Pharmacovigilance

Pharmacovigilance or drug safety in clinical trials is the monitoring of the serious adverse events that occur to patients on trials. Patient safety on clinical trials is continuously monitored and subject to legally binding reporting requirements. All adverse events experienced by a clinical trial patient are recorded on the clinical trial report forms. All events are documented whether they are considered related or not to the study drug. Some of these events are considered serious adverse events (SAEs) if they meet certain criteria, most typically hospitalisation. All of the serious adverse events are reported by the hospital staff within 24 hours to the sponsor of the trial (ICORG).

The pharmacovigilance staff in ICORG assess all of these events and report them (if required) to competent authorities (e.g. the Irish Medicines Board), the concerned national ethics committee (the ethics committee that approved the trial) and all doctors participating in the trial. The serious adverse events that are considered possibly related to the study drug and unexpected for the study drug (suspected unexpected serious adverse reactions (SUSARs)) are reported by ICORG within defined time limits (7 or 15 days). These SUSARs are entered in a European database (Eudravigilance) and subject to consideration and review by the national competent authorities and European Medicines Agency.

A description (narrative) of all clinical trial serious adverse events is written, quality controlled checked and medically reviewed. An SAE narrative forms part of the SUSAR report and all narratives are also included in the final study report. ICORG as sponsor also writes and reports an annual development safety update report during the trial. Since September 2011 all annual safety reports are written in the development safety update report format as outlined in the ICH E2F guideline.

Pharmacovigilance is conducted in adherence to national and EU regulations such as the clinical trial directive 2001/20/EC and associated guidance on adverse event/reactions (‘CT-3’). Pharmacovigilance staff ensure the most up to date regulations are adhered to by attending Irish and European pharmacovigilance information days and by receiving alerts from the IMB and other organisations. ICORG’s pharmacovigilance staff ensure compliance with these regulations by following Standard Operating Procedures. Pharmacovigilance compliance is monitored continuously by the Irish Medicines Board.

There are two full-time pharmacovigilance staff at ICORG. Please contact Pharmacovigilance Manager Mary Stapleton at mary.stapleton@icorg.ie or Pharmacovigilance Associate Sandra Boldrin at sandra.boldrin@icorg.ie if you require further information.