Can you answer these? If not.. we can help you!  

  1. Why does it matter to know whether adverse event terms are coded at the primary or the secondary preferred-term mapping level in MedDRA?
  2. If you intend to use remote source-data-verification processes in a clinical study, do you need to modify your protocol and informed-consent form?
  3. Why does it matter whether an adverse event is classified as solicited or spontaneously reported?
  4. If you are monitoring a product classed as an Advanced Therapy Medicinal Product (ATMP), what are the implication for causality-assessment of adverse events? 
  5. What are the critical process attributes you need to consider when implementing/changing a global adverse event capture system?
  6. What is the value of having digital health apps as part of your safety surveillance?