A Clinical Study Report (CSR), sometimes also referred to as Clinical Trial Report, is an integrated report of the clinical trial of any therapeutic, prophylactic, or diagnostic agent for submission to the health authorities. It provides a clinical and statistical description, presentations, analyses, and appendices with further details. Its purpose is to present the methodology used (including changes to the protocol) and data obtained. It is also used as source material for several other documents (eg, publications).
Note: The terms ‘clinical trial’ and ‘clinical study’ are synonymous according to ICH E6; however, according to other sources, it is important to distinguish between clinical trial and clinical study. Per Regulation (EU) 536/2014, a clinical trial is a category within the broader group of clinical studies and involves an ‘intervention’ (eg, administration of a study drug).
The CSR presents what was planned, what changed and why, what actually happened, and what was observed. The findings are presented at different levels of detail (ie, text part; in-text tables and figures throughout the report; end-of-text tables and figures; end-of-text subject narratives*; data listings and additional summaries; selected completed Case Report Forms; and Case Report Tabulations [US Archival Listings]). Depending on the complexity of the clinical trial, the CSR (with appendices) may vary enormously in size.
(*) Subject narratives are provided for deaths, other serious adverse events, and other significant adverse events of interest. A narrative provides demographic information and important baseline characteristics, relevant medical history and previous/concomitant medications, the disease being treated, study treatment exposure, a detailed version of the medical event that has occurred, what action was being taken after the event, a description if the event is in any way related to the study drug or not, and additional relevant information from the database (eg, laboratory test results/vital signs if deemed relevant) and other sources.
In general, a full CSR will be written for each clinical trial, but other report types may be created in some instances, including an abbreviated (abridged) CSR (ACSR), a synoptic CSR, or an addendum (supplemental) CSR. For a single clinical trial, there may be multiple CSRs, including separate CSRs for different reporting periods (eg, interim CSR, primary CSR, or final CSR), or for different study parts (eg, substudy report). Hence, there may be different report types per clinical trial.
There are no updates to a CSR, but there can be the need for an addendum CSR to provide additional information to a full CSR.
The CSR is a multidisciplinary document involving a wide range of functions that provide input for the CSR. Their input will be necessary to produce a high-quality document. The earlier sections (methodology) are derived from several other documents (eg, protocol and statistical analysis plan), while the later sections (results) are written based on the statistical output (tables, figures, and listings).
The Emtex Medical Writer can help you with the document development process (eg, writing, circulating for review, and implementing comments) to ensure a well-structured document that is fit for purpose and meets the regulatory reviewer’s needs.