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Medical Animation and Communication
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Compilation of Clinical Study Report Appendices
A clinical study report (CSR) is a pivotal document in the drug submission process, which is prepared for presenting methods and results of a clinical trial. The guidelines provided by International Conference on Harmonisation (ICH) are used to prepare a complete CSR. Before even writing a CSR, many writers find it difficult to compile the appendices (contain supplementary information) for submitting CSR to the regulatory bodies. These appendices, when requested by the regulatory authorities, need to be submitted within 48 hours.Read More
