Essential Safety Reporting for the Investigator Site
- 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 for clinical trials and observational/non-interventional studies.
- Covers requirements for investigators undertaking a clinical trial of an investigational medicinal product.
- Consists of presented material, ‘Did You Know?’ highlights to supplement knowledge and numerous interactions to make the learning more enjoyable.
- Has a narrated and read-only option.
- The course is personalized using the participant’s first name.
- Has great resources including ICH E2A e-book, Essential Pharmacovigilance e-book, CIOMS form and CTCAE quick reference guide for causality assessment.
- Usually undertaken using our learning management system, enabling full tracking of user activity, progress reporting and certification for satisfactory completion.
- Alternatively can be run using a client’s own servers under licence (please enquire).
- Available in English only.
- Personalized using participants first name.
- Takes about 45 mins plus resource reading time.
For more details of group packages or to evaluate the course online please contact us at email@example.com