If you conduct observational studies in the USA, you need to comply with the Common Rule (45 CFR 46). How do you know if your study is within the scope of the Common Rule?
The OHRP has issued decision charts dated 23 June 2020 and titled, “Human Subject Regulations Decision Charts: 2018 Requirements,” which highlight the 2018 (and onwards) Common Rule Requirements.
About the Author: stuart.mccully
Stuart is the founder of Phoenix-RWR (www.phoenix-rwr.co.uk) and has 15+ years experience providing regulatory compliance solutions for real world studies, such as non-interventional studies. Stuart is best known for his 'NIS Considerations' reports he created through CHCUK
