make subordinate diaries are used i...

make subordinate diaries are used in about one-fourth of all clinical trials to consider probable data on primary and secondary endpoints. (1) Part 1 of this four-part series forward developing and implementing subject diaries compared and contrasted traditional paper and electronic diaries. (2)
In that article, we examined the pair methods in the context of existing FDA and ICH regulations and guidance for capturing diary data. We conclud that newer, electronic rules are in fact more compliant with FDA and ICH data standards than traditional paper diaries. The quiet of this series focuses solely forward ...