Pharmacovigilance and Safety Reporting

The Medicines for Human Use (Clinical Trials) Regulations 2004 set out specific requirements for the management of serious adverse events (SAE). Of particular importance is the assessment of any event for causality and expectedness.

AEs that are not considered serious should be included on the relevant case report forms (CRFs) as defined in the trial Protocol. This data will be included in the final trial report. SAEs can be classified into different categories:

Each type of SAE is 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. This can result in regulatory approval being withdrawn from an individual project, or, in extreme cases, from all research carried out by the Chief Investigator (CI) or Principal Investigator (PI).

There are a number of responsibilities when managing serious adverse events. Below is a list of responsibilities
for both the Investigator and the Sponsor (for trials sponsored by the Partner Institutions. The KHP CTO will act on behalf of the Partner Organisation trial sponsor).

Related Documentation

Useful Links