What is a Clinical Study Report (CSR)?
A Clinical Study Report (CSR) is a key deliverable that is required in many regulatory submissions and containing information about the methods and results of a clinical trial or clinical study. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) provides an E3 guidance which orders the structure of the information presented within the document.
This information includes specifics on the proposed course of treatment, the medical information derived from the patients, patient demographics, and other information that gives insight into the trial methods and results. Specifically, it starts with a summary of the content to be presented within the document followed by a methodology section. Next, the results and data that were collected are presented followed by conclusions about the data. Safety and efficacy results and/or pharmacodynamic and pharmacokinetic results may be found in CSRs depending on what the aims of the specific study were. Section 14 consists of all the TFLs (tables, figures, and lists) which organizes the data from the results. Section 16 is an appendices section and can include any other documents that are required or are related to the report.
This document is mainly written by a medical writer but at times, a statistician can be a part of writing certain sections such as the efficacy results. The data presented in the TFL is what is used by the medical writer to analyze and describe in the CSR. Multiple cross-functional team members will work on the document, and it will most probably go through several drafts before being submitted with each subject matter expert serving as a reviewer for their relevant sections (eg Clinical Development personnel would ensure the trial design is properly described).
CSRs help provide the final key piece of information about a clinical trial for regulators. While they would have seen the study protocol and other information on trial design and the statistical analysis plan prior to study commencement and data collection, the CSR is generally the first time they are seeing detailed overviews of the results. Regulators use the information that is provided to assess the outcome of the clinical studies. CSRs are very long documents as they are highly technical and detailed. A short summary of a CSR known as a CSR synopsis which touches on important points such as where the trial was conducted, phase of the study provided, length of study, the participants, and the objective of the study is also produced for a quicker high-level read of what is in the broader document.