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Amendments for additional statistical analysis / Reasons in FSR for differing statistical methods

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  • Maeve Harte
    26/03/2020 10:19
    GL9 states that 'Reasons should be given if the statistical methods used differed from those proposed in the study protocol'. Some interpret this to be 'differences' to the actual 'statistical method' used for a specific analyses (but the analysis remaining the same otherwise) and an amendment being required for any additional analysis (esp where it impacts the results and conclusion of the study). For this interpretation, different statistical methods applied need to be explained in the FSR and an amendment is not strictly required. Others interpret the above GL9 statement as meaning that amendments are not required if additional (or different) statistical analysis are applied (regardless of whether they impact the conclusions) - as long as the FSR gives reasons. What's your take?
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