WebA clinical study report (CSR) is one of many types of regulatory documents that comprise a marketing application for a drug, biologic, or device. A CSR is a descriptive account of a single clinical trial accompanied by tables, listings, and figures (TLFs) displaying all study data and results. The CSR’s WebAbstract. Corporate Social Responsibility, CSR has become an important element in the business strategy of a growing number of companies worldwide. A large number of …
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ICH E3 Structure and content of clinical study reports - Scientific ...
http://aei.pitt.edu/43368/1/Mullerat_CSR_Europa.pdf WebWhen the SAP and TFL shells are agreed upon and finalized, they will serve as the template for this study’s analysis presentation in the CSR. The principal features of the proposed … WebThis document aims to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. Read together with questions and answers. Keywords: Clinical study report, synopsis, ethics, investigator, patient, study administrative structure, study design, study population, treatment, statistical plan, … pcta visitor use numbers