SERIOUS ADVERSE EVENT REPORT FORM

For the purposes of this form, a serious adverse event is any untoward
medical occurrence that results in death, is life-threatening, requires
or prolongs hospitalization, causes persistent or significant
disability/incapacity, results in congenital anomalies/birth defects, or
in the opinion of the investigators represents other significant hazards
or potentially serious harm to research subjects or others. A serious
adverse event is considered unexpected if it is not described in the
Package Insert or in the Investigator's Brochure (for FDA
investigational agents), in the protocol, or in the informed consent
document.

***INSTRUCTIONS:***

Please complete the information requested below and forward \_\_\_
copies to the IRB as soon as possible, but not later than seven (7) days
in the case of death or life-threatening serious adverse events or
within fifteen (15) days after the occurrence of all other forms of
serious adverse events. The IRB office will immediately forward a copy
to the Clinical Director. In addition, continue to follow FDA and the
NIH Office of Biotechnology Activities (OBA) reporting requirements if
your research involves an IND/IDE or gene transfer.

+---------------------------+---+-------------------+------------------+
| ***PROTOCOL #:\_\_\_\_ -  | * |                   |                  |
| \_\_\_\_-                 | P |                   |                  |
| \_\_                      | R |                   |                  |
| \_\_\_\_\_\_\_\_\_\_\_*** | O |                   |                  |
|                           | T |                   |                  |
|                           | O |                   |                  |
|                           | C |                   |                  |
|                           | O |                   |                  |
|                           | L |                   |                  |
|                           | T |                   |                  |
|                           | I |                   |                  |
|                           | T |                   |                  |
|                           | L |                   |                  |
|                           | E |                   |                  |
|                           | : |                   |                  |
|                           | * |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***PRINCIPAL              | I |                   |                  |
| INVESTIGATOR:***          | n |                   |                  |
|                           | s |                   |                  |
|                           | t |                   |                  |
|                           | i |                   |                  |
|                           | t |                   |                  |
|                           | u |                   |                  |
|                           | t |                   |                  |
|                           | e |                   |                  |
|                           | : |                   |                  |
|                           | O |                   |                  |
|                           | f |                   |                  |
|                           | f |                   |                  |
|                           | i |                   |                  |
|                           | c |                   |                  |
|                           | e |                   |                  |
|                           | P |                   |                  |
|                           | h |                   |                  |
|                           | o |                   |                  |
|                           | n |                   |                  |
|                           | e |                   |                  |
|                           | : |                   |                  |
|                           |   |                   |                  |
|                           | F |                   |                  |
|                           | a |                   |                  |
|                           | x |                   |                  |
|                           | : |                   |                  |
|                           | E |                   |                  |
|                           | - |                   |                  |
|                           | m |                   |                  |
|                           | a |                   |                  |
|                           | i |                   |                  |
|                           | l |                   |                  |
|                           | : |                   |                  |
+---------------------------+---+-------------------+------------------+
| # DATE                    | \ |                   |                  |
| OF SERIOUS ADVERSE EVENT: | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | / |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | / |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***LOCATION OF SAE**      |   |                   |                  |
| (e.g., at NIH or          |   |                   |                  |
| elsewhere):*              |   |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***WAS THIS AN UNEXPECTED | Y |                   |                  |
| ADVERSE EVENT?***         | e |                   |                  |
|                           | s |                   |                  |
|                           | \ |                   |                  |
|                           | [ |                   |                  |
|                           | \ |                   |                  |
|                           | ] |                   |                  |
|                           | N |                   |                  |
|                           | o |                   |                  |
|                           | \ |                   |                  |
|                           | [ |                   |                  |
|                           | \ |                   |                  |
|                           | ] |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***BRIEF DESCRIPTION OF   | * |                   |                  |
| SUBJECT(S)** (Do NOT      | S |                   |                  |
| include identifiers.)*    | E |                   |                  |
|                           | X |                   |                  |
|                           | : |                   |                  |
|                           | * |                   |                  |
|                           | M |                   |                  |
|                           | / |                   |                  |
|                           | F |                   |                  |
|                           | * |                   |                  |
|                           | A |                   |                  |
|                           | G |                   |                  |
|                           | E |                   |                  |
|                           | * |                   |                  |
|                           | : |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           | \ |                   |                  |
|                           | _ |                   |                  |
|                           |   |                   |                  |
|                           | D |                   |                  |
|                           | i |                   |                  |
|                           | a |                   |                  |
|                           | g |                   |                  |
|                           | n |                   |                  |
|                           | o |                   |                  |
|                           | s |                   |                  |
|                           | i |                   |                  |
|                           | s |                   |                  |
|                           | : |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***BRIEF DESCRIPTION OF   |   |                   |                  |
| THE NATURE OF THE SERIOUS |   |                   |                  |
| ADVERSE EVENT:***         |   |                   |                  |
+---------------------------+---+-------------------+------------------+
| ***CATEGORY (outcome) OF  |   | ***RELATIONSHIP   |                  |
| THE SERIOUS ADVERSE       |   | OF SERIOUS        |                  |
| EVENT:***                 |   | ADVERSE EVENT TO  |                  |
|                           |   | RESEARCH:***      |                  |
| \[ \] death               |   |                   |                  |
|                           |   | \[ \] 1 =         |                  |
| \[ \]                     |   | unrelated         |                  |
| disability/incapacity     |   | (clearly not      |                  |
|                           |   | related to the    |                  |
| \[ \] life-threatening    |   | research)         |                  |
|                           |   |                   |                  |
| \[ \] congenital          |   | \[ \] 2 =         |                  |
| anomaly/birth defect      |   | unlikely          |                  |
|                           |   | (doubtfully       |                  |
| \[ \]                     |   | related to the    |                  |
| hospitalization-initial   |   | research)         |                  |
| or prolonged              |   |                   |                  |
|                           |   | \[ \] 3 =         |                  |
| \[ \] required            |   | possible (may be  |                  |
| intervention to prevent   |   | related to the    |                  |
| permanent impairment      |   | research)         |                  |
|                           |   |                   |                  |
| \[ \] other               |   | \[ \] 4 =         |                  |
|                           |   | probable (likely  |                  |
|                           |   | related to the    |                  |
|                           |   | research)         |                  |
|                           |   |                   |                  |
|                           |   | \[ \] 5 =         |                  |
|                           |   | definite (clearly |                  |
|                           |   | related to the    |                  |
|                           |   | research)         |                  |
+---------------------------+---+-------------------+------------------+
| ***HAVE SIMILAR ADVERSE   |   | Yes \[ \] No \[   |                  |
| EVENTS OCCURRED ON THIS   |   | \]                |                  |
| PROTOCOL?***              |   |                   |                  |
|                           |   | If "Yes", how     |                  |
|                           |   | many? \_\_\_\_\_  |                  |
|                           |   |                   |                  |
|                           |   | Please Describe:  |                  |
+---------------------------+---+-------------------+------------------+
| ***What steps do you plan |   | \[ \] no action   |                  |
| to take as a result of    |   | required          |                  |
| the adverse event         |   |                   |                  |
| reported above? Provide   |   | \[ \] amend       |                  |
| documentation to the IRB  |   | consent document  |                  |
| for review and approval   |   |                   |                  |
| of any of the steps       |   | \[ \] amend       |                  |
| checked below.***         |   | protocol          |                  |
|                           |   |                   |                  |
|                           |   | \[ \] inform      |                  |
|                           |   | current subjects  |                  |
|                           |   |                   |                  |
|                           |   | \[ \] terminate   |                  |
|                           |   | or suspend        |                  |
|                           |   | protocol          |                  |
|                           |   |                   |                  |
|                           |   | \[ \] other,      |                  |
|                           |   | describe:         |                  |
+---------------------------+---+-------------------+------------------+
| ***INVESTIGATOR'S         |   |                   | ***DATE:***      |
| SIGNATURE:***             |   |                   |                  |
+---------------------------+---+-------------------+------------------+