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What documents do you provide at the end of a human study?

A complete clinical study report (CSR) as per the ICH-E3 guidelines is provided to the sponsor. This report comprises of study synopsis, detailed study design and plan, treatment description, efficacy and safety variables, primary and secondary endpoints, evaluation scheme, complete study results with tables and graphs, discussions and overall conclusions. Original copies of the case report forms for each volunteer are also sent at the end of the study.

Apart from this regular study updates, site monitoring reports, recruitment reports are sent to the client during the study.