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Clinical Trial Disclosure

Name of US registry for registering clinical trials
Name of EU registry for reporting clinical trials and results
Select correct option for US disclosure requirements
For FDA approved products, timeline for disclosure of summary results for completed studies is 12M after trial completion
True
False
For EU, timeline for disclosure of summary results for completed pediatric studies is 12M after LPLV
True
False
In CTIS website, what all data goes under trial results. Select all that apply.
Summary of results
Layperson summary of results
Clinical study reports
Case narratives need not to be disclosed
True
False
Redacted text need not be text-searchable
True
False
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