The accurate and timely capturing and reporting of serious adverse events is a critical component of a successful trial. Ensuring proper safety reporting procedures to sites, institutional review boards (IRB) and competent regulatory authorities is of utmost importance in protecting subjects/patients as well as the integrity of the clinical study results. Therefore, ongoing safety analyses and reporting are vital and require vigilant attention to ensure all serious adverse events are reported in accordance with regulatory requirements.
At Veristat we work with the sites, monitors, sponsors, and investigators to ensure proper and timely reporting of all safety issues, thus helping ensure the safety of trial volunteers. We provide:
Development of the safety management plan inclusive of outlining the safety management responsibilities between Veristat and the sponsor.
Creation of the pregnancy/safety guidelines and forms to ensure proper reporting of pregnancy and SAEs.
Oversight of the build and maintenance of the safety database based on the requiredments of the study specific protocol (in conjunction with the (Data Management team).
Triage of all initial and follow-up source documentation to ensure criteria for a reportable case(s) are met and review for accuracy and completeness
Assignment of case numbers to all new SAEs
Obtaining the causality assessment from the medical monitor within 24 hours
Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports, laboratory and diagnostics reports, etc)
Drafting of safety narrative(s) according to ICH guidance encompassing medically relevant information and query the site for additional or discrepant information
Completion of MedWatch/CIOMS forms
Provision of Global Submission of SUSARs to regulatory agencies
EV WEB Portal Registration
European Suspected Unexpected Serious Adverse Reaction (SUSAR) Submission
Qualified Person Responsible for Pharmacovigilance (QPPV) surveillance