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Staff Resources & Support

SOP 55.015

Sponsor Pharmacovigilance Data

SOP 55.007

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… 

SOP 55.006

Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management

SOP 55.005

Initial Review and Management of Updates to Reference Safety Information

SOP 55.004

Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices

SOP 55.002

Preparation and Submission of the Development Safety Update Report

SOP 55.001

Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)

SOP 53.013

Monitoring Clinical Research – For Cause Monitoring Visit

SOP 53.012

Monitoring Clinical Research – Site Close Out Monitoring visit

SOP 53.011

Sponsor Source Data Requirements and Guidance