An overview of the investigator site’s safety reporting responsibilities.
This course is essential for all investigators needing to have awareness of their safety reporting obligations arising from the treatment of patients in clinical research.
• Covers the basic principles of safety reporting, key regulations, guidance and best practices that apply to clinical trials and observational/non-interventional studies.
• Consists of presented material, ‘Did You Know?’ highlights to supplement knowledge and numerous interactions to make the learning more enjoyable.
• Has great resources including ICH E2A e-book, Essential Pharmacovigilance e-book, CIOMS form and CTCAE quick reference guide for causality assessment.
For details of packages for training larger groups contact us at firstname.lastname@example.org