A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related to the study. CSRs are the key means by which regulators can assess the outcome of clinical studies. Their format and content are defined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3. CSRs also include Clinical Trial Reports – the new EU terminology for CSRs when the study report pertains to an interventional (rather than non-interventional) clinical trial.
Outline of a CSR
- A synopsis that provides a summary of the content in the CSR.
- A methodology section, which introduces the study compound and the methods for conducting the study.
- The results and conclusions sections, which present the data from the study and a summary of conclusions about the data. Generally, this consists of efficacy and safety results, though it might also include pharmacokinetic(PK) and/or pharmacodynamic(PD) results, as well as results from other exploratory variables.
- All the tables, figures, and lists (TFLs) from the results data, with links to data referenced in the CSR.
- The appendices section of the CSR, including any additional documentation related to the report and/or required by regulatory agencies.
MedTrans has years of experience in writing hundreds of CSRs for all phases of clinical development and across most indications helps our clients to crystallize the essential results that regulators need to know. We work closely with clients to meet the challenge of the large numbers of complex subject narratives often required for CSRs. The CSRs we prepare optimize and streamline the preparation of ensuing CTDs. Our attention to detail, rigorous adherence to timelines, quality-centric focus, and exceptional client and team communication ensure that the CSR we provide is developed, executed, and delivered to exceed expectations.
Contact us today to find out how our clinical study report writing expertise can help you.