Policy: Pharmacovigilance and Safety Reporting

The Medicines for Human Use (Clinical Trials) Regulations require that all adverse events in clinical trials are accurately documented and, where necessary, reported to the Sponsor and regulators.  

This policy sets out the principles for recording and reporting 

• Adverse Events (AEs) 

• Adverse Reactions (ARs) and Serious Adverse Reactions (SARs) 

• Serious Adverse Events (SAEs) 

• Suspected Unexpected Serious Adverse Reactions (SUSARs) 

• Important Medical Events (IMEs) 

• Unexpected pregnancies in trial participants (and, where relevant, their partners) 

This policy applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP.