Z
zmimshen
Is it ok to submit bench data utilizing de-identified imaging without obtaining IRB/ethics approval?
In the country in which the study is conducted there are no such requirements; however, I was wondering if FDA may refuse to accept the data as a result...
According to CFR 46.101 this type of study is exempt since the data cannot be tracked to an individual and no personal data is revieled however 56.101 does not make this distinction...
Anyone has any input?
In the country in which the study is conducted there are no such requirements; however, I was wondering if FDA may refuse to accept the data as a result...
According to CFR 46.101 this type of study is exempt since the data cannot be tracked to an individual and no personal data is revieled however 56.101 does not make this distinction...
Anyone has any input?