Proof of Concept Studies - Do we need to comply with SAE reporting?

Loona

Registered
Dear colleagues,
Do we need to comply with SAE reporting to the Health Authorities for the Proof of Concept studies?

Thank you so much
Anna
 

Jim Wynne

Leader
Admin
Dear colleagues,
Do we need to comply with SAE reporting to the Health Authorities for the Proof of Concept studies?

Thank you so much
Anna
It might help if you were to clarify your question with some context. By "SAE" are you referring to Society of Automotive Engineers? What health authorities, and what type of product?
 

Raisin picker

Quite Involved in Discussions
Dear Anna, if you conduct a pre-market clinical trial in EU, then yes. You will not get an approval from the competent authority and/or ethics if you don't have your AE/SAE handling sorted out.
Might be different in other countries, so I second Jim: Context!
 
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