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RegisterProtocol amendment [Study Performance]
Dear Mr Suchit Bhavsar,
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
❝ 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
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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
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
Complete thread:
- Protocol amendment suchit_bhavsar 2013-04-23 11:39 [Study Performance]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol amendmentdrgunasakaran1 2013-04-23 16:19
Ing. Helmut Schütz