| Title | Number | Version | Release Date |
|---|---|---|---|
| Sponsor Safety Reporting Plan | 55.001A | 7.0 | 04/10/21 |
| Development Safety Update Report (DSUR) Template | 55.002A | 4.0 | 15/07/16 |
| DSUR Investigator Checklist | 55.002B | 3.0 | 15/07/16 |
| Reference Safety Information Front Sheet | 55.005A | 2.0 | 15/07/16 |
| RSI Summary | 55.005B | 1.0 | 18/11/21 |
| SmPC Tracker for Sponsored/Co-Sponsored Clinical Trials | 55.006A | 2.0 | 15/07/16 |
| IB Tracker for Sponsored/Co-Sponsored Clinical Trials | 55.006B | 2.0 | 15/07/16 |
| SmPC Update Monitor Form | 55.006C | 1.0 | 01/10/18 |
| SAE Processing Form | 55.015A | 7.1 | 08/03/19 |
| SAE QC Review Log | 55.017A | 1.0 | 23/11/21 |