An Insider’s Insight into Clinical Study Reports

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The time needed to write the CSR generally depends on the complexity of the study design and the size of the data package. How long it will take to write will also depend on the experience and ability of the writer. It is therefore difficult to predict exactly how long a report ‘should’ take to write.

Documents that are useful when writing the shell include:
• Relevant report template
• Final protocol and protocol amendments
• File notes (notes explaining specific incidents during the study)
• Study Procedures/Study Reference Manual
• Statistical/Reporting analysis plan
• Details of ethics committee, monitor, laboratories, etc
• Sponsor report writing SOPs/style guides

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