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11th Jan 2021, 02:37 PM
#1
Moderator
The version of the SPC used for expectedness assessments must be the version approved by the MHRA. Updated versions of the SPC should be reviewed as these may provide information such as new precautions that could impact on the trial - for example new precautions may necessitate an update to the protocol in relation to inclusion/exclusion criteria or other safety mitigations.
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