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jaspreet ☆ 2013-05-10 21:55 (4799 d 02:30 ago) Posting: # 10567 Views: 3,915 |
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what is the regulatory stand in India if we change the site of clinic which has been approved by ethics and BENOC also taken. do we need to take fresh approval from DCGI or simply notifying DCGI is sufficient? Edit: Please see the Policy of the Forum! [Helmut] |
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drgunasakaran1 ★★  2013-05-11 17:46 (4798 d 06:38 ago) @ jaspreet Posting: # 10571 Views: 3,315 |
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❝ what is the regulatory stand in India if we change the site of clinic which has been approved by ethics and BENOC also taken. Dear Mr Jaspreet, You need to get fresh Ethics committee approval and fresh BENOC from DCGI if you change the BA/BE centre for doing bioequivalence study. — 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 |
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Tina ★ India, 2013-05-14 14:08 (4795 d 10:17 ago) @ drgunasakaran1 Posting: # 10583 Views: 3,234 |
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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] |
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raghu ★ India, 2013-05-18 14:55 (4791 d 09:29 ago) @ jaspreet Posting: # 10601 Views: 3,197 |
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Dear jaspreet, ❝ what is the regulatory stand in India if we change the site of clinic which has been approved by ethics and BENOC also taken. Currently DCGI is accepting change of site provided the relevant docuemnts to be submitted. Ensure that the changes between Obtained BE-NOC protocol and to be conducted protocol should be very minimal. ❝ do we need to take fresh approval from DCGI or simply notifying DCGI is sufficient? Notification sufficient. The person who has taken the BE NOC i.e if the sponsor has got BE-NOC then the Sponsor should submit for the change of site. The practices in DCGI office in giving BE-NOCs, Notifications, T-licence etc are changing frequently, need to be updated as and when the changes are made. |
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vivekanand ☆ India, 2013-05-24 16:14 (4785 d 08:11 ago) @ jaspreet Posting: # 10641 Views: 3,081 |
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If the clinical part of the study couducted at one site and rest of the part that is Bioanalytical and Statistical part of the BA/BE study conducted in new site. What is the regulatory stand for this? what are the approvals required. Vivekanand 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] |
Ing. Helmut Schütz