        |   |       |          |    |               |
| PROTECTED FROM |        |   |       |          |    |               |
| LIGHT OTHER    |        |   |       |          |    |               |
| (Specify)      |        |   |       |          |    |               |
| [              |        |   |       |          |    |               |
|  ]{.underline} |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| B. AFTER       |        |   |       |          |    |               |
| MIXING, DRUG   |        |   |       |          |    |               |
| REMAINS STABLE |        |   |       |          |    |               |
| IN             |        |   |       |          |    |               |
| REFRIGERATOR   |        |   |       |          |    |               |
| FOR (Check     |        |   |       |          |    |               |
| appropriate    |        |   |       |          |    |               |
| box and enter  |        |   |       |          |    |               |
| quantity)      |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|       MINUTES  |        |   |       |          |    |               |
|       HOURS    |        |   |       |          |    |               |
|       DAYS NOT |        |   |       |          |    |               |
| APPLICABLE     |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| **11. DRUG     |        |   |       |          |    |               |
| ADMINISTRATION |        |   |       |          |    |               |
| PROCEDURES**   |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| A. ROUTES OF   |        | B |       |          | C. |               |
| ADMINISTRATION |        | . |       |          | RE |               |
|                |        | A |       |          | CO |               |
| (Check         |        | D |       |          | NS |               |
| appropriate    |        | M |       |          | TI |               |
| boxes)         |        | I |       |          | TU |               |
|                |        | N |       |          | TI |               |
| ORAL I.V. PUSH |        | I |       |          | ON |               |
| I.V. INFUSION  |        | S |       |          | DI |               |
|                |        | T |       |          | RE |               |
|                |        | R |       |          | CT |               |
|                |        | A |       |          | IO |               |
|                |        | T |       |          | NS |               |
|                |        | I |       |          |    |               |
|                |        | O |       |          |    |               |
|                |        | N |       |          |    |               |
|                |        | D |       |          |    |               |
|                |        | I |       |          |    |               |
|                |        | R |       |          |    |               |
|                |        | E |       |          |    |               |
|                |        | C |       |          |    |               |
|                |        | T |       |          |    |               |
|                |        | I |       |          |    |               |
|                |        | O |       |          |    |               |
|                |        | N |       |          |    |               |
|                |        | S |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 12A. DRUG      |        | 1 |       |          | 13 |               |
| ADMINISTERED   |        | 2 |       |          | \. |               |
| BY (Also       |        | B |       |          | U  |               |
| complete item  |        | . |       |          | SU |               |
| 12B)           |        | R |       |          | AL |               |
|                |        | O |       |          | DO |               |
| A. PHYSICIAN   |        | U |       |          | SA |               |
| ONLY B.        |        | T |       |          | GE |               |
| PROFESSIONAL   |        | E |       |          | R  |               |
| NURSE          |        |   |       |          | AN |               |
|                |        |   |       |          | GE |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 14\. KNOWN     |        |   |       |          |    |               |
| SIDE EFFECTS   |        |   |       |          |    |               |
| AND TOXICITIES |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 15A. DOUBLE    | 15B.   |   |       | 15C.     |    |               |
| BLIND?         | NAME   |   |       | T        |    |               |
|                | OF     |   |       | ELEPHONE |    |               |
|                | INDI   |   |       | NUMBERS  |    |               |
|                | VIDUAL |   |       |          |    |               |
|                | WHO    |   |       |          |    |               |
|                | HAS    |   |       |          |    |               |
|                | CODE   |   |       |          |    |               |
|                | DESIG  |   |       |          |    |               |
|                | NATION |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| (If "YES"      |        |   |       | DAYTIME  |    | EVENING       |
| complete       |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
| YES NO items   |        |   |       |          |    |               |
| 15B and 15C)   |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 16\. SPECIAL   |        |   |       |          |    |               |
| PRECAUTIONS    |        |   |       |          |    |               |
| (Include drug  |        |   |       |          |    |               |
| interactions   |        |   |       |          |    |               |
| (synergisms,   |        |   |       |          |    |               |
| antagonisms)   |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 17\. ANTIDOTE  |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 18\. STATUS    |        |   |       |          |    |               |
| (Check one)    |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
| I              |        |   |       |          |    |               |
| NVESTIGATIONAL |        |   |       |          |    |               |
| PHASE II       |        |   |       |          |    |               |
| COMMERCIALLY   |        |   |       |          |    |               |
| AVAILABLE      |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
| PHASE I PHASE  |        |   |       |          |    |               |
| III OTHER      |        |   |       |          |    |               |
| (Specify)      |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| **19. NAMES OF |        |   |       |          |    |               |
| AUTHORIZED     |        |   |       |          |    |               |
| PRESCRIBERS**  |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| A.             |        |   |       | B.       |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| C.             |        |   |       | D.       |    |               |
|                |        |   |       |          |    |               |
|                |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 20\. SIGNATURE |        |   | DATE  | 22\.     |    |               |
| OF RESPONSIBLE |        |   |       | PATIENT  |    |               |
| OR PRINCIPAL   |        |   |       | IDENTI   |    |               |
| INVESTIGATOR   |        |   |       | FICATION |    |               |
|                |        |   |       | (I.D.    |    |               |
|                |        |   |       | plate or |    |               |
|                |        |   |       | give     |    |               |
|                |        |   |       | name -   |    |               |
|                |        |   |       | last,    |    |               |
|                |        |   |       | first,   |    |               |
|                |        |   |       | middle)  |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| **21. APPROVED |        |   |       |          |    |               |
| BY**           |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| A.             |        |   |       |          |    |               |
| SUBCOMMITTEE   |        |   |       |          |    |               |
| ON HUMAN       |        |   |       |          |    |               |
| STUDIES        |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 21A. SIGNATURE |        |   | DATE  |          |    |               |
| OF CHAIRPERSON |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| B. RESEARCH    |        |   |       |          |    |               |
| AND            |        |   |       |          |    |               |
| DEVELOPMENT    |        |   |       |          |    |               |
| COMMITTEE      |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+
| 21B. SIGNATURE |        |   | DATE  |          |    |               |
| OF CHAIRPERSON |        |   |       |          |    |               |
+----------------+--------+---+-------+----------+----+---------------+

VA FORM **10-9012**