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14th Aug 2014, 03:46 PM
#3
Similar question. If the Pharmaceutical company have submitted the updated IB to the MHRA (as required) but deem that the changes to the RSI do not affect the risk/benefit assessment of our trial, as does the Chief Investigator, do we, the academic CTU using the IB, still have to submit the changes to the RSI in the IB as a substantial amendment as per the Grey Guide at a cost of £250?
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