Thank you so much for your response!
M
megancouture
@megancouture
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Posts
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Calculations based on PM/pivotal trial data -
Calculations based on PM/pivotal trial dataIs it acceptable to include data in an APS that had to be calculated based on PM/pivotal trial data?
e.g., inclusion of 95% CI error bars in a chart that were calculated using the PM-provided SE and sample mean, or calculating reduction/increase in a primary endpoint from baseline to timepoint X when only the mean change at timepoint X and baseline values are in the PM.
Thanks in advance!
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Consensus GuidelinesHi @Jennifer-Carroll , thank you so much for confirming!
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Consensus GuidelinesHi there,
I am working on an APS that will include consensus guidelines recommendations. Unfortunately, the actual published guidelines are a bit hard to digest due to word order and grammatical issues. Are we allowed to reorganize a clinical recommendation's wording such that it is clearer, or do recommendations need to be verbatim pulled from their publications? We intend to keep wording consistent, but we wish to reorder and split it into bullet points rather than a lengthy sentence.
Thank you in advance!