| Description | Date | Size |
|---|---|---|
| Protocol Deviation Form | 2007-Sep-04 | 774 KB |
| Protocol Safety Review Team Query Form (MS Word) | 2009-Feb-02 | 79.5 KB |
| Protocol Safety Review Team Query Form (PDF) | 2009-Feb-02 | 69.65 KB |
| Reporting AEs That Meet Study Product Hold Criteria Flow Chart | 2008-Oct-16 | 30.74 KB |
| Safety Phone, Expedited Review, and Product Hold Procedures | 2008-Oct-16 | 28 KB |
