Hi everyone.
I have seen in several resources (including doi:10.231/JIM.0b013e318262df40 "Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting.") that if the study is a Significant Risk device study, then the investigator (the PI in the hospital that will conduct the study) acts as a Sponsor too. Is that right?
So, to be clear - us, the manufacturing company that is sponsoring the study with Sponsored Research Agreement is not the Sponsor, rather the PI will be the Sponsor as well as the Investigator. and, consequently, all the communication with FDA (including study risk determination, pre-sub and IDE sub) will have to be done by the PI?
Many thanks in advance,
Dina
I have seen in several resources (including doi:10.231/JIM.0b013e318262df40 "Significant risk device studies require that the investigator also function as a sponsor and to file an IDE with the FDA for approval before starting.") that if the study is a Significant Risk device study, then the investigator (the PI in the hospital that will conduct the study) acts as a Sponsor too. Is that right?
So, to be clear - us, the manufacturing company that is sponsoring the study with Sponsored Research Agreement is not the Sponsor, rather the PI will be the Sponsor as well as the Investigator. and, consequently, all the communication with FDA (including study risk determination, pre-sub and IDE sub) will have to be done by the PI?
Many thanks in advance,
Dina