Evaluation of Compliance With Legal Requirements Under the FDA Amendments Act of 2007 for Timely Registration of Clinical Trials, Data Verification, Delayed Reporting, and Trial Document Submission

评估是否符合2007年FDA修正案关于临床试验及时注册、数据核实、延迟报告和试验文件提交的法律要求

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Abstract

This cross-sectional study evaluates clinical trials’ rates of compliance with the legal requirements of the US Food and Drug Administration’s Amendments Act of 2007 for timely registration of clinical trials, data verification, delayed reporting, and trial document submission.

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