All the guidance documents published by the Regulatory Authorities during the COVID-19 Pandemic, highlight the need for risk assessments (RA) to be conducted by the sponsors and CROS. However, conducting RA and developing adequate Risk Management Plans are not easy tasks, and not all the organizations conducting clinical trials have robust QRMs programs. In clinical trials we manage risks every day, this training covers a systematic approach on how to better do it according to ICH GCP E6 (R2).
