Glasgow Clinical Trials Unit

SOPs Forms
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 3.0 15/07/16
PV Office – Submitting SUSAR Reports to MHRA via eSUSAR 55.001C 5.0 15/07/16
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 Processing for Clinical Investigations of Non CE Marked Medical Devices 55.001H 1.0 16/11/21
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 1.0 05/05/21
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