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Non-Interventional Study FAQs
  1. What is a non-interventional study (NIS)?
  2. Are there common ethical standards that apply to non-interventional study (NIS)?
  3. Is good clinical practice (GCP) applicable to non-interventional studies?
  4. Do I need to comply with the good pharmacoepidemiology practice (ISPE GPP) guidelines?
  5. What is the difference between an interventional study and a non-interventional study?
  6. Are non-interventional studies clinical trials?
  7. Which code of federal regulations (CFRs) are applicable to non-interventional studies in the USA?
  8. Is 21 CFR 11 applicable to non-interventional studies?
  9. Is 21 CFR 312 applicable to non-interventional studies?
  10. Do I need to publish my non-interventional study on
  11. What is the difference between a postmarket commitment (PMC) and postmarket requirement (PMR) in the USA?
  12. Why do I need ethics committee approval to publish my non-interventional study?
  13. What is a seeding study?
  14. What are the monitoring requirements for non-interventional studies in the USA and Spain?
  15. What are the archiving requirements for non-interventional studies?
  16. Does blood sampling make my non-interventional study interventional and therefore make it a clinical trial?

You can find the answers here…

Regulatory Classification Decision Trees

Classify your study with our regulatory classification decision trees

  1. Generic Regulatory Classification Decision Tree
  2. France – NIS Classification Decision Tree
  3. Germany – NIS Regulatory Classification Decision Tree
  4. Italy – NIS Regulatory Classification Decision Tree
  5. Spain – NIS Regulatory Classification Decision Tree
  6. UK – NIS Regulatory Classification Decision Tree
  7. USA – NIS Regulatory Classification Decision Tree

Access the decision trees here…

Real World Research Glossary

Speaking the same language is important…which is why we’ve created this real world research glossary.

A glossary…is the humble beginnings of regulatory compliance…its starts with a definition…that definition provides regulatory context…that context reveals the applicable regulations.

Explore our comprehensive, referenced, real world research glossary…