English to Russian Medical Medical: Pharmaceuticals

The investigator, or responsible person according to local requirements, will comply with the applicable local regulatory requirements related to the reporting of SAEs to regulatory authorities and the IRB/IEC.
This protocol is being filed under an Investigational New Drug (IND) protocol amendment with the US Food and Drug Administration (FDA).
Once active, a given SAE may qualify as an IND safety report if the SAE is both attributable to the study drug and unexpected.
In this case, all investigators filed to the IND (and associated INDs for the same compound) will receive an expedited investigator safety report, identical in content to the IND safety report submitted to the FDA.
Expedited investigator safety reports are prepared according to the sponsor’s policy and are forwarded to investigators as necessary.