Safety Reporting


At the beginning of November Joanna black attended a day’s course entitled ‘Safety Reporting’ organised by the Research Quality Assurance (RQA) . The remit of the course focused on Clinical Trials of Investigational Medicinal Products and looked closely at the regulations that govern safety reporting and in particular the European Commission guidance document entitled “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use”, better known as CT3. The course also focused on the new Pharmacovigilance Regulations, in relation to Post-Authorisation Safety Studies (PASS) and the obligations imposed on Pharma . Although these new regulations don’t affect academic trials in a direct way, it is important to note that for studies using authorised drugs (in particular newly authorised drugs) there may be an impact on the contractual agreements between Pharma and sponsor whilst supplying the newly authorised drugs for the trials. Another important topic for discussion was the role of Data Safety Monitoring Boards in looking at signals and trends, in post-authorisation studies and how this role is overlooked in the drug development phase of clinical trials and the significance of having a system for the looking at trend signals.