SOP 55.006
Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
Selection and Periodic Review of IBs and SmPCs in CTIMPs for Clinical Management
Management of Reference Safety Information for Clinical Trials of IMPs (including ATMPS)
Safety RepSafety Reporting Requirements for Research Other Than Clinical Trials of Investigational Medicinal Products and non CE Marked Medical Devices
Preparation and Submission of the Development Safety Update Report
Pharmacovigilance in Clinical Trials of Investigational Medicinal Products (Glasgow Clinical Trials Unit)
Monitoring Clinical Research – For Cause Monitoring Visit
Monitoring Clinical Research – Site Close Out Monitoring visit
Sponsor Source Data Requirements and Guidance
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…
Preparation and Maintenance of a Clinical Trial Monitoring File