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suchit_bhavsar ★ India, 2013-04-23 13:39 (4805 d 13:42 ago) Posting: # 10470 Views: 5,591 |
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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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drgunasakaran1 ★★  2013-04-23 18:19 (4805 d 09:02 ago) @ suchit_bhavsar Posting: # 10474 Views: 4,365 |
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Dear Mr Suchit Bhavsar, ❝ 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. It is preferable to change the version of the protocol if you change the study design and reference medicinal product and capture the Title of the new version of protocol along with version number in the Under taking by the Investigator, study report, FDA form 3455, FDA form 1572, randomization etc., If you are planning to raise protocol amendment only, then the Amended Study Title should be provided in the Under taking by the Investigator", study report, FDA form 3455, FDA form 1572, randomization etc — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz