Bioequivalence and Bioavailability Forum

Hi,

Good morning to all,

I am facing a little confusion in below mentioned statement.

generally clinical study report will prepare as per ICH E3 guidelines (structure and content). if we are going to submit to the FDA guidelines we will follow the fda requirements in report preparation and structure content is as per ICH e3 only. Now i was prepared pilot study report but study was failed. so sponsor has been requested to provide sort/small report. But in the protocol i was mentioned as "report will be prepared as per ICH e3 guidelines and provided same to sponsor".


Now my concern is whether i need to provided Pilot failed small report as ich e3 guidlines or not.

if not required then protocol i was mentioned as "report will be prepared as per ICH e3 guidelines and provided same to sponsor".

In this case what i need to do.... Please suggest......