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 clinicaltrials.gov?
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…

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

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Our experts share their insights on key real world research topics and trends.

• EU | EMA 2025 Vision for the Regulatory Use of RWE – Connecting the Pieces
• Using RWE to Support Regulatory Decisions – Evidence Considerations and Opportunities
• EU – Applicability of GVPs to the Conduct of Non-Interventional Studies
• What GxPs are Applicable to Non-Interventional (Observational) Studies?
• Quality Standards for Registries – EUnetHTA REQUEST Tool
• Quality Considerations when Using RWD from Registries to Support Regulatory Decisions in the EU
• Quality Considerations when Using RWD from Registries to Support Regulatory Decisions – USA
• USA – Overview of the Current (draft) FDA Guidance and Considerations for Sponsors who are Intending to Use Non-Interventional Study Data to Support Regulatory Submissions to the FDA
• 2021 End of Year Summary
• Document Management and Archiving Requirements for Observational Studies
• Bulgaria – ‘How To’ Guide for Non-Interventional Studies
• EU – Quality Standards for Registry Studies
• Good Clinical Practice for Medical Device Clinical Trials (ISO 14155:2020) – Applicability to Non-Interventional Studies

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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…