Amendment in Protocol Approval by Ethics Committee [Regulatives / Guidelines]

posted by Jasim Uddin – Bangladesh, 2013-05-16 13:16 (4771 d 18:49 ago) – Posting: # 10590
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Is it permitted in GCP to make any amendment in the Letter of Decision of the approval of protocol by the Ethics Committee? For example, in that approval letter, some important information like the brand name of the test product and of the sponsor is missing. Can Ethics committee issue an amendment to cover those lacking information?

Sincerely

Jasim Uddin

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