Pharmacovigilance Pharmacovigilance is the science of detection, assessment, understanding and prevention of the adverse effects of medicines. Pharmacovigilance is the science of detection, assessment, understanding and prevention of the adverse effects of medicines. Systems must be in place to enable the identification, recording, reporting and analysis of safety information so that any safety signals arising during a trial are quickly identified and acted upon. The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended set out specific requirements for pharmacovigilance in Clinical Trials of Investigational Medicinal Products (CTIMPs). ACCORD assumes pharmacovigilance responsibilities for CTIMPs sponsored by the University of Edinburgh and/or NHS Lothian. Receipt and Reporting of Events ● Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) are reported to ACCORD by email to firstname.lastname@example.org or by fax to 0131 242 9447 using the ACCORD SAE form. ● A database is maintained of all SAEs, SARs and SUSARs reported to ACCORD. All entries are fully QC checked. ● ACCORD performs unblinding and expedited reporting of SUSARs to the Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committees (RECs). SUSARs are also reported to sites in multi-site studies and to the relevant Competent Authorities in international studies. Development Safety Update Reports (DSURs) and Line Listings ● Trial specific line listing reports can be generated upon request, with a 1 week notice. ● Line listing reports for Data Monitoring Committees can be generated upon request, with a 2 week notice period. Reference Safety Information (RSI) ● The RSI for any Investigational Medicinal Products (IMPs) in a clinical trial must stay consistent during each annual reporting period. ACCORD regularly reviews each RSI, usually a Summary of Product Characteristics (SmPC) and will advise if a substantial amendment is required towards the end of the reporting period to ensure any changes are approved in time for the next annual reporting period. Sponsor Reviews ● ACCORD performs a quarterly review of SAEs for trials with no Data Management Committee (DMC) or for trials where the DMC has raised a concern. DMC minutes should be sent to ACCORD for review. ● ACCORD performs an annual review of all SAEs for each trial to perform trend analysis.