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Research and Innovation

SOP 55.006

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

SOP 55.005

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Management of Reference Safety Information for Clinical Trials of IMPs (including ATMPS)

SOP 55.004

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

SOP 55.002

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Preparation and Submission of the Development Safety Update Report

SOP 55.001

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

SOP 53.013

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Monitoring Clinical Research – For Cause Monitoring Visit

SOP 53.012

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Monitoring Clinical Research – Site Close Out Monitoring visit

SOP 53.011

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Sponsor Source Data Requirements and Guidance

SOP 53.010

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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… 

Continue reading >SOP 53.010

SOP 53.009

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Preparation and Maintenance of a Clinical Trial Monitoring File