#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:
- What are the Requirements for Clinical Trials?
- Are NIS Covered in the Clinical Trial Regulations?
- Are There Specific Regulations for NIS?
- Are There Specific Regulations for Biomedical Research?
- 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.
Simple!
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