Research and Innovation

Project Management Trial Set-up

Site Set up – Green for Go Process

Sponsor IB Assessment

Sponsor Quality Control of SAEs Processed by the Pharmacovigilance Office

Sponsor Pharmacovigilance Data

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… 

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