| Description | Date | Size |
|---|
| Protocol Safety Review Team Query Form (MS Word) (Download) | 2009-02-02 | 79.5 KB |
| Protocol Safety Review Team Query Form (PDF) (Download) | 2009-02-02 | 69.65 KB |
| Reporting AEs That Meet Study Product Hold Criteria Flow Chart (Download) | 2008-10-17 | 30.74 KB |
| Safety Phone, Expedited Review, and Product Hold Procedures (Download) | 2008-10-17 | 28 KB |