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Thread: Still a bit confused about Reference Safety Information (RSI)

  1. #1
    Forum Member
    Join Date
    Nov 2018

    Still a bit confused about Reference Safety Information (RSI)

    Example scenario - the approved RSI with the CTA was section 4.8 of SPC May2015. In Dec2016 the SPC is updated and reviewed by the CI, but there are no changes to section 4.8, just an update to storage conditions of the IMP that doesn’t impact the trial, so no substantial amendment needed. This version is filed (with the CIs review) as the latest version of the SPC in the TMF. So, for expectedness assessments of SARs should the trial team be using the SPC approved by the MHRA with the original CTA (May2015) or the updated version (Dec2016)? Both have identical events listed in section 4.8.

  2. #2
    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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