Glasgow Clinical Trials Unit

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