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2014-2015 Supplement to the Common Application for QuestBridge Students Applicant information Check one: Early Decision Regular Decision Legal Name Last/Family/Surname First/Given Birth Date Middle
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What is study report required by?
Study report is required by regulatory authorities to evaluate the safety and efficacy of a new drug or medical device.
Who is required to file study report required by?
The sponsor or manufacturer of the drug or medical device is required to file the study report.
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The study report must be filled out according to the guidelines set by the regulatory authorities, including providing detailed information on the study design, results, and conclusions.
What is the purpose of study report required by?
The purpose of the study report is to provide regulatory authorities with the necessary information to assess the safety and efficacy of a new drug or medical device.
What information must be reported on study report required by?
The study report must include detailed information on the study design, methodology, results, adverse events, and statistical analysis.
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