"The time needed to write the CSR generally depend

"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."

http://www.niche.org.uk/asset/insider-insight...eports.pdf

The CSR is a very long document, but IPIX can get a head start by writing the shell first. From the same source,

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

Now they can import the trial data package into the report and write the analysis and conclusion section. The CSR should be the last piece of information (from IPIX) to the FDA for applying BTD and to the potential partner for a deal.

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Does anyone here know how long it could take to complete the CSR,..?

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