| Title | Number | Version | Release Date |
|---|---|---|---|
| Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit) | 55.001 | 7.0 | 16/06/20 |
| Preparation and Submission of the Development Safety Update Report | 55.002 | 5.0 | 09/10/19 |
| Safety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products | 55.004 | 4.0 | 09/10/19 |
| Initial Review and Management of Updates to Reference Safety Information | 55.005 | 5.0 | 18/11/21 |
| Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management | 55.006 | 5.0 | 18/11/21 |
| Safety Reporting in Clinical Trials of Medical Devices of Non CE Marked Medical Devices or CE Marked Devices Used Outside of their Intended Purpose (Sponsored and Hosted Clinical Investigations) | 55.007 | 2.0 | 19/07/18 |
| Sponsor Pharmacovigilance Data | 55.015 | 3.0 | 02/09/20 |
| Sponsor IB Assessment | 55.016 | 1.0 | 09/05/22 |
| Sponsor Quality Control of SAEs processed by the Pharmacovigilance Office | 55.017 | 1.0 | 23/11/21 |