change of site in a BA/BE study [Regulatives / Guidelines]

posted by jaspreet – 2013-05-10 21:55 (4797 d 22:48 ago) – Posting: # 10567
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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?


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