Pharmacovigilance and Safety Reporting
Pharmacovigilance (PV) relates to the detection, assessment, understanding and prevention of adverse effects of medicines.
Safety reporting during clinical research is of paramount importance. All clinical research protocols of studies hosted by the Oxford Radcliffe Hospitals NHS Trust should have the safety of participants explicitly addressed.
ICH-GCP as booklet [PDF document] defines the categories of adverse events and the Medicines for Human Use (Clinical Trials) Regulations (2004, 2006) [PDF document] specifies reporting requirements. The DOH Research Governance Framework (2005) also requires participant safety to be given priority.
The OUH NHS Trust does a risk assessment for all hosted clinical trials to assign SAE reporting requirements and in addition has a number of guidance documents and templates for you to use in order to meet the Regulatory requirements: