Hello,

Nowadays, we have techniques and oversight techniques to ensure that anything printed on paper is a certified copy of the original. However, how do we apply this when copies come from outside clinical trial sites? For example, a patient has an SAE and is admitted to a hospital that isn't the clinical trial site - the documents sent over from the admitting hospital are copies but not labelled as being certified, the originals (perhaps EMR) can never be compared with and a QC check of the copying process can't take place.

Is there a minimum standard that needs to be met in these circumstances?

Any advise would be greatly appreicated!

Thanks,
B