The Clinical Study Report (CSR) is a crucial document in the drug development and regulatory submission process. It is an integrated report of a clinical study of any therapeutic, prophylactic or diagnostic agent in which the clinical and statistical description, presentations and analyses of the study are provided in a single report, incorporating tables and figures into the main text of the report and in appendices. In essence, it compiles all results of a clinical study. To ensure prompt delivery of high-quality CSRs, a medical writer needs to both understand regulatory requirements and have the ability to decode the many aspects of the project knowledgebase.
For human pharmaceuticals, CSRs should be compliant with the International Council on Harmonization (ICH) E3 Guideline: Structure and Content of Clinical Study Reports. Following this guideline, a CSR should contain narratives for deaths, serious adverse events, discontinuations from study drug and other adverse events of interest.
A narrative can be defined as a summary or synopsis of the event that has occurred to a subject participating in the clinical study. The narrative must mention the subject ID of the patient, ethnicity and medical history of the patient, the reason why the study treatment was given to the subject, a detailed version of the medical event that has occurred, what action was taken after the event, a description if the event is related to the study drug or otherwise and a list of all vital signs of the subject. If there is any other notion considered important by the Principal Investigator or delegate, it should be mentioned in the narrative as well.