Pharmacovigilance and Safety Reporting

The Medicines for Human Use (Clinical Trials) Regulations set out specific requirements for the recording and reporting of adverse medical occurances effecting clinical trial patients - refered to as Pharmacovigilance.

Different types of Pharmacovigilance events are subject to different reporting requirements. It is vital that this Policy is followed as failure to report incidents, or deal with incidents adequately, can have the potential to jeopardise the safety and well-being of trial subjects.

In short:


Policy: Pharmacovigilance & Safety Reporting (6.6MB)


Related Documentation

Serious Adverse Event Reporting Form (300KB)

 Serious Adverse Event Form Completion Guideline V2.0 03-Nov-16 (400KB)

 eSUSAR User Guidance Document (5KB)

Useful Links

Health Research Authority - Safety Reporting Processes

MHRA guidance on Safety Reporting