#9 Practical RWE – Connecting the Dots: How to Identify Country-Specific Requirements for Non-Interventional Studies (NIS)


Psstt…this is a secret…so please don’t tell anybody! 😳 🤔 😂

How do we identify the country-specific requirements for non-interventional studies? Much of our work with non-interventional studies involves determining what is NOT applicable.

We start with clinical trials…and run through this series of questions:

  1. What are the Requirements for Clinical Trials?
  2. Are NIS Covered in the Clinical Trial Regulations?
  3. Are There Specific Regulations for NIS?
  4. Are There Specific Regulations for Biomedical Research?
  5. Is There Local Guidance for Biomedical Research?

The answers to these questions help us to build our country-specific regulatory compliance roadmaps. Part of the process includes contacting competent supervisory authorities (e.g., IEC/IRB) to confirm (verify) NIS requirements.


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