One of the missions of the CRC is to assist clinical researchers with collecting and reporting adverse events (AEs) that occur during their clinical studies in accordance with regulatory requirements (Swissmedic, EMEA, FDA) and Good Clinical Practice (ICH). The pharmacovigilance services offered by the Clinical Investigation Unit include:
- Developing SOPs, contracts and operating plans
- Preparing AE/SAE forms.
- Processing and analysing cases (imputability, seriousness, expectedness of clinical trial-related adverse events)
- MedDRA coding of adverse events.
- Requests for monitoring and documentation.
- Review of reporting and monitoring requirements by the security team.
- Submissions to Swissmedic.
- Quality control of pharmacovigilance-related activities.
- Preparing line lists for the preparation of annual safety reports (DSUR).
- Record keeping (electronic and paper).