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Guidelines
55 NHS GG&C Pharmacovigilance
SOPs
Forms
Guidelines
Title
Number
Version
Release Date
PV Office – Preparation of Sponsor Safety Reporting Plan, Glasgow Clinical Trials Unit (GCTU) Pharmacovigilance (PV) Office
55.001A
4.0
26/04/21
PV Office – Expediting SUSARs
55.001B
4.0
09/06/23
PV Office – Submitting SUSAR reports to MHRA via ICSR
55.001C
6.0
31/05/23
PV Office – Pharmacovigilance File
55.001F
4.0
19/12/18
PV Office Processing for Clinical Trials of Investigational Medicinal Products
55.001G
3.0
30/04/21
PV Office – Creation and Submission of Development Safety Update Reports
55.002A
4.0
19/12/18
Completion Guidelines: Generic Non-CTIMP Serious Adverse Event Form Version 1.1
55.004A
2.0
15/07/16
PV Office – Processing for Non-CTIMP Studies
55.004B
1.0
19/12/18
PV Office – Handling Drug Alerts
55.005A
4.0
19/12/18
Summary of Product Characteristics (SmPC) & Investigator’s Brochure Checks
55.006A
1.0
28/09/18
PV Office Processing for Clinical Investigations of Non CE Marked medical Devices
55.007A
2.0
01/06/23
Completion Guidelines: Generic CTIMP Serious Adverse Event Form Version 4.0
55.015C
2.0
15/07/16
Completion Guidelines: Generic Parent-Child CTIMP Serious Adverse Event Form Version 4.0
55.015D
2.0
15/07/16