Regulatory Open Forum

Hello Everyone,

Does anyone know if it is possible to remove a protocol from an IND?  The study is being conducted in Europe and now the plans are not to include any US sites. If so, what is the procedure? The company does not want to inactivate the IND.

Thanks for your assistance.  

David

Hi David

You can remove the protocol from the IND by submitting an IND amendment to do so, but it is ok to leave it in the IND even if there are no US sites included.  You just would need to include results of the study including name of the countries in which it was conducted in your annual report, or for information in the next IND amendment being filed.

Best regards

Leslie