Report Preparation [Regulatives / Guidelines]

posted by lakshmiprasad – India, 2018-06-20 05:56 (1308 d 20:32 ago) – Posting: # 18926
Views: 1,561

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......

Complete thread:

Activity
 Admin contact
21,831 posts in 4,567 threads, 1,553 registered users;
online 8 (0 registered, 8 guests [including 7 identified bots]).
Forum time: Wednesday 01:28 CET (Europe/Vienna)

Research under a paradigm must be a particularly effective way
of inducing paradigm change.    Thomas S. Kuhn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5