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Registerchange of site in a BA/BE study [Regulatives / Guidelines]
Dear Dr.Gunasakaran,
Would fresh BENOC would be associated with additional 8 to 10 weeks of decision from the DCGI? What is the usual time expected? If Sponsor decidfes to shift the CRO sites,are we required to have any additional document from the initial CRO for accepting for the change of site? I am asking thus because, we have been doing a BE study in a CRO in India. The CRO couldnt meet the expected timelines and are postponing the 2nd study due to other reasons. The other studies have received BENOC and we would like to shift the CRO site. Could you please explain further on the process for change of sites please? What documents are required from the previous CRO to be sent to the next CRO? Thanks in advance for your kind help.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Would fresh BENOC would be associated with additional 8 to 10 weeks of decision from the DCGI? What is the usual time expected? If Sponsor decidfes to shift the CRO sites,are we required to have any additional document from the initial CRO for accepting for the change of site? I am asking thus because, we have been doing a BE study in a CRO in India. The CRO couldnt meet the expected timelines and are postponing the 2nd study due to other reasons. The other studies have received BENOC and we would like to shift the CRO site. Could you please explain further on the process for change of sites please? What documents are required from the previous CRO to be sent to the next CRO? Thanks in advance for your kind help.
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Complete thread:
- change of site in a BA/BE study jaspreet 2013-05-10 19:55
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- change of site in a BA/BE study drgunasakaran1 2013-05-11 15:46
- change of site in a BA/BE studyTina 2013-05-14 12:08
- change of site in a BA/BE study raghu 2013-05-18 12:55
- change of site in a BA/BE study vivekanand 2013-05-24 14:14
- change of site in a BA/BE study drgunasakaran1 2013-05-11 15:46
Ing. Helmut Schütz