Glasgow Clinical Trials Unit
Home
(current)
About Us
Services
Courses
SOPs
Index
Training Area
Forms
Guidelines
Statistical Advisory Service
Safety Reporting
Contact Us
SOPs
55 NHS GG&C Pharmacovigilance
SOPS
Forms
Guidelines
Title
Number
Version
Release Date
Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)
55.001
8.0
09/06/23
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 and non CE Marked Medical Devices
55.004
5.0
09/06/23
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