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Essential Safety Reporting for the Investigator Site

Essential Safety Reporting for the Investigator Site
Product Code: Essential Safety Reporting for the Investigator Site
Availability: In Stock
Price: £100.00

PLEASE NOTE: If you are booking for more than one participant or on behalf of someone else within your organisation you will be required to complete an 'Online Course Registration' form which can be downloaded by clicking here. Please ensure you click the 'Send to Brookwood Academy by E-mail' button at the bottom left of the form once completed. Failing to complete the form will cause delays in processing your order

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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 info@brookwoodacademy.org

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