The following frequently asked questions (FAQs) are presented below:
  1. What is the purpose of overseeing and monitoring a clinical trial?
  2. What are oversight and monitoring activities?
  3. What are the important factors in determining the oversight and monitoring strategy?
  4. How should the oversight and monitoring strategy be documented?
  5. How can the oversight and monitoring strategies be adapted?
  6. Is it possible to have different intensity or focus of the oversight and monitoring activities?
  7. Does adaptive monitoring always have to be trial-specific – for example, in relation to the trial risk assessment?
  8. Is it possible that not undertaking any oversight or monitoring is acceptable?
  9. What should the documented oversight and monitoring strategy contain?
  10. Who should review the oversight and monitoring strategy documentation?
  11. Does the strategy documentation need to be global or country specific?
  12. Does the strategy documentation have to be followed?
  13. Can the strategy documentation be amended?
  14. Are there examples of trial documents that outline oversight and monitoring strategy?
  15. What role do oversight committees have in monitoring a clinical trial?
  16. Is it necessary to perform regular on-site visits?
  17. Is it necessary to perform an investigator site assessment visit?
  18. Is it necessary to perform an investigator site initiation visit?
  19. Is it necessary to perform an investigator site close out visit?
  20. What activities comprise “central monitoring” of a clinical trial and should they be documented?
  21. What is statistical monitoring?
  22. Are there any expectations of which metrics or key performance indicators or methodologies should be used in central/statistical monitoring?
  23. What are the benefits of conducting an on-site visit?
  24. How should non-compliance be dealt with when it is identified?
  25. How important is the accuracy of the clinical trial data?
  26. Is it necessary to perform 100% source data verification (SDV)?
  27. How do I show that the monitoring strategy has been complied with?