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Page 1 of 30AD4833 / EC445 / ProtocolPRODUCT /
PROTOCOL No:AD4833/ EC445Date:17 September 2004IND No.:Not applicableVersion:FINAL 1.1An observational study of patient cohorts who previously received
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Who needs clinical study report?
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Researchers conducting clinical trials
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Regulatory authorities evaluating the safety and efficacy of a medical product
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What is clinical study report?
A clinical study report is a detailed document that summarizes the results and findings of a clinical trial.
Who is required to file clinical study report?
The sponsor of the clinical trial is required to file the clinical study report.
How to fill out clinical study report?
The clinical study report is filled out by summarizing the methods, results, and conclusions of the clinical trial.
What is the purpose of clinical study report?
The purpose of the clinical study report is to provide a comprehensive overview of the clinical trial results for regulatory authorities and other stakeholders.
What information must be reported on clinical study report?
The clinical study report must include information on the study design, participants, results, and conclusions.
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