SOP 55.007
Safety Reporting In Clinical Trials Of Non CE/UKCA Marked Medical Devices Or CE/UKCA Marked Devices Used Outside Of Their Intended Purpose (Sponsored And Hosted Clinical…
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Research and Innovation
SOP 55.006
Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
SOP 55.005
Management of Reference Safety Information for Clinical Trials of IMPs (including ATMPS)
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
SOP 53.010
Monitoring Clinical Research – Preparation and Management of a Monitoring Plan for a Clinical Trial of an Investigational Medicinal Product/Advanced Medicinal Investigation Product/ Medical Device…