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How To Write A Clinical Study Report

This course provides guidance and advice on writing clinical study reports using the ICH E3 guideline on the structure and content of CSRs as a framework. Clinical Study Reports (CSRs) are the end products of individual clinical trials. A well written CSR provides a concise yet comprehensive summary of the trial and represents the outcome of months or years of work by the clinical project team. CSRs are key documents in a regulatory dossier and provide the building blocks of the clinical sections of the submission. The current ICH guidelines will be reviewed and delegates will be guided through the process of developing a CSR with advice and guidance on the content of each section. Examples will be given on the source information to expect, how to pick out the most relevant data, and how to present a summary of the data that meets the expectations of the target audience. The principles of writing safety narratives and compilation of the CSR appendices will also be covered briefly in this course. By the end of this course, you will be able to: - write a CSR that is complete, clear, appropriate and compliant with the ICH E3 guideline - compile a CSR - deal with problems

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Since 1987, we have been delivering quality training to the pharmaceutical, healthcare, CRO and related industries. As well as delivering technical courses supporting clinical research functions, we also offer a wide range of personal development courses to ensure that skills learnt can be applied in the workplace.

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