Protocol amendment [Study Per­for­mance]

posted by suchit_bhavsar – India, 2013-04-23 13:39 (4796 d 11:37 ago) – Posting: # 10470
Views: 5,574

Hello to all,

Can I have your views, regarding the following situation:

In BA/BE study, amendment is taken e.g for study design, Change in reference medicinal product etc. all this things can change the title of the protocol.

So what will be the protocol title in "Under taking by the Investigator", study report, FDA form 3455, FDA form 1572, randomization etc.


Regards,
Suchit Bhavsar

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